Contraception - Articles in Press

Missing IUD and utilization of fluoroscopy for management: a case report - Corrected Proof

Jashoman Banerjee, Roohi Jeelani, Jay M. Berman, Michael P. Diamond — 2012-02-03

Abstract: Introduction: A missing intrauterine device (IUD) poses challenges in diagnosis and treatment. Extrauterine placement of IUDs may cause difficulty in localization. We report a case where use of fluoroscopy just prior to laparoscopic intervention to remove the missing IUD was beneficial.Case: This case report involves a 35-year-old woman who was diagnosed with a missing thread 2 years after insertion of a levonorgestrel IUD (Mirena). Initial diagnostic workup consisting of abdominal X-ray, an ultrasound and diagnostic laparoscopy failed to localize the IUD. We performed an office pelvic ultrasound which confirmed that an IUD was present but could not specifically localize the IUD in the pelvic or abdominal cavity. Hence, we utilized fluoroscopy just prior to laparoscopy to localize and remove the missing device and allow its removal.Conclusion: Various imaging modalities aid in detecting a missing IUD, but proper selection of fluoroscopy helped to localize extrauterine placement of an IUD device. We suggest that utilization of this imaging method just prior to laparoscopy may be of value in selected cases.

Use of the levonorgestrel-releasing intrauterine system in renal transplant recipients: a retrospective case review - Corrected Proof

Tasneem Ramhendar, Paul Byrne — 2012-02-03

Abstract: Our objective was to report on the use of the levonorgestrel-releasing intrauterine system (LNG-IUS, Mirena®) in renal transplant recipients.A retrospective case review was done to identify renal transplant recipients for whom a LNG-IUS had been inserted. All of the women had been seen in the Gynecology Department, Beaumont Hospital, during the period 2000 to 2010. Parameters including age, year of transplantation, indication for insertion, duration of use, discontinuation and complications were documented.The main outcome measure was discontinuation of the LNG-IUS due to pelvic infection.Eleven women were identified who had undergone renal transplantation and were using the LNG-IUS. The mean duration of use was 38 (range 1–84) months. Four women were using the LNG-IUS for contraception and seven were using it for the treatment of menorrhagia, either alone or in conjunction with endometrial ablative procedures. One woman discontinued use in order to conceive. There were no unplanned pregnancies. There were no documented cases of pelvic infection in women using the device.Renal transplant recipients have a critical need for safe and effective contraception. The use of the LNG-IUS has been avoided in the patients due to the theoretical risk of intrauterine device-related pelvic infection in immune-suppressed patients. However, on the basis of our results, we believe that it is acceptable to use the LNG-IUS in renal transplant recipients for both contraception and for the treatment of menorrhagia as the theoretical risk of infection in these immune-suppressed patients does not appear to be increased.

Plan B, One Step not taken: politics trumps science yet again - Corrected Proof

Kelly Cleland, Jeffrey F. Peipert, Carolyn Westhoff, Scott Spear, James Trussell — 2012-02-03

In a stunning move on December 7, Secretary of Health and Human Services Kathleen Sebelius overruled the Food and Drug Administration's judgment that the levonorgestrel-containing emergency contraceptive pill (ECP) Plan B One-Step should be approved for full nonprescription status without an age restriction . FDA Commissioner Margaret Hamburg announced on the same day that the Center for Drug Evaluation and Research (CDER) had closely reviewed the evidence that Plan B One-Step is safe and effective for women of all ages, including data demonstrating that younger adolescents are sufficiently able to understand how to use the product safely without consulting a health care provider . However, in a maneuver unprecedented in the history of the FDA, Secretary Sebelius unilaterally superseded the authority of the Commissioner and ordered that the agency deny the application. Despite the fact that the panel of experts at CDER, which included obstetrician–gynecologists and pediatricians, determined that the data met the regulatory standard for a nonprescription drug, Secretary Sebelius based her rejection of the application on the rather vague argument that it is “common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age” . Instead of being available on pharmacy shelves alongside condoms, nonprescription Plan B One-Step must still be obtained from a pharmacist and only by women or men aged 17 years and over.

A randomized controlled trial of different buccal misoprostol doses in mifepristone medical abortion - Corrected Proof

Erica Chong, Tamar Tsereteli, Nhu Ngoc thi Nguyen, Beverly Winikoff — 2012-02-03

Abstract: Background: An 800-mcg dose of buccal misoprostol following mifepristone has been shown to be highly effective in terminating pregnancies through 63 days since the last menstrual period (LMP) (B. Winikoff, I.G. Dzuba, M.D. Creinin, et al., Two distinct oral routes of misoprostol in mifepristone medical abortion: a randomized controlled trial. Obstet Gynecol 2008; 112: 1303–1310). However, a two 200-mcg misoprostol pill option would simplify administration, and potentially reduce costs and increase women's satisfaction. This study compares a 400-mcg dose (Group I) to an 800-mcg dose (Group II) of buccal misoprostol.Study Design: Eligible and consenting women requesting medical termination of early pregnancy (n=1122) were randomized and instructed to take misoprostol 36 to 48 h after taking 200 mg mifepristone. Follow-up visits occurred 12 to 15 days after mifepristone administration.Results: Ninety-six percent of women in both groups had successful abortions. Women in Group I experienced significantly less vomiting and fever/chills than women in Group II. Ninety-six percent of women in both groups found the procedure very satisfactory or satisfactory.Conclusions: Four hundred micrograms of buccal misoprostol is as effective as the standard 800-mcg dose in terminating pregnancies up to 63 days LMP and reduces side effects.

Building trust for shared services: a model for collaboration between nonprofit reproductive health organizations - Corrected Proof

Clare Coleman, Jodi Magee, Wayne Shields — 2012-01-27

A challenging economy, uncertain political support and evolving health technologies call for innovation, collaboration and fresh thinking for all members of the reproductive health community. Clinical practices in the United States are responding to these challenges by testing and implementing shared support services and information systems, driven by the economic downturn, emergence of electronic medical records, and impending health care laws .

Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study - Corrected Proof

Jeffrey T. Jensen, Sona Grossova Garie, Dietmar Trummer, Jörg Elliesen — 2012-01-27

Abstract: Background: Unscheduled bleeding may affect satisfaction and compliance with extended oral contraceptive (OC) regimens. The bleeding patterns of two variants of a flexible dosing regimen designed to manage intracyclic bleeding problems during extended cycles were compared with that of a conventional OC regimen.Study Design: This was a 1-year, open-label, active-controlled, Phase 3 study conducted in the USA. Healthy women (18–45 years) received an ethinylestradiol (EE) 20 mcg/drospirenone 3 mg OC in two flexible extended regimens or in a conventional 24/4 (i.e., 28-day) regimen. The primary regimen [management of intracyclic bleeding (flexibleMIB) regimen] was an extended dosing regimen that required subjects to initiate 4-day tablet-free intervals after 3 days of breakthrough bleeding/spotting. An alternative extended regimen [active period control (flexibleAPC) regimen] allowed subjects to initiate a 4-day tablet-free interval irrespective of the occurrence of bleeding. Bleeding profiles were compared between treatments. Efficacy and safety outcomes were also assessed.Results: The full analysis set comprised 1864 women (flexibleMIB, N=1406; flexibleAPC, N=232; conventional 24/4, N=226). Over 1 year, subjects in the flexibleMIB group experienced significantly fewer (mean±SD, 40±30) bleeding/spotting days than those in the conventional 24/4 group (52±35). The corresponding value in the flexibleAPC group was 47±33 days. The pregnancy rate in the flexibleMIB group was 1.65 per 100 woman-years (95% confidence interval, 0.96–2.65). All three regimens were well tolerated.Conclusion: A flexibleMIB dosing regimen of EE 20 mcg/drospirenone 3 mg is associated with good contraceptive efficacy and fewer bleeding/spotting days than the conventional 24/4 regimen.

A double-blind, randomized controlled trial of the use of a 50:50 mixture of nitrous oxide/oxygen in legal abortions - Corrected Proof

2012-01-24

Abstract: Background: The study was conducted to evaluate the effectiveness of oxygen/nitrous oxide (O2/NO2) in elective abortions by vacuum aspiration with paracervical block and intravenous paracetamol.Design: This single-center double-blinded randomized study tested O2/NO2 (n=36) and placebo (air, n=36) for additional analgesia in elective abortions with paracervical block and intravenous paracetamol. We assessed intra- and postoperative pain according to both a visual analogic scale rated from 0 to 10 and postoperative analgesic requirements.Results: Mean (±SD) intraoperative, immediate postoperative and late postoperative pain did not differ significantly for patients with O2/NO2 and with air [3.4±2.6 vs. 3.7±3.05 (p=.75), 1.89±2.4 vs. 1.56±2.03 (p=.78), 0.5±0.8 vs. 0.75±1.2 (p=.45)]. The number of patients with scores for low (0–4), moderate (4–7) and severe (7-10) intraoperative, immediate postoperative and late postoperative pain did not differ significantly between the groups. Total adverse effects were significantly higher in the O2/NO2 group [35/180 (19.4%) vs. 18/180 (10%), p=.01].Conclusion: O2/NO2 did not reduce intraoperative or postoperative pain in elective abortions by vacuum aspiration with paracervical analgesia and intravenous paracetamol, and its adverse effect rate was substantial.

Avoiding controversy in international provision of subdermal contraceptive implants - Corrected Proof

David Hubacher, Laneta Dorflinger — 2012-01-24

International agencies work with host country governments to estimate contraceptive needs and to procure commodities at affordable public-sector prices. Depending on the agency and the registration status of the commodity in the given country, three subdermal contraceptive implants are options for purchase: Jadelle® is a two-rod levonorgestrel implant approved for 5 years of continuous use (Bayer HealthCare, Berlin, Germany), Implanon® (Merck & Co., Inc., Whitehouse Station, NJ, USA) is a one-rod etonogestrel implant (approved for 3 years) and Sino-implant (II) (Shanghai Dahua Pharmaceutical Co., Ltd., China) is another two-rod levonorgestrel implant (approved for 4 years).

Immediate postplacental IUD insertion at cesarean delivery: a prospective cohort study - Corrected Proof

Erika Levi, Evelyn Cantillo, Veronica Ades, Erika Banks, Amitasrigowri Murthy — 2012-01-24

Abstract: Background: Immediate postplacental insertion of intrauterine devices (IUDs) during cesarean delivery could reduce a substantial barrier to access to long-term effective contraception. Initiating IUD use prior to discharge from the hospital postpartum eliminates a 6-week postpartum waiting period and an additional office visit.Study Design: This was a prospective cohort study of 90 patients undergoing cesarean delivery. After delivery of the placenta, a copper T380A IUD was inserted into the endometrial cavity through the incision. The study participants were followed up at 6 weeks and 6 months postpartum. This study was conducted at the Weiler Division of the Montefiore Medical Center and at the Jacobi Medical Center in the Bronx, NY.Results: Forty-three (48%) women returned for their 6-week follow-up visits, and among those, no expulsions were recorded. Forty-two (47%) women were reached for phone follow-up at 6 months postpartum, and 80% reported being “happy” or “very happy” with their IUD.Conclusions: Immediate postplacental IUD insertion at the time of cesarean delivery is safe and acceptable.

Complete sperm suppression induced by dienogest plus testosterone undecanoate is associated with down-regulation in the expression of upstream steroidogenic enzyme genes in rat testis - Corrected Proof

Rekha Meena, Man Mohan Misro, Debidas Ghosh, Deoki Nandan — 2012-01-24

Abstract: Background: We had shown that dienogest (DNG) + testosterone undecanoate (TU) induced complete sperm suppression in rats when administered together every 45 days. On the other hand, individual drugs given alone in a similar fashion failed to achieve the same result.Study Design: The present study was therefore undertaken to determine the reason for such a differential sperm suppression and to correlate it with the expression of steroidogenic enzyme genes in the rat testis.Results: Administration of DNG (40 mg/kg body weight [bw]) + TU (25 mg/kg bw) every 45 days for a duration of 90 days induced spermatogenic arrest, leading to a significant reduction in testicular weight and number of precursor germ cells. Flow cytometric analysis further confirmed the same result, leading to a significant shift in the distribution of haploid cells. Measurement of testosterone (serum and intratesticular) was significantly low. Complete sperm suppression coincided with significant down-regulation in the expression of upstream steroidogenic enzyme genes represented serially by cytochrome P450 side-chain cleavage, P450 17α-hydroxylase, 3β-hydroxysteroid dehydrogenase and steroidogenic acute regulatory protein (StAR) in the testis. On the other hand, rats administered with either DNG or TU alone demonstrated incomplete sperm suppression in which the expression of all the above genes remained characteristically nonuniform.Conclusion: Taken together, the above findings corroborate the fact that regulation of expression of three of the upstream steroidogenic enzymes genes and the StAR protein in rat testis is crucial in leading to complete sperm suppression as observed with DNG+TU treatment.

Practice makes perfect: reduction in female condom failures and user problems with short-term experience in a randomized trial - Corrected Proof

Mags Beksinska, Jenni Smit, Carol Joanis, Catherine Hart — 2012-01-24

Abstract: Background: Female condom (FC) failure (breakage, slippage, invagination and misdirection) declines with user experience. Participants in FC performance trials are commonly novice users, and failure rates may be inflated related to inexperience.Study Design: This was a randomized, crossover study assessing preference, safety, acceptability and function of three new FCs (WC, FC2 and V-Amour) among 170 women in Durban, South Africa. FC failure by condom type use period was investigated in women using five FCs of each type.Results: Of the 2411 condoms used during intercourse, 96 failures (breakage, slippage, invagination and misdirection) occurred in 86 condoms (77 condoms had one failure, 8 condoms had two failures, and 1 condom had three failures). Total clinical failure was comparable across FC types. The number of failures in the first condom use period was 58 (7.0%), and this decreased to 21 events (2.6%) in the second and, finally, 17 (2.1%) in the last condom use period. No failures were reported in the last use of the FC in the final condom use period.Conclusions: FC failure rates decreased markedly after use of the first five condoms, regardless of FC type, and stabilized in the second and third use periods. Consideration should be given to the number of condoms used in trials to ensure that failure rates are not inflated by limiting the numbers of condoms used by novice users.

Lack of insurance and parity influence choice between long-acting reversible contraception and sterilization in women postpregnancy - Corrected Proof

Maureen K. Baldwin, Maria I. Rodriguez, Alison B. Edelman — 2012-01-12

Abstract: Background: Disparities in postpregnancy contraception utilization exist, with low-income women disproportionately undergoing sterilization. We assessed the impact of increased intrauterine device (IUD) availability on rates of female sterilization.Study Design: Hospital billing records were used to identify women with an IUD placement or sterilization within 1 year of a pregnancy at a university hospital between Oct 2005 and Jun 2007. Demographic data were compared between women receiving either an IUD or sterilization.Results: There were 365 sterilizations and 223 IUD placements during the study period. IUD placements doubled over the study period from 6% to 12% of all deliveries, while sterilizations remained stable at 11% (p<.001). Demographic variables were examined for women with either public or private insurance who had financial access to both sterilization (n=253) and IUD (n=223). Women receiving sterilization were slightly older (mean age 31 years versus 30 years, p=.03), of higher parity (median three versus two, p<.01), more likely to have had cesarean delivery (69% versus 31%, p<.001) and more likely to have public insurance (77% versus 23%, p<.001) than women who received IUD. Approximately 45% of women delivering in Oregon in 2007 were publicly insured (2010 Maternal and Child Health Update: States Make Progress Towards Improving Systems of Care. National Governor's Association, Table 6. Available at http://www.nga.org/files/live/sites/NGA/files/pdf/MCHUPDATE2010.PDF, accessed Nov 2011). After adjusting for age, parity and type of delivery, women choosing sterilization were more likely to have public insurance than women choosing IUD (odds ratio 8.4, 95% confidence interval 4.7–14.9, p<.0001).Conclusions: Women choosing sterilization are more likely to have public insurance than women choosing IUD and may represent a continued trend toward nonreversible contraception among women of lower socioeconomic status despite available long-acting reversible methods.

Normalization of blood loss in women with heavy menstrual bleeding treated with an oral contraceptive containing estradiol valerate/dienogest - Corrected Proof

2012-01-12

Abstract: Background: The study was conducted to assess the efficacy of estradiol valerate/dienogest (E2V/DNG) administered using an estrogen step-down and progestogen step-up approach in a 28-day regimen in the treatment of heavy menstrual bleeding (HMB) using clinical end points allowing E2V/DNG to be compared with other available medical therapies.Study Design: This was a pooled analysis of data from two identically designed randomized, placebo-controlled, multiple center studies conducted in Europe, Australia and North America that assessed the effectiveness of E2V/DNG in reducing menstrual blood loss (MBL) in women with HMB. Women aged ≥18 years with objectively confirmed HMB were randomized to E2V/DNG (n=220) or placebo (n=135) for seven treatment cycles. Outcomes analyzed included absolute reduction in MBL from baseline, proportion of women successfully treated (defined as MBL below 80 mL and ≥50% reduction in MBL), proportion with MBL below 80 mL and proportion with ≥50% reduction in MBL from baseline.Results: At study end, 63.6% and 11.9% of patients were successfully treated with E2V/DNG and placebo, respectively, with 68.2% and 15.6% of women with MBL below 80 mL, and 70.0% and 17.0% with MBL reduction ≥50% (all p<.001).Conclusion: E2V/DNG is highly effective for the treatment of HMB and is associated with a high rate of treatment success.

Reproductive Health 2011 Scientific Abstracts Las Vegas, NV, September 15–17, 2011 - Corrected Proof

2012-01-12

These scientific abstracts were presented at Reproductive Health 2011, the annual meeting of the Association of Reproductive Health Professionals (ARHP). ARHP was proud to partner with the authors of Contraceptive Technology as well as the Association of Physician Assistants in Obstetrics and Gynecology to deliver the 2011 meeting. This year, 147 abstracts were submitted for consideration for poster presentations, of which three outstanding abstracts — Samantha Garbers (Efficacy of a Self-Administered Computerized Counseling Module in Improving Contraceptive Method Choice and Continuation), Karla Maguire (Intracervical 2% Lidocaine Gel as an Analgesic During Intrauterine Device Insertion: A Randomized Controlled Trial), Jill L. Schwartz (Contraceptive Efficacy, Safety and Acceptability of SILCS, a Novel Single-Sized Diaphragm Used With Contraceptive Gel) — were selected for late-breaking research oral presentations and 51 were selected for poster presentation; however, seven of the authors requested that their work not be published in abstract form. ARHP functioned as the lead partner in the scientific abstract review, and the reviews were completed by a subcommittee of volunteers. The abstracts addressed a wide array of reproductive health topics with international authorship. The Reproductive Health 2011 Educational Planning Committee would like to thank the following reviewers for their hard work:

Reproductive health 2011 module summaries - Corrected Proof

Ellen Cohen — 2012-01-12

Module leader: Robert Hatcher, M.D., M.P.H. Module faculty: Willard Cates, Jr., M.D., M.P.H.; James Trussell, Ph.D., B.Phil; Anita Nelson, M.D.; Michael Policar, M.D.; David Turok, M.D., M.P.H.

Music as an auxiliary analgesic during first trimester surgical abortion: a randomized controlled trial - Corrected Proof

2012-01-12

Abstract: Background: Music has served as an auxiliary analgesic in perioperative settings. This study evaluates the impact of intraoperative music added to routine pain control measures during first trimester surgical abortion.Study Design: We analyzed data from 101 women randomized to undergo abortion with routine pain control measures only (ibuprofen and paracervical block) or with the addition of intraoperative music via headphones. The primary outcome was the change in preoperative and postoperative pain scores on a 100-mm visual analog scale. Secondary outcomes included change in anxiety and vital signs, and satisfaction.Results: Baseline characteristics were similar between groups. The magnitude of increase in pain scores was greater in the intervention than in the control group (+51.0 mm versus +39.3 mm, p=.045). Overall pain control was rated as good or very good by 70% of the intervention and 75% of the control group (p=.65).Conclusions: Intraoperative music added to routine pain control measures increases pain reported during abortion.

Ethnic differences in factors associated with the use of contraception among 20- to 44-year-old women in Estonia and St. Petersburg, Russia - Corrected Proof

Made Laanpere, Kaja Rahu, Kai Part, Tatiana Dubikaytis, Helle Karro — 2012-01-12

Abstract: Background: The aim of this study was to explore factors associated with contraception among 20- to 44-year-old women in different ethnic groups in two Eastern European countries.Study Design: Data on sexually experienced women in need of contraception taken from population-based cross-sectional surveys, conducted in Estonia (n=1680) and in St. Petersburg (n=798), were analyzed. Factors associated with contraception nonuse or the use of unreliable contraceptive methods were explored using multivariate logistic regression analysis.Results: The age-standardized prevalence rate of contraception nonuse or the use of unreliable contraceptive methods was high (27.3% among Estonian-speaking women in Estonia, 39.9% and 42.5% among Russian-speaking women in Estonia and in St. Petersburg, respectively). Age, economic subsistence, high-risk sexual behavior and smoking did not correlate with contraception nonuse or the use of unreliable contraceptive methods among Russian-speaking women in Estonia and in St. Petersburg; this was in contrast to Estonian-speaking women in Estonia. Previous childbirth and abortion reduced the risk of contraception nonuse or the use of unreliable contraceptive methods among Estonian-speaking women in Estonia (adjusted odds ratio, 0.50; 95% confidence interval [CI], 0.31−0.81) but elevated the risk among Russian-speaking women in St. Petersburg (1.99; 1.17−3.40). Abortion, not previous childbirth, was associated with an increased risk among Russian-speaking women in Estonia (2.94; 1.25−6.95).Conclusions: The importance of different risk factors associated with contraceptive use varies between different ethnic groups. Cross-national comparisons are essential for the design of public health policies that decrease the burden of sexual ill health.

Contraception and abortion coverage: what do primary care physicians think? - Corrected Proof

2012-01-12

Abstract: Background: Insurance coverage for family planning services has been a highly controversial element of the US health care reform debate. Whether primary care providers (PCPs) support public and private health insurance coverage for family planning services is unknown.Study Design: PCPs in three states were surveyed regarding their opinions on health plan coverage and tax dollar use for contraception and abortion services.Results: Almost all PCPs supported health plan coverage for contraception (96%) and use of tax dollars to cover contraception for low-income women (94%). A smaller majority supported health plan coverage for abortions (61%) and use of tax dollars to cover abortions for low-income women (63%). In adjusted models, support of health plan coverage for abortions was associated with female gender and internal medicine specialty, and support of using tax dollars for abortions for low-income women was associated with older age and internal medicine specialty.Conclusion: The majority of PCPs support health insurance coverage of contraception and abortion, as well as tax dollar subsidization of contraception and abortion services for low-income women.

Risk factors of surgical evacuation following second-trimester medical termination of pregnancy - Corrected Proof

Maarit Mentula, Oskari Heikinheimo — 2012-01-12

Abstract: Background: Second-trimester medical termination of pregnancy (TOP) is associated with a higher risk of surgical evacuation than earlier medical TOP. Little is known about risk factors of surgical evacuation. Therefore, we assessed these risk factors among women undergoing second-trimester medical TOP.Study Design: Data on 227 women were derived from a prospective randomized trial comparing 1- and 2-day mifepristone–misoprostol intervals in second-trimester medical TOP between 2008 and 2010.Results: The rate of surgical evacuation was 30.8%. The risk of surgical evacuation was increased by a history of curettage [odds ratio (OR) 4.4; 95% confidence interval (CI) 1.7–11.7], fetal indications for TOP (OR 6.1; 95% CI 1.1–34.4), age above 24 years (OR 2.4; 95% CI 1.1–5.3) and a 2-day interval (OR 2.2; 95% CI 1.1–4.1).Conclusions: History of curettage, fetal indication, increasing age and 2-day interval between mifepristone and misoprostol increase the risk of surgical evacuation in cases of second-trimester medical TOP. These findings are important when optimizing clinical service in second-trimester TOP.

Pelvic surgery and hospitalization among Chilean women after nonsurgical sterilization with quinacrine pellets between 1977 and 1989 - Corrected Proof

2012-01-12

Abstract: Background: Concern about quinacrine lingers because of its carcinogenic effects in rats. We describe results of long-term follow-up of women who underwent quinacrine pellet sterilization in Chile between 1977 and 1989 (N=1492).Methods: We interviewed the women or relatives in five rounds of data collection between 1991–1993 and 2006–2007, and reviewed hospital records. Median follow-up was 18.5 years; total person-time was 23,894 woman-years. This analysis focuses on pelvic and abdominal surgeries and conditions. We used survival analysis to estimate the 15-year cumulative probability of hysterectomy, other pelvic surgical procedures and relevant adverse events.Results: Uterine fibroids were by far the most common gynecologic condition, reported by 11% of the cohort. Surgical procedures were recorded for 15% of the cohort; hysterectomy was the most frequent procedure (10%), followed by salpingectomy (2%). The 15-year probability of any pelvic or abdominal procedure was 14.7 per 100 women (95% confidence interval 12.4–16.9). The probability of hysterectomy was 9.3 per 100 women (95% confidence interval 7.4–11.1). Number of quinacrine insertions had little impact on the probabilities.Conclusion: During long-term follow-up of women who received quinacrine pellets for nonsurgical sterilization, the incidence of noncancer adverse outcomes was not unusually high, and no alarming patterns emerged.

ARHP's Annual Reproductive Health Clinical Conference: a laboratory for innovative provider education that can lead to real practice change - Corrected Proof

Ellen Cohen, David Turok — 2012-01-09

What is the best way to develop continuing medical education (CME) programs that help diminish the gap between evidence and practice and that improve provider competence, performance and patient care? Behavioral scientists are zeroing in on some surprising answers that can help us refresh more traditional educational approaches and change the way health care providers learn. We know, for example, that individual knowledge transfer alone is necessary but not sufficient to create practice change and improve competence and patient outcomes. Researchers are also discovering that the didactic lecture — the most commonly used postgraduate teaching method for years — is among the least effective educational interventions for clinicians . Don't get us wrong: the literature supports the effectiveness of CME overall — but only to a point and only in the context of novel approaches to provider education .

A Bridge for postpartum women to Standard Days Method® II. Efficacy study - Corrected Proof

Irit Sinai, Jeannette Cachan — 2012-01-09

Abstract: Background: In a companion article, we described the development of a new fertility-awareness-based Bridge for postpartum women starting with their first postpartum menses and until they are eligible to use the Standard Days Method®. This article presents the results of an efficacy trial to test the Bridge.Study Design: This was a prospective, nonrandomized, multicenter study following 157 women for up to 9 months. Participants were aged 18–39 years, had menstruated at least once since their baby was born, and wished to avoid or delay pregnancy using a fertility-awareness-based approach. Acceptability and correct use were examined. Life table pregnancy rates were calculated to assess method effectiveness.Results: The typical-use failure rate is 11.2 for 6 months of Bridge use.Conclusion: The Bridge can offer significant protection from pregnancy for postpartum women who prefer using a fertility-awareness-based approach to avoiding pregnancy but are not yet eligible to use the Standard Days Method. Counseling should emphasize the importance of following the Bridge guidelines for it to be effective.

A Bridge for postpartum women to Standard Days Method® I. Developing the Bridge - Corrected Proof

Irit Sinai, Jeannette Cachan — 2012-01-09

Abstract: Background: A new fertility-awareness-based Bridge was developed for postpartum women starting with their first postpartum menses and until they are eligible to use the Standard Days Method®. This article describes the development of the Bridge and theoretical efficacy.Study Design: Analysis of a preexisting data set collected in 1986–1990 was performed. Seventy-three breastfeeding women in Australia, Britain and Canada were followed starting 42 days postpartum until they had at least two potentially fertile cycles. We used these data to calculate the theoretical probability of pregnancy from intercourse on different days of the cycle relative to ovulation for postpartum women following the instructions of the Bridge.Results: The fertility-awareness-based family-planning Bridge is theoretically effective for postpartum women until they reestablish cycle regularity and can start using the Standard Days Method.Conclusion: The Bridge can potentially be effective for postpartum women until they are eligible to use the Standard Days Method. Results from an efficacy study of the Bridge are described in a companion article.

Telephone follow-up and self-performed urine pregnancy testing after early medical abortion: a service evaluation - Corrected Proof

Sharon T. Cameron, Anna Glasier, Helen Dewart, Anne Johnstone, Audrey Burnside — 2012-01-09

Abstract: Introduction: Telephone follow-up with a self-performed low-sensitivity urine pregnancy (LSUP) test was introduced at the Royal Infirmary of Edinburgh, Scotland, as an alternative to routine ultrasonography for confirming successful abortion at 2 weeks following early medical abortion (<9 weeks' gestation). Women who screened ‘positive’ at telephone follow-up on the basis of ongoing pregnancy symptoms, scant bleeding or LSUP test result subsequently attended the clinic for a confirmatory ultrasound.Methods: A service evaluation was conducted of the first 8 months of telephone follow-up consisting of a review of the numbers choosing this method of follow-up, the proportion successfully contacted and the efficacy for detecting ongoing pregnancies. In the last 3 months of the study, women were surveyed about their satisfaction with this method of follow-up.Results: Opting for telephone follow-up were 476 out of 619 women (77%). Four women (1%) attended the clinic before telephone follow-up because of pain or bleeding. A total of 410 (87%) of the remaining 472 women were successfully contacted by telephone. Sixty women (15%) screened ‘positive’, three of whom had ongoing pregnancies, and one woman falsely screened ‘negative’. The sensitivity of the telephone follow-up was 75% [95% confidence interval (CI) 30.1–95.4], and specificity was 86% (95% CI 82.2–89). The negative predictive value was 99.7% (95% CI 98.4–99.9), and positive predictive value was 5% (95% CI 1.7–13.7). All women surveyed (n=75) would recommend telephone follow-up to a friend.Conclusion: A telephone follow-up and an LSUP test at 2 weeks are effective for detecting ongoing pregnancy, have good follow-up rates and are popular choices for women.

Effects of parity and gestational age on second-trimester induction–abortion interval in combination with osmotic dilators and gemeprost - Corrected Proof

2012-01-09

Abstract: Background: The true prognostic factors for induced medical abortion are unknown. We sought to investigate the effects of a patient's obstetric parameters on the induction–abortion interval in second-trimester medical abortion.Study Design: We studied 216 consecutive women. Pregnancy was terminated with cervical preparation using osmotic dilators followed by 1 mg vaginal gemeprost administered every 3 h for a maximum of five doses in the first 24 h. All variables are expressed in categorical form (parity, gestational age, maternal age and body mass index) and analyzed by the Cox proportional hazards model.Results: Parity ≥3 was associated with a shorter duration of the induction–abortion interval (adjusted hazards ratio 1.96; 95% confidence interval 1.13–3.40). A gestational age ≥16 weeks was associated with a longer duration of the induction–abortion interval (0.71; 0.52–0.98). No significant association was found in maternal age and body mass index.Conclusions: In combination with osmotic dilators and gemeprost, gestational age and parity are independent factors that affected the induction to abortion interval of second-trimester medical abortion.

Effects of a novel estrogen-free, progesterone receptor modulator contraceptive vaginal ring on inhibition of ovulation, bleeding patterns and endometrium in normal women - Corrected Proof

2011-12-16

Abstract: Background: Progesterone receptor modulators (PRMs) delivered by contraceptive vaginal rings provide an opportunity for development of an estrogen-free contraceptive that does not require daily oral intake of steroids. The objective of this proof-of-concept study was to determine whether continuous delivery of 600–800 mcg of ulipristal acetate (UPA) from a contraceptive vaginal ring could achieve 80% to 90% inhibition of ovulation.Study Design: This was a prospective, controlled, open-labeled, multicenter international trial to examine the effectiveness and safety of this prototype vaginal ring. Thirty-nine healthy women, 21–40 years old and not at risk of pregnancy, were enrolled at three clinic sites. Volunteers participated in a control cycle, a 12-week treatment period and a post-treatment cycle. Pharmacodynamic effects on follicular function and inhibition of ovulation, effects on endometrium, bleeding patterns and serum UPA levels were evaluated.Results: Mean UPA levels during treatment were nearly constant, approximately 5.1 ng/mL throughout the study. Ovulation was documented in 32% of 111 “4-week treatment cycles.” A correlation was observed between serum UPA and degree of inhibition of ovarian activity. There was no evidence of hyperplasia of endometrium, but PRM-associated endometrial changes were frequently observed (41%).Conclusion: In this study, the minimum effective contraceptive dose was not established. Further studies are required testing higher doses of UPA to attain ovulation suppression in a higher percentage of subjects.

Contraceptive care in the VA health care system - Corrected Proof

2011-12-16

Abstract: Background: Little is known about contraceptive care within the Veterans Affairs (VA) health care system. This study was conducted to assess the prevalence of documented contraception by race/ethnicity within the VA and to examine the association between receiving primary care in women's health clinics (WHCs) and having a documented contraceptive method.Study Design: We examined national VA administrative and pharmacy data for 103,950 female veterans aged 18–45 years who made at least one primary care clinic visit in 2008. Multivariable regression models were used to examine the associations between race/ethnicity and receipt of care in a WHC with having a method of contraception while controlling for confounders.Results: Only 22% of women veterans had a documented method of contraception during 2008. After adjusting for potential confounders, Hispanic and African–American women were significantly less likely to have a method compared to whites [odds ratio (OR): 0.82; 95% confidence interval (CI): 0.76–0.88 and OR: 0.85; 95% CI: 0.81–0.89, respectively]. Women who went to WHCs were significantly more likely to have a method of contraception compared to women who went to traditional primary care clinics (OR: 2.05; 95% CI: 1.97–2.14).Conclusions: Overall contraceptive prevalence in the VA is low, but receiving care in a WHC is associated with a significantly higher likelihood of having a contraceptive method.

Who has second-trimester abortions in the United States? - Corrected Proof

Rachel K. Jones, Lawrence B. Finer — 2011-12-16

Abstract: Background: Little is known about the characteristics of second-trimester abortion patients.Study Design: Data come from a national sample of 9493 women obtaining abortions in 2008. Chi-square statistics and logistic regression were used to examine demographic characteristics of women having abortions at 13 or more weeks since last menstrual period (LMP) and women having abortions at 13–15 weeks LMP compared to 16+ weeks LMP.Results: In 2008, 10.3% of abortions in the United States were 13 weeks LMP or later, including 4.0% at 16+ weeks. Groups most likely to have abortions at 13 weeks or later included black women, women with less education, those using health insurance to pay for the procedure and those who had experienced three or more disruptive events in the last year. Groups more likely to have an abortion at 16 weeks or later included black women, higher income women and those paying with health insurance.Conclusions: Black women and those with less education would most benefit from increased availability of first-trimester abortion services.

History of the Chinese Family Planning program: 1970–2010 - Corrected Proof

Cuntong Wang — 2011-12-16

Abstract: Background: China launched a nationwide family planning program offering birth control methods and family planning services in the 1970s. Promotion of the widespread use of long-term contraceptive methods has been one of the program's core strategies. This paper reviews the history of China's Family Planning Program at the national level from 1970 to 2010. Special attention is paid to the history of contraception policy.Study Design: This study provides an overview of the last four decades of the Chinese Family Planning Program. Programmatic goals are highlighted during different time periods, with special attention being paid to the role of contraceptive use and the history of contraceptive policy.Results: The Chinese Family Planning Program has experienced several transitions. It has evolved from the 1970s period of moderate policy, represented by wan, xi, shao (late marriage and childbearing, birth spacing and limited fertility), through the strict one-child policy of 1979 to the early 1990s. From the mid-1990s to the present, a relatively lenient policy has been in force, characterized by client-centered informed choice.Conclusions: The success of the Chinese Family Planning Program has long been heavily dependent on policies advocated by the central government, including programs promoting contraception to reduce fertility rates. The Program also depended on a logistical support system, including organizational safeguards and free provision of contraception and family planning services.

Trends in contraceptive use and determinants of choice in China: 1980–2010 - Corrected Proof

Cuntong Wang — 2011-12-16

Abstract: Background: In China, contraception is the most commonly used practice adopted by couples seeking to limit their number of children and to determine the time interval between births. Since 1980, the implementation of mandatory contraceptive strategy has reduced the fertility rate. Using large-scale data from national statistics and nationally representative sample surveys, the current study aims to assess Chinese trends in contraceptive use and determinants of choice from 1980 to 2010 among married women and men aged 20–49 years.Study Design: Since 1980, national data on contraceptive methods utilization have been gathered by the National Population and Family Planning Commission of the People's Republic of China (NPFPC). Additionally, data from three roughly representative decennial samples (1988, 1997, 2006) of Chinese women of aged 20 to 57 years have been gathered by the NPFPC through the National Family Planning and Reproductive Health Surveys in China.Results: A relatively stable Chinese mode of contraception has been established and maintained since the 1980s. This is characterized by long-term contraceptive use which is still dominant in current China. In addition, China's total contraceptive prevalence rates remain at the highest level across the globe from 1980 to 2010. However, the overall method composition of contraceptive use within China has changed since the mid-1990s. Over the study period, the prevalence rate of sterilization increased from 30.21% in 1980 to 46.47% of married women of reproductive age (20–49 years) in 1994 and then declined to 31.7% in 2010. At the same time, intrauterine device usage increased (39.83% in 1980 to 48.15% in 2010), as did oral contraception (0.3% in 1980 to 0.98% in 2010) and condom usage (2.35% in 1980 to 9.32% in 2010). The results from the multinomial logit model show that an individual's contraceptive choice depends not only on individual characteristics, including ethnicity, age, education level, household registration, region, number of living children and sex of the last living child, but also on the strength of family planning policies. A positive coefficient indicates that the looser the strength of family planning policies is, the more likely the individual is to choose condoms or another short-term contraceptive method.Conclusions: Long-term contraceptive use is still dominant in China. In fact, over the 30-year period (1980–2010) and in comparative world perspective, China continues to have the highest total contraceptive prevalence rate. Additionally, an individual's contraceptive choice is jointly influenced by the strength of family planning policies and individual characteristics.

Ibuprofen prophylaxis for levonorgestrel-releasing intrauterine system insertion: a randomized controlled trial - Corrected Proof

Julie Chor, Julia Bregand-White, Alex Golobof, Bryna Harwood, Allison Cowett — 2011-12-16

Abstract: Background: Despite the high efficacy of the levonorgestrel-releasing intrauterine system (LNG-IUS) in preventing pregnancy, uptake of the intrauterine devices remains low in the United States. Decreasing pain at the time of intrauterine device insertion may be one way to increase interest in this method of contraception.Study Design: We conducted a double-blind, placebo-controlled trial, randomizing women to 800 mg ibuprofen or placebo 45 min prior to LNG-IUS insertion to determine effect of ibuprofen on the pain of LNG-IUS insertion.Results: Eighty-one women completed the study: 44 received ibuprofen, and 37 received placebo. Women in the ibuprofen and placebo groups had similar mean scores for anticipated pain (4.07 and 3.91, respectively; p=.79), pain with tenaculum placement (3.86 and 3.81, respectively; p=.90) and pain with insertion (3.69 and 3.34, respectively; p=.91).Conclusion: Administration of ibuprofen prophylaxis for LNG-IUS insertion does not decrease pain at the time of insertion.

Fifty years on “the pill”: a qualitative analysis of nondaily contraceptive options - Corrected Proof

Beth Sundstrom — 2011-12-16

Abstract: Background: Despite widespread use of “the pill,” half of all pregnancies in the United States remain unplanned. Although nondaily contraceptive options offer a safe, effective alternative to oral contraception, these methods are not widely used.Study Design: A total of 18 women aged 18–23 years completed in-depth interviews. Data analysis included a grounded theory approach and constant-comparative method using open and axial coding to reduce the data and identify themes across the data.Results: Social norms, health uncertainty and limited knowledge emerged as barriers to use of nondaily contraceptive options. Participants understood birth control as “the pill,” and nondaily options were perceived as new and untested. Participants reported a lack of knowledge about the differences between methods and the effectiveness of nondaily options.Conclusions: These findings offer practical suggestions to health communication campaign planners and health care providers to increase uptake of nondaily contraceptive options to improve method satisfaction and reduce unplanned pregnancies among young women.

How women anticipate coping after an abortion - Corrected Proof

Diana Greene Foster, Heather Gould, Katrina Kimport — 2011-12-16

Abstract: Background: There has been some study of women's emotional and psychological well-being after an abortion but no research into women's expectations, at the time of seeking an abortion, of how they will cope after the abortion.Study Design: We abstracted counseling needs assessment forms of 5109 women who sought an abortion at a clinic in 2008.Results: The most common emotions that women anticipate feeling after their abortion are relieved (63%) and confident (52%). A significant minority anticipate feeling a little sad (24%) and a little guilty (21%); 3.4% anticipate poor coping. Women with fetal abnormalities, women who do not have high confidence in their decision, women who have spiritual concerns about abortion, women with a history of depression, women who feel that they were pushed into having an abortion and teenagers are more likely to anticipate poor coping postabortion.Conclusions: The vast majority of women expect to cope well after their abortion. A small number make the decision to terminate their pregnancies even though they anticipate difficulty coping after the procedure.

Unscheduled bleeding with continuous oral contraceptive pills: a comparison of progestin dose - Corrected Proof

2011-12-16

Abstract: Background: Although the use of continuous oral contraceptive pills (OCPs) eliminates scheduled uterine bleeding, unscheduled bleeding is common. The objective of this study was to determine whether progestin dose influences bleeding with use of continuous OCPs.Study Design: This was a secondary data analysis of two other studies of continuous OCPs. Women were eligible if they were switching from a cyclic hormonal contraceptive to a continuous OCP. Women took a 20-mcg ethinyl estradiol (EE)/100-mcg levonorgestrel (LNG) pill or a 20-mcg EE/90-mcg LNG pill for 112 days. The number of bleeding/spotting days was compared between groups using a t test. Sample size was adequate to detect a difference of 8 days of bleeding/spotting over the 112 day study period (β=0.80, α=0.05).Results: Sixty-six subjects were enrolled, 33 in each group. There were no differences in baseline characteristic, missed OCPs or side effects. There were no differences in the mean number of bleeding/spotting days in the first 84 days of the study (90 mcg LNG mean 20.8 (SE 3.6) days versus 100 mcg LNG 17.8 (SE 2.3) days, p=.48), nor was there a difference in the time to amenorrhea (p=.35).Conclusion: Our results do not support the use of one LNG dose over another to decrease the amount of unscheduled bleeding women experience when initiating a continuous OCP.

Primary care physicians' perceptions of rates of unintended pregnancy - Corrected Proof

2011-12-16

Abstract: Background: Primary care physicians (PCPs) treat many women of reproductive age who need contraceptive and preconception counseling.Study Design: To evaluate perceptions of rates of unintended pregnancy, we distributed an online survey in 2009 to 550 PCPs trained in General Internal Medicine or Family Medicine practicing in Western Pennsylvania, Central Pennsylvania, Rhode Island or Oregon.Results: Surveys were completed by 172 PCPs (31%). The majority (54%) of respondents underestimated the prevalence of unintended pregnancy in the United States [on average, by 23±8 (mean±SD) percentage points], and 81% underestimated the risk of pregnancy among women using no contraception [on average, by 35±20 (mean±SD) percentage points]. PCPs also frequently underestimated contraceptive failure rates with typical use: 85% underestimated the failure rate for oral contraceptive pills, 62% for condoms and 16% for contraceptive injections. PCPs more often overestimated the failure rate of intrauterine devices (17%) than other prescription methods. In adjusted models, male PCPs were significantly more likely to underestimate the rate of unintended pregnancy in the United States than female PCPs [adjusted odds ratio (95% confidence interval): 2.17 (1.01–4.66)].Conclusions: Many PCPs have inaccurate perceptions of rates of unintended pregnancy, both with and without use of contraception, which may influence the frequency and the content of the contraceptive counseling they provide.

An overview of four studies of a continuous oral contraceptive (levonorgestrel 90 mcg/ethinyl estradiol 20 mcg) on premenstrual dysphoric disorder and premenstrual syndrome - Corrected Proof

2011-12-07

Abstract: Background: This article presents an overview of four studies that evaluated a continuous oral contraceptive (OC) containing levonorgestrel (90 mcg) and ethinyl estradiol (20 mcg; LNG/EE) for managing premenstrual dysphoric disorder (PMDD) and premenstrual syndrome (PMS).Study Design: Three randomized, double-blind, placebo-controlled trials and one open-label, single-treatment substudy examined mean changes from baseline in the Daily Record of Severity of Problems (DRSP) or Penn Daily Symptom Rating (DSR).Results: Improvements from baseline in mean DRSP and DSR scores were observed, but results were not consistent among the studies. Mean percent improvement of premenstrual symptoms ranged from 30% to 59% in controlled trials and 56% to 81% in an open-label substudy. A large placebo effect was also observed in the placebo-controlled studies. Continuous LNG/EE yielded a favorable safety profile.Conclusions: These data, although not consistent, indicate that continuous LNG/EE may reduce the symptoms of PMDD and PMS, providing an option for women who are appropriate candidates for a continuous OC as a contraceptive, the approved indication for this medication.

Contraception for individuals with sickle cell disease: a systematic review of the literature - Corrected Proof

2011-12-07

Abstract: Background: Women with sickle cell disease have an increased risk of pregnancy-related complications and need safe, effective contraceptive methods to prevent unintended pregnancy.Study Design: We conducted a systematic review to examine the safety of hormonal and intrauterine contraceptive use among women with sickle cell disease.Results: Eight articles met the inclusion criteria. The evidence was of fair to poor quality and suggested that progestin-only and combined hormonal contraception had no effect on frequency of sickle crises or other adverse events and no effect on hematologic parameters associated with sickle crises. No studies examined the risk of thromboembolism in combined hormonal contraceptive users with sickle cell disease. There was insufficient evidence to comment on the safety of intrauterine contraception.Conclusion: While data are limited, there is no evidence to suggest that hormonal contraceptive use among women with sickle cell disease is associated with an increased risk of clinical complications.

Characteristics of presumptive idiopathic disseminated intravascular coagulation during second-trimester induced abortion - Corrected Proof

Sloane York, E. Steve Lichtenberg — 2011-12-02

Abstract: Background: Disseminated intravascular coagulation (DIC) is a serious and relatively uncommon complication of induced or spontaneous abortion or delivery. Occasionally, it has been reported in the absence of predisposing conditions. Little information in the literature describing idiopathic DIC or the treatment of patients with DIC exists.Study Design: From 2002 through 2008, 24 cases of presumptive idiopathic DIC occurred following dilation and evacuation (D&E) abortion between 13 5/7 and 23 6/7 weeks' estimated gestational age at a Midwestern ambulatory surgical center. The characteristics of each patient, their pregnancies and surgical experiences were examined and compared with a temporally matched control group of D&E patients. We explored whether the index cases had a predominance of any historical, clinical or reproductive characteristics compared with controls matched for demographic and reproductive landmarks.Results: Overall incidence of presumptive idiopathic DIC was 1.8 per 1000 D&E cases. Compared with matched controls, there was a greater likelihood of DIC with more advanced gestation (p=.009); no case of DIC was under 17 weeks' gestational age. Increased bleeding occurred at a mean time of 153 min after completion of surgery (range, 55-491 min; median, 131 min). Nineteen of 24 cases were successfully treated at the surgical center after receiving 6 to 8 units of fresh-frozen plasma (FFP); 5 cases were transferred to a hospital for further treatment.Conclusions: The abnormal bleeding of presumptive DIC typically begins to appear within 2 h after uncomplicated D&E and is more likely to occur at 17 weeks' estimated gestational age and more. With rapid diagnosis and treatment, most patients were able to be treated in an outpatient setting with up to 6 to 8 units of FFP and rehydration.

The effect of perioperative ketorolac on pain control in pregnancy termination - Corrected Proof

Natalie E. Roche, Dongchen Li, Denise James, Adam Fechner, Vasanti Tilak — 2011-12-02

Abstract: Background: The study was conducted to evaluate the effect of perioperative ketorolac on pain associated with first-trimester aspiration abortion.Study Design: A double-blind, randomized, placebo-controlled trial was performed involving pregnant women up to 14 weeks' gestation who desired pregnancy termination. Subjects were randomized to receive ketorolac 30 mg intravenously (n=31) or placebo (n=45) at the time of induction of anesthesia. Postoperative pain was assessed using a visual analog scale (VAS). The primary outcome was pain control as determined by VAS score. Secondary measures of patient use of supplemental postoperative pain medications and patient satisfaction were assessed.Results: Subjects in the ketorolac group had lower postoperative pain scores on the VAS at all time points compared to the placebo group, but the difference was not statistically significant. The ketorolac group used less postoperative acetaminophen compared to the placebo group (6.5% versus 35.6%), respectively. Subjects in the placebo group and the ketorolac group had similar requirements for postoperative narcotics in the recovery room (22.2% versus 19.4%). Patient satisfaction with pain level was equivalent between the groups at all postoperative end points. There was no observed difference in perioperative blood loss observed between the two groups.Conclusion: Perioperative ketorolac has the same effect on postoperative pain as determined by VAS as placebo. The use of ketorolac at the 30-mg dose cannot be recommended for better pain control for patients undergoing first-trimester pregnancy termination by suction curettage. The only positive effect of the use of ketorolac compared to placebo was a reduction in the use of acetaminophen. Ketorolac use does not appear to change blood loss in the operating room or through postoperative day 1 compared to placebo.

Ethinyl estradiol and levonorgestrel pharmacokinetics with a low-dose transdermal contraceptive delivery system, AG200-15: a randomized controlled trial - Corrected Proof

David F. Archer, Frank Z. Stanczyk, Arkady Rubin, Marie Foegh — 2011-12-02

Abstract: Background: This study evaluated the ethinyl estradiol (EE) and levonorgestrel (LNG) pharmacokinetic profiles of AG200-15, a transdermal contraceptive delivery system, compared with a combination oral contraceptive (COC) containing EE 35 mcg and norgestimate 250 mcg.Study design: A Phase 1, open-label, single-center study in 36 healthy women was conducted over three cycles with a randomized crossover design. After a run-in cycle of 21 days on and 7 days off with AG200-15, participants were randomized to receive one of two treatments: a 21/7-day cycle of AG200-15 either followed or preceded by one cycle of the COC. This trial is registered on ClinicalTrials.gov under the identifier NCT01243580.Results: During the third week of AG200-15 use, mean (±standard deviation) maximum serum concentration (Cmax), area under the curve0–168 h and steady-state concentration (Css48–168 h) for EE were 51.3±17.3 pg/mL, 6.26±2.46 ng h/mL and 35.7±14.5 pg/mL, respectively; for LNG, the corresponding values were 2400±1140 pg/mL, 317±159 ng h/mL and 1847±930 pg/mL, respectively. The AG200-15 EE Cmax was approximately 60% lower and the EE Css was 15%–20% lower than those obtained with the COC. The calculated daily dose of AG200-15 was equivalent to a 30-mcg EE COC. The most common adverse events (AEs; >10%) in the AG200-15 group were headache, nausea and application-site irritation. All drug-related AEs were mild, and no serious AEs were reported.Conclusions: EE and LNG daily exposure during AG200-15 treatment was within the range reported for a low-dose COC. The daily EE dose with AG 200-15 was equivalent to a 30-mcg COC and was safe and well tolerated.

Relation of androgen receptor sensitivity and mood to sexual desire in hormonal contraception users - Corrected Proof

2011-12-02

Abstract: Background: Since very little research in this field is available, this study aims to assess the role of psychosexual, relationship, hormonal and genetic measures in the sexual desire of users of three hormonal contraceptive products [low-dose combined oral contraceptive (20 mcg ethinylestradiol/150 mcg desogestrel), progestin-only pill (75 mcg desogestrel) and vaginal ring (daily dose of 15 mcg ethinylestradiol/120 mcg etonogestrel)].Study Design: Fifty-five couples were randomized over three groups in which the women consecutively used each product during 3 months. Both partners repeatedly filled out questionnaires on solitary and dyadic sexual desire (desire to behave sexually by oneself or towards a partner). Total and free testosterone, sex hormone binding globulin and a genetic marker of androgen receptor sensitivity [cytosine–adenine–guanine (CAG) repeat length] were assessed on blood samples of the female partners.Results: Sexual desire was higher in women with either short or long CAG repeats (solitary, p=.004; dyadic, p=.008). Desire levels were higher during vaginal ring use (solitary, p=.018; dyadic, p=.007). The woman's mood was found to impact her dyadic sexual desire (p<.001); this scale was also strongly associated with the male partner's dyadic sexual desire (p<.001).Conclusions: The current study found evidence for a role of androgen receptor sensitivity and mood in the sexual desire of hormonal contraceptive users.

Contraceptive sterilization among married adults: national data on who chooses vasectomy and tubal sterilization - Corrected Proof

2011-12-02

Abstract: Background: Vasectomy has been found to be a highly cost-effective contraceptive method. For couples, tubal sterilization and vasectomy have the same result, but the two methods are used by different segments of the population.Study design: We conducted an analysis of data from male and female samples of the 2006–2008 National Survey of Family Growth, nationally representative samples of men and women in the United States aged 15–44 years.Results: Among married men, 13.1% reported vasectomies (95% confidence interval 10.4%–16.3%), compared to 21.1% (17.8%–24.9%) of married women who reported tubal sterilizations. Men with higher education and income had greater prevalence of vasectomy than those less educated, while women with lower education and income had the highest prevalence of tubal sterilization.Conclusions: Efforts to promote vasectomy use need to understand the reasons behind these differences. Increasing the availability and use of vasectomy will require education about its benefits.

Magnetic resonance imaging and gynecological devices - Corrected Proof

2011-12-02

Abstract: Background: Performing magnetic resonance imaging (MRI) on women with gynecological devices is a completely accepted practice. The goal of our review is to assess how safe it is to perform MRI on women using contraceptive implants or devices.Study Design: Literature review, searching in PubMed-Medline/Ovid for the following keywords: magnetic resonance imaging, intrauterine devices, Implanon® and Essure ®.Results: Though plastic devices do not represent a contraindication to the use of the technique, those including metallic components have been submitted to several tests, after which they were classified as MR Conditional (devices presenting no risks in MR-specific environments) by the Food and Drug Administration. Thus, the use of MRI can be safely advised to women with this type of device as long as the magnetic resonance equipment is ≤3.0 T.Conclusions: Presently, there is no scientific evidence that contraindicates performing MRI on women with any kind of gynecological device. Therefore, this procedure is safe as long as it is performed under previously tested conditions.

When did family planning become a risky proposition? - Corrected Proof

Jon O'Brien — 2011-11-14

In “Title X: A Proud Past, An Uncertain Future,” Coleman and Jones describe a robust family planning network that was created and maintained in a politically divisive environment. The legislators who crafted Title X 40 years ago kept the focus on their constituents and were able to create centers where “no one is turned away.” This is a true safety net—policy that delivers on the promise of bringing family planning to all who need it and want it. If they could do it then, why has contraception become such a divisive issue today?

A successful approach to long-acting contraceptive implants in primary care - Corrected Proof

L. Anne Jeffreys, Andrew L. Clark — 2011-11-14

Abstract: Background: Subdermal implants of etonogestrol are an effective method of contraception but have a high discontinuation rate often due to irregular uterine bleeding. Implants are often placed in specialist environments away from the woman's usual primary health care provider in the UK.Study Design: The aim of the study was to assess the rate of (and reasons for) discontinuation of the implant using a two-stage procedure for device placement in primary care.Results: One hundred thirty-one implants were placed between July 2005 and September 2009. Follow-up was complete at 9th November 2010, with the exception of seven women who left the practice area. The median age at placement was 24.0 years (interquartile range, 18.0–32.8 years). At 1 year, 90% of implants were still in place. Twelve implants (10%) were removed: seven were for irregular bleeding, three were for weight gain and one each was for acne and wishing to conceive. Over the next year, a further nine were removed (three for irregular bleeding, one to conceive and one each for acne, low mood, abdominal pain and amenorrhea). Two more were removed at 25 and 27 months (both for irregular bleeding), with no further implants removed thereafter other than to exchange for a new implant at 36 months. There were no pregnancies in 3595 women-months.Conclusions: Etonogestrel implants can be safely and successfully inserted in primary care by well-trained users. It is possible for well-trained users to achieve a very high device retention rate in primary care compared with published data from other practice settings.

Evaluation of oxidative stress after treatment with low estrogen contraceptive either alone or associated with specific antioxidant therapy - Corrected Proof

Annarosa Finco, Gianni Belcaro, Maria Rosaria Cesarone — 2011-11-14

Abstract: Background: The aim of the study is to analyze the effect of low estrogen contraceptives (OC) on oxidative stress (OS) and concomitantly also the changes produced by different treatments using physiological modulators (PMs) with antioxidant action.Study Design: Sixty-four female volunteers using a low estrogen OC regimen were analyzed for their OS status through the reactive oxygen metabolites-derived compounds (d-ROMs) test, during 5 different cycles (Cycle I to V). Three experiments were performed.Results: In the first experiment (Cycle I), OS showed almost a constant 50% increase in all the determinations. In the second experiment (Cycles II and III), the participants were divided into two groups and treated double-blind with a placebo or with a PM (MF Templar®) that significantly reduced OS, on average by 69%, while the placebo had no effect. In the third experiment (Cycles IV and V), the placebo group was divided into three subgroups, A, B, C and treated, respectively, with MF Templar®, green tea containing the same amount of catechins present in MF Templar® or with MF Templar® devoid of catechins. Only the complete product, MF Templar®, was able to reduce OS levels, on average by 70%.Conclusion: We conclude that to control the OS generated by OC, specific types of PMs are needed. In particular MF Templar® was able to induce a significant reduction of OS levels.

The effect of obesity and low-dose oral contraceptives on carbohydrate and lipid metabolism - Corrected Proof

Anitra Beasley, Christopher Estes, Jacqueline Guerrero, Carolyn Westhoff — 2011-11-14

Abstract: Background: Combination oral contraceptives (OCs) have little effect on carbohydrate and lipid metabolism in normal-weight women. Based on lack of change in intermediate markers, as well as results of epidemiologic studies, low-dose OCs do not increase the risk of diabetes or cardiovascular disease. Obesity is a risk factor for impaired glucose tolerance, diabetes and coronary artery disease, and most previous OC studies excluded these women; thus, we have limited information about carbohydrate and lipid metabolism in obese OC users.Study Design: This study compared changes in carbohydrate and lipid parameters in 71 normal-weight and 38 obese women initiating the OC. Women were randomized to two pills: 30 mcg ethinyl estradiol (EE)/150 mcg levonorgestrel (LNG) or 20 mcg EE/100 mcg LNG. Participants underwent baseline and cycle-3 measurements of fasting serum glucose; insulin; triglycerides and total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol.Results: Normal-weight and obese participants experienced similar changes in mean glucose, insulin and log homeostatic model assessment, as well as similar changes in total cholesterol, HDL and triglycerides; however, change in mean LDL (−4.9±20.6 mg/dL vs. +3.8±17.3 mg/dL) was different between the obese and normal-weight groups, respectively. Among the obese participants, change in glucose was marginally greater with the higher dose pill (p=.06); otherwise, changes between the body mass index groups were not modified by pill dose.Conclusions: Obesity had little effect on any OC-induced changes in carbohydrate or lipid metabolism except for a borderline adverse interaction between obesity and OC dose with respect to fasting glucose and a positive interaction between obesity and OC use with respect to LDL cholesterol.

Self-administration of subcutaneous depot medroxyprogesterone acetate for contraception: feasibility and acceptability - Corrected Proof

Sujatha Prabhakaran, Ashley Sweet — 2011-11-14

Abstract: Background: The objectives of the study were to assess feasibility, continuation rates and patient satisfaction with self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA-SC).Materials and Methods: The study included 50 DMPA-seeking women between the ages of 18 and 49 years enrolled at two Florida Planned Parenthood health centers. Participants were taught self-injection during their initial study visit and, upon proficiency, self-injected one dose in clinic. Participants then injected a series of three more doses outside the health center over 9 months. Continuation rates, feasibility and acceptability were determined by analysis of four postinjection surveys.Results: Continuation of DMPA-SC at injection 4 was 74% (95% confidence interval 62%–86%). Overall, survey responses from the three at-home injections indicated the method to be convenient (95%), easy (87%) and recommendable to others (94%). Twenty percent of injections were met with difficulty, most commonly cited as plunger resistance. No pregnancies occurred in study.Conclusions: Continuation was high with DMPA-SC self-injection. Participants reported injection to be easy and convenient and are likely to recommend self-administration to other women. Device issues are one potential deterrent.

In vitro cytotoxicity of Cu2+, Zn2+, Ag+ and their mixtures on primary human endometrial epithelial cells - Corrected Proof

Jing Wu, Luyao Wang, Jing He, Changhong Zhu — 2011-11-14

Abstract: Background: To avoid the inherent disadvantages of copper-containing intrauterine device (Cu-IUD) induced by free Cu2+, two other well-performing metal ions, namely, Ag+, with long-effective antimicrobial properties, and Zn2+, as an essential trace element, are being considered for use in the future as multifunctional IUDs. The purpose of this study was to assess the cytotoxicity of these metal ions and their mixtures on primary human endometrial epithelial cells (HEECs) cultured in vitro and to provide several choices of alternative potential materials for creating excellent IUDs in the future.Study Design: With the use of 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide-formazan (MTT-f) production, the cytotoxic effects of single metal ions (Cu2+, Zn2+, Ag+) on HEECs after exposure for 24, 48 or 72 h were investigated, and the synergistic and antagonistic effects of two ions applied simultaneously were also assessed.Results: The cytotoxicity of the metal ions on HEECs ranked as follows: Ag+>Cu2+>Zn2+. All combinations of those tested indicated that the Cu2++Zn2+ system exhibited an antagonistic effect absolutely, the Zn2++Ag+ system showed both antagonism and slight synergism, and asynergistic effect was observed in the Cu2++Ag+ system.Conclusion: From a perspective of favorable biocompatibility, Zn2+ and the Cu2++Zn2+ mixture showed evidence of potential components for use in future IUDs. Although having strong cytotoxicity, Ag+ with its low release rate and broad-spectrum antibiotic activity may also be considered. The study also demonstrated the relative stability of Cu2+ as a classic material of IUD.

Music for surgical abortion care study: a randomized controlled pilot study - Corrected Proof

2011-11-14

Abstract: Background: The study objective was to explore the effect of music as an adjunct to local anesthesia on pain and anxiety during first-trimester surgical abortion. Secondary outcomes included patient satisfaction and coping.Study Design: We conducted a randomized controlled pilot study of 26 women comparing music and local anesthesia to local anesthesia alone. We assessed pain, anxiety and coping with 11-point verbal numerical scales. Patient satisfaction was measured via a 4-point Likert scale.Results: In the music group, we noted a trend toward a faster decline in anxiety postprocedure (p=.065). The music group reported better coping than the control group (mean±S.D., 8.5±2.3 and 6.2±2.8, respectively; p<.05). Both groups reported similarly high satisfaction scores. There were no group differences in pain.Conclusions: Music as an adjunct to local anesthesia during surgical abortion is associated with a trend toward less anxiety postprocedure and better coping while maintaining high patient satisfaction. Music does not appear to affect abortion pain.