Contraception - Articles in Press

Induction of fetal demise before abortion: SFP Guideline 20101, Release date January 2010 - Corrected Proof

Susan Higginbotham — 2010-03-15

Abstract: For decades, the induction of fetal demise has been used before both surgical and medical second-trimester abortion. Intracardiac potassium chloride and intrafetal or intra-amniotic digoxin injections are the pharmacologic agents used most often to induce fetal demise. In the last several years, induction of fetal demise has become more common before second-trimester abortion. The only randomized, placebo-controlled trial of induced fetal demise before surgical abortion used a 1 mg injection of intra-amniotic digoxin before surgical abortion at 20–23 weeks' gestation and found no difference in procedure duration, difficulty, estimated blood loss, pain scores or complications between groups. Inducing demise before induction terminations at near viable gestational ages to avoid signs of life at delivery is practiced widely. The role of inducing demise before dilation and evacuation (D&E) remains unclear, except for legal considerations in the United States when an intact delivery is intended. There is a discrepancy between the one published randomized trial that used 1 mg intra-amniotic digoxin that showed no improvement in D&E outcomes and observational studies using different routes, doses and pre-abortion intervals that have made claims for its use. Additional randomized trials might provide clearer evidence upon which to make further recommendations about any role of inducing demise before surgical abortion. At the current time, the Society of Family Planning recommends that pharmacokinetic studies followed by randomized controlled trials be conducted to assess the safety and efficacy of feticidal agents to improve abortion safety.

Follicular development and ovulation in extremely obese women receiving depo-medroxyprogesterone acetate subcutaneously - Corrected Proof

2010-03-11

Abstract: Background: Subcutaneous depo-medroxyprogesterone acetate (DMPA-SC) has not been studied in the extremely obese population (BMI ≥40 kg/m2). The purpose of this 26-week prospective experimental study was to determine incidence of ovulation and follicular development among women with Class 1, 2 and 3 obesity after receiving DMPA-SC.Methods: Five normal-weight, five Class 1-2 obese, and five Class 3 obese women received subcutaneous injections of 104 mg DMPA-SC at baseline and 12 weeks later. Weekly progesterone levels, bimonthly estradiol (E2), and monthly medroxyprogesterone acetate (MPA) levels were measured by immunoassay methods for a total of 26 weeks in each subject.Results: Ovulation did not occur in any subject more than 1 week after the first injection. There was large intersubject and intrasubject variability in E2 levels, and fluctuating E2 levels were more frequent among obese women than normal-weight women. Median MPA levels remained above the level needed to prevent ovulation but, compared with normal-weight subjects, were lower among Class 1-2 obese and lowest among Class 3 obese subjects.Conclusion: Fluctuating E2 levels reflective of follicular development occurred more often among Class 1, 2 and 3 obese women than normal-weight women after DMPA-SC injections. Median MPA levels were consistently lowest among Class 3 obese women but remained above the level needed to inhibit ovulation. Further studies should more fully address the pharmacokinetics of DMPA-SC in extremely obese women.

Complication rates and utility of intravenous access for surgical abortion procedures from 12 to 18 weeks of gestation - Corrected Proof

Christina M. Racek, Beatrice A. Chen, Mitchell D. Creinin — 2010-03-11

Abstract: Background: The study was conducted to compare need for intravenous (IV) access and the immediate complication rate in women having an outpatient surgical abortion at 12-1/7 to 15-6/7 weeks gestation (12–15+ weeks) versus 16-0/7 to 18-0/7 weeks of gestation (16–18 weeks).Study Design: This retrospective cohort study included 1503 women who underwent a surgical abortion (dilation and curettage or dilation and evacuation) in a free-standing outpatient clinic from April 1, 2001, to April 1, 2008. The primary outcome was IV access used for fluids or emergent medications.Results: Of the procedures, 1216 (81%) were at 12–15+ weeks and 287 (19%) were 16–18 weeks. The incidence of immediate complications that could require IV access was 1.1% and 3.8%, respectively (p=.001). However, most were cervical lacerations that did not require IV fluids or treatments. Major immediate complications (uterine perforation or hospital transfer) occurred in 0.3% and 0.7%, respectively (p=.32). Overall, there were 7 (0.5%, 95% CI 0.1–0.8%) women who required access because of a complication. There were no cases for which IV access was needed emergently and was unable to be obtained.Conclusions: IV access is rarely medically needed due to an immediate complication from surgical abortion at 12 to 18 weeks gestation. Major complication rates for such procedures are very low. Routine use of IV access at 16–18 weeks solely because of gestational age is not warranted.

Combined oral contraceptive use among breastfeeding women: a systematic review - Corrected Proof

Nathalie Kapp, Kathryn M. Curtis — 2010-03-11

Abstract: Background: Postpartum women need effective contraception, but using hormonal contraceptives may affect breastfeeding performance and infant health outcomes.Study design: We searched the MEDLINE and Cochrane databases for all articles published through May 2009 for primary research studies that investigated clinical outcomes among breastfeeding women who used hormonal contraception or their infants.Results: Three randomized controlled trials reported decreased mean duration of breastfeeding and higher rates of supplemental feeding among combined oral contraceptive (COC) users than among nonusers, while one multicountry trial found no differences in these parameters. Only one study demonstrated lower average weights during the first year of life for infants whose mothers used COCs while breastfeeding. None of the eight studies, four of which were observational, included in this review documented adverse infant health outcomes.Conclusions: Limited evidence demonstrates an inconsistent effect of COC on breastfeeding duration and success. The evidence is inadequate to determine whether a mother's use of these drugs affects breastfeeding duration or the infant's health.

Safety of contraceptive use among women with peripartum cardiomyopathy: a systematic review - Corrected Proof

Naomi K. Tepper, Melissa E. Paulen, Polly A. Marchbanks, Kathryn M. Curtis — 2010-03-11

Abstract: Study design: Women with peripartum cardiomyopathy (PPCM) have significant health risks during subsequent pregnancies and therefore have a critical need for safe and effective contraception. This systematic review examines evidence regarding the safety of contraceptive use among women with PPCM.Methods: We searched the PubMed database for all primary research articles published through February 2009 that addressed the safety of any contraceptive method among women with PPCM or other cardiomyopathy of any type.Results: Of 110 articles that addressed contraceptive safety among women with cardiac disease, three met our inclusion criteria. In these three studies, which included a total of five women with cardiomyopathy, though not specifically PPCM, cases of hypertension, transient ischemic attack (TIA), thromboembolism or heart failure were found among women with cardiac disease who used hormonal methods of contraception including combined oral contraceptives, progestin-only pills and depot medroxyprogesterone acetate. None of the studies reported any cases of cardiovascular complications or infective endocarditis among women with cardiac disease who used intrauterine devices (IUDs).Conclusions: We found no data concerning the safety of contraceptive use among women with PPCM, though we did find limited evidence of hypertension, TIA, thromboembolism and heart failure among women with cardiac disease who used hormonal methods of contraception. None of the studies reported any cases of cardiovascular complications or infective endocarditis among women with cardiac disease who used IUDs.

Improving hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic sterilization - Corrected Proof

Maryam Guiahi, Kara N. Goldman, Margaret M. McElhinney, Christopher G. Olson — 2010-03-08

Abstract: Background: Given the need for a 90-day post-Essure hysterosalpingogram (HSG) to confirm proper tubal placement and occlusion, we examined the impact of dedicating a staff nurse to schedule HSG appointments, call with appointment reminders and track HSG compliance for patients who had Essure.Study design: We performed a retrospective chart review for patients who underwent Essure sterilization between October 2003 and January 2009. We compared rates of HSG compliance and confirmed tubal occlusion for patients before February 2008 with rates after the protocol change occurred.Results: Seventy-eight percent of preintervention patients were compliant with at least one HSG following Essure placement compared to 90.9% in the post-intervention group (p value=.033). Tubal occlusion was confirmed by postprocedure HSGs for 123/173 patients (71.1%) in the preintervention group and 48/55 patients (87.3%) in the postintervention group. Patients followed by our staff after our protocol change were more likely to undergo post-Essure compliance (Odds ratio= 2.7, confidence interval = 1.2–7.1, p=.01).Conclusion: Dedicating a staff nurse to track patients' HSG follow-up as a multicheck system resulted in an improvement in HSG compliance and rates of confirmed tubal placement and occlusion.

Reframing unintended pregnancy prevention: a public health model - Corrected Proof

Diana Taylor, Amy Levi, Katherine Simmonds — 2010-03-08

The goal of reducing unintended pregnancy was identified in Healthy People 2000 , but the measures and objectives created to reach this goal have often focused solely on increasing access to contraception. While increasing access to contraception is a vitally important tool, it does not sufficiently address the problem of unintended pregnancy. Clarifying the roles and responsibilities of primary care clinicians and providing them with state-of-the-art tools and training in this aspect of reproductive health care is equally important for solving this public health challenge. In order to achieve this goal, we need to establish culturally appropriate evidence- and competency-based clinical guidelines for the prevention and management of unintended pregnancy that can be integrated into primary care and the broader health system and that are built on a comprehensive public health framework for pregnancy prevention that specifies the essential competencies required of all members of the health care team.

Length of the endometrial cavity as measured by uterine sounding and ultrasonography in women of different parities - Corrected Proof

2010-03-02

Abstract: Background: In view of current controversies regarding the need for new, shorter intrauterine devices (IUDs) that would reduce expulsion rates in nulligravida, endometrial cavity length was measured in women of different parities using uterine sounding and ultrasonography.Study Design: A cross-sectional descriptive study was performed including 570 women of 17–52 years of age, 260 of whom were nulligravida and 310 parous.Results: The difference in mean length between measurements taken by uterine sounding and ultrasonography was 0.28 cm. Mean endometrial cavity length was 3.84±0.03 cm (mean±S.E.M.) in nulligravida and 4.25±0.03 cm in parous women according to uterine sounding (p 3.6 cm, the length of the most common IUDs, the TCu380A and the levonorgestrel-releasing intrauterine system. Therefore, the issue appears controversial for developing new, shorter IUDs, since current models fit most women, including nulligravida, albeit one third of the women of our sample showed endometrial length shorter than 3.2 cm.

Response to Letter to the Editor - Corrected Proof

David A. Grimes — 2010-03-02

Dr. Creinin and I agree on the importance of highly effective, long-acting methods of contraception that reduce or eliminate the need for compliance. My definition of “forgettable” contraception attempted to make objective the subjective term proposed by Guillebaud, Kubba and others in the UK.

Comparison of local signs and symptoms at the site of insertion of Implanon® and Jadelle® contraceptive implants in two countries - Corrected Proof

2010-03-02

Abstract: Objectives: The study was conducted to assess the prevalence of local signs and symptoms at the insertion site in the arm of two groups of users of either two levonorgestrel (LNG)-releasing rods or one etonogestrel (ENG)-releasing contraceptive rod in Brazil and Dominican Republic.Study Design: A total of 226 and 233 women were enrolled in the ENG group and the LNG group, respectively. Local signs were evaluated and women were questioned regarding complaints related to the insertion site at 3, 6, 12, 24 and 36 months after insertion.Results: Pain and other symptoms (mostly pruritus) were the most frequently reported complaints (∼20%) and were observed in a similar proportion among both Implanon and Jadelle users; paresthesia was less frequently reported. Hyperpigmentation was threefold higher among users of Jadelle than Implanon users (p<.0001) and was more prevalent among nonwhite users. All symptoms and signs were reported much more frequently by Dominican women. The logistic regression model adjusted by race and body mass index (kg/m2) showed that users of Implanon and white women presented lower risk of hyperpigmentation [odds ratio (OR) 0.26, 95% confidence interval (CI) 0.14–0.48; OR 0.34, 95% CI 0.14–0.81, respectively].Conclusions: Although information relating to local symptoms and signs at the implant site should be provided to current and potential users as a component of good quality of care, we do not recommend evaluation of the insertion site at every visit in women with no complaints.

Double-blind, randomized, placebo-controlled study on the effect of misoprostol on ease of consecutive insertion of the levonorgestrel-releasing intrauterine system - Corrected Proof

2010-03-02

Abstract: Background: Misoprostol has been studied intensively to produce cervical dilatation. To date, no studies have evaluated the effectiveness, safety or acceptability of this treatment for repeat intrauterine device insertions.Study Design: This study was a randomized, double-blind, placebo-controlled trial on the consecutive use of the levonorgestrel-releasing intrauterine system (LNG-IUS). Women who had used their first LNG-IUS for 4 years and 3 to 9 months and opted for an immediate replacement with a second LNG-IUS received a single sublingual dose of 400 mcg misoprostol or placebo 3 h prior to the LNG-IUS insertion.Results: The proportion of easy insertions as judged by the investigator was 93% (40/43) in subjects randomized to misoprostol and 91% (42/46) in the placebo group (p=1.0 for the difference of proportions). No or mild pain at insertion was reported by 37% and 35% of subjects in the misoprostol and placebo groups, respectively. However, adverse events related to the study drug were more common in the misoprostol group.Conclusion: Sublingual misoprostol did not have a significant effect on the ease of insertion in subjects having a repeat insertion of the LNG-IUS.

Endocrinological, metabolic and clinical features of treatment with oral contraceptive formulation containing ethinylestradiol plus chlormadinone acetate in nonobese women with polycystic ovary syndrome - Corrected Proof

2010-03-02

Abstract: Background: Chlormadinone acetate (CMA) is a progestin compound similar to progesterone, with antiandrogenic properties. In healthy eumenorrheic women, it was demonstrated that the monophasic estroprogestin formulation containing CMA (2 mg) plus ethinyl estradiol (EE) (30 mcg) (EE30+CMA) is efficacious both in reducing hyperandrogenic symptoms, fat mass and in improving lipoprotein panel, without changes in insulin-glucose metabolism. These metabolic properties are important for women affected by polycystic ovary syndrome (PCOS) in whom there is a predisposition to insulin resistance.Study Design: We studied whether in young nonobese women with PCOS (15 subjects, EE30+CMA-PCOS group) a six-cycle treatment with EE30+CMA can reduce androgen levels, androgen bioavailability and the score of hirsutism and acne, and modify glucose-insulin metabolism evaluated by the oral glucose tolerance test and the body composition evaluated by bio-impedenziometry. These parameters were evaluated before (first visit) and during the sixth cycle of EE30+CMA (second visit). All the results were compared with those of a matched-age-group of nonobese PCOS women (15 subjects, no OC-PCOS group) evaluated before (first visit) and after six menstrual cycles in which they did not use any drug or oral contraceptive (second visit).Results: In the EE30+CMA-PCOS group women, androgen levels and bioavailability, hirsutism and acne score were significantly lower at the second than at the first visit, whereas they did not change in no OC-PCOS group. At the second visit, in both groups, glucose-insulin metabolism and body composition parameters were not affected.Conclusions: A six-cycle treatment with EE30+CMA is efficacious in nonobese PCOS women to improve hyperandrogenic symptoms, without negative interferences both on body composition and on insulin-glucose metabolism.

Erratum to “The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trial” [Contraception 2009;80:133–41] - Corrected Proof

2010-02-22

In the above article, the authors detected some errors in . In , the 7th and 8th year rates with 95% confidence limits of “Other medical removals” for the frameless IUD should read 2.2 (1.5–3.3) and 2.5 (1.6–3.7), respectively, and for the TCu380A it should be 1.7 (1.2–2.6) and 2.5 (1.7–3.6), respectively, as shown in the corrected . Also in , the overall discontinuation rate of the frameless device for the 7th year should read 41 (38–43).

Forgettable contraception - Corrected Proof

Mitchell D. Creinin — 2010-02-22

I thought the commentary by Dr. Grimes in the December 2009 issue of Contraception was both intuitive and timely . In his commentary, Dr. Grimes argues that the term “long-acting reversible contraception” (LARC) should be replaced by “forgettable contraception.” Dr. Grimes defines the latter term as “a method that requires user attention no more often than every 3 years.” Accordingly, male and female sterilization, intrauterine contraceptives and contraceptive implants meet the criteria set forth to be considered forgettable contraception. In comparison, LARC methods, defined as methods that require less than monthly administration, do not include sterilization but do include some injectable hormonal contraceptives such as depo-medroxyprogesterone acetate and norethindrone enanthate. Dr. Grimes outlines the five principal factors that determine contraceptive effectiveness as efficacy, compliance, continuation, fecundity and coital frequency/timing. Accordingly, Dr. Grimes argues correctly that injectable contraceptives do not truly merit such high distinction as “first tier” contraceptives because of poor continuation.

Use of the Mirena™ LNG-IUS and Paragard™ CuT380A intrauterine devices in nulliparous women: Release date 15 December 2009 SFP Guideline 20092 - Corrected Proof

2010-02-22

Abstract: Two intrauterine devices (IUDs) are available in the United States, the levonorgestrel-bearing intrauterine system (Mirena™) and the copper-bearing T380A (Paragard™). These devices have very low typical-use failure rates but are used by only a minority of women. In particular, there is concern about their use in nulliparous women. We review the available data to address common concerns about using IUDs in this population and show that nulliparous women desiring effective contraception should be considered candidates for IUDs.

Long-term efficacy and safety of a monophasic combined oral contraceptive containing 0.02 mg ethinylestradiol and 2 mg chlormadinone acetate administered in a 24/4-day regimen - Corrected Proof

2010-02-22

Abstract: Objective: This study was conducted to assess the long-term efficacy and safety of a low-dose monophasic combined oral contraceptive (COC) containing 0.02 mg ethinylestradiol (EE) and 2 mg chlormadinone acetate (CMA) in a novel regimen administered daily for 24 days followed by a 4-day placebo interval.Study Design: In this multicenter, uncontrolled, Phase III trial, 1665 subjects took the COC 0.02 mg EE/2 mg CMA for up to 21 cycles. The overall Pearl Index was the primary end point; cycle control, safety, effect on acne and seborrhea, and changes in body weight and libido were secondary end points.Results: Contraceptive efficacy was analyzed for 1653 subjects completing 21,495 cycles. Six pregnancies occurred during trial duration with one attributable to method failure. The overall Pearl Index for the first year of use was 0.33 (95% confidence interval, 0.09–0.85). The mean number of bleeding/spotting days during six 90-day reference periods (RPs) decreased from 17.0 (RP 1) to 11.7 (RP 6), and the number of bleeding episodes per RP decreased from 3.8 (RP 1) to 2.7 (RP 6). Among subjects who presented with acne at the baseline visit, a decrease of papules/pustules and comedones was observed during the course of the trial. The most common “at least possibly related” adverse events were headache, breast discomfort and nausea. The tolerability and well-being was reported as being excellent or good in the majority of trial subjects (84.6% and 80.2%, respectively).Conclusions: The low-dose COC 0.02 mg EE/2 mg CMA administered daily for 24 days followed by a 4-day placebo interval provides high contraceptive efficacy combined with an adequate cycle control and safety profile, beneficial effects on acne, and is well tolerated.

Pharmacist-administered subcutaneous depot medroxyprogesterone acetate: a pilot randomized controlled trial - Corrected Proof

Carla Picardo, Stefanie Ferreri — 2010-02-22

Abstract: Background: The objectives of this study were to assess the feasibility of administering subcutaneous depot medroxyprogesterone acetate (DMPA-SC) in a pharmacy setting and assess patient satisfaction.Study Design: Fifty women, at least 18 years of age, presenting to a family planning clinic to initiate, continue or restart any form of DMPA were randomized to receive two subsequent injections at a nearby pharmacy by trained pharmacists or at the clinic. Women completed two follow-up surveys to rate their satisfaction with DMPA-SC and their clinic/pharmacy experiences.Results: The relative risk of returning and receiving a second DMPA-SC injection of women randomized to the pharmacy compared with those randomized to the clinic was 0.73 (95% CI 0.42–1.27). The relative risk of returning and receiving a third DMPA-SC injection was 0.75 (95% CI 0.39–1.46). Most women found the pharmacy setting convenient (70%), private (100%), the providers respectful (100%) and were satisfied with DMPA-SC and the pharmacy as a clinical site (≥89%). No significant difference in patient satisfaction with location, convenience, privacy, and respect from providers was found between study groups (p>.05), nor were there significant differences in attitudes or satisfaction among women between their two follow-up injections.Conclusion: Administration of DMPA-SC by pharmacists in a pharmacy setting is feasible. Continuation rates and patient satisfaction with DMPA-SC and the pharmacy setting were comparable to those who received DMPA-SC in a family planning clinic.

Effect of etonogestrel implant on serum lipids, liver function tests and hemoglobin levels - Corrected Proof

Berna Dilbaz, Ozlem Ozdegirmenci, Eray Caliskan, Serdar Dilbaz, Ali Haberal — 2010-02-22

Abstract: Background: This study aimed to assess the possible effects of etonogestrel implant (Implanon®, Organon, Oss, The Netherlands) on total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Hb levels in a sample of Turkish population.Study design: Healthy women of childbearing potential who had applied to our Family Planning Clinic for a contraceptive method and had chosen to have an Implanon insertion after thorough counseling about all family planning methods and screening for eligibility for Implanon use were enrolled in the study. Serum concentrations of TC, TG, HDL-C, LDL-C, AST, ALT and Hb levels were tested before and at 3 and 6 months after insertion. Baseline mean parameters were compared with mean parameters at 3 and 6 months for statistical significance using paired-samples t test.Results: Eighty-two women eligible for the study were included. Mean age of the patients was 27.5±4.8 years. When compared to the baseline values, there was a statistically significant decrease in the TC (p<.001), HDL-C (p<.001) and TG (p=.006) at the end of the third month, while there was a significant increase in Hb values (p=.01). The decrease in TC (p=.001) and HDL-C (p<.001) and increase in Hb value (p=.03) persisted by the end of sixth month while the decrease in TG was transient. A statistically significant increase in mean ALT level was observed at 6 months (p=.03).Conclusion: The effect of Implanon on liver functions and lipid metabolism does not lead to unhealthy alterations. Increase in Hb can be attributed to the high frequency of amenorrhea in patients.

Benefits of using a digital video disk for providing information about abortion to women requesting termination of pregnancy - Corrected Proof

Rebecca Powell-Jackson, Anna Glasier, Sharon T. Cameron — 2010-02-22

Abstract: Background: A patient information digital video disk (DVD) on abortion was produced for use in a hospital abortion service (Scotland) for women requesting termination of pregnancy.Study Design: Self-administered anonymous surveys of patients and clinic staff (doctors and nurses), before and after introduction of the DVD, was conducted.Results: Questionnaires were completed by 106 patients before introduction of the DVD and by 100 patients and 20 staff following its introduction. Patient satisfaction (score out of 10) with information received was significantly higher following introduction of DVD (mean, 9.2 vs. 8.3, with and without DVD, respectively; p<.001). Women liked the DVD's clear explanations (65% responses, n=35), and staff felt women were better informed (56.6% responses, n=13) and that it liberated time to discuss specific concerns and contraception (26.1%, n=6).Conclusions: The DVD provided high-quality information for women requesting abortion and resulted in staff having more time to discuss patient concerns and contraception.

Pharmacokinetics of a combined oral contraceptive in obese and normal-weight women - Corrected Proof

2010-02-22

Abstract: Background: This study was conducted to compare oral contraceptive (OC) pharmacokinetics (PK) in normal-weight [body mass index (BMI) 19.0–24.9] and obese (BMI 30.0–39.9) women.Study Design: During the third week of the third cycle of OC use, we admitted 15 normal-weight and 15 obese women for collection of 12 venous specimens over 24 h. Using radioimmunoassay techniques, we measured levels of ethinyl estradiol (EE) and levonorgestrel (LNG). During the same cycle, women underwent twice-weekly sonography to assess ovarian follicular development and blood draws to measure endogenous estradiol (E2) and progesterone levels.Results: Obese women had a lower area under the curve (AUC; 1077.2 vs. 1413.7 pg⁎h/mL) and lower maximum values (85.7 vs. 129.5 pg/mL) for EE than normal-weight women (p=.04 and <0.01, respectively); EE trough levels were similar between BMI groups. The similar, but smaller, differences in their LNG levels for AUC and maximum values (Cmax) were not statistically significant. While peak values differed somewhat, the LNG trough levels were similar for obese and normal-weight women (2.6 and 2.5 ng/mL, respectively). Women with greater EE AUC had smaller follicular diameters (p=.05) and lower E2 levels (p=.04). While follicular diameters tended to be larger among obese women, these differences were not statistically significant.Conclusion: OC hormone peak levels are lower among obese women compared to normal-weight women, but their trough levels are similar. In this small study, the observed PK differences did not translate into more ovarian follicular activity among obese OC users.

Does bupivacaine in laparoscopic ports reduce postsurgery pain in tubal ligation by electrocoagulation? A randomized controlled trial - Corrected Proof

2010-02-11

Abstract: Background: Tubal ligation (TL) is the most popular method of permanent contraception. In order to reduce postoperative pain, different analgesic techniques have been proposed. The objective of this study was to compare the level of postoperative pain in patients submitted to TL with electrocoagulation, under general anesthesia, using bupivacaine infiltration vs. placebo in trocar ports.Study Design: Consecutive patients scheduled for laparoscopic TL were randomized by sequenced coded envelopes to receive bupivacaine 0.5% (n=29) or placebo (n=24). Pain was blindly assessed at 15 min, 30 min, 120 min and 14 h postoperatively, by verbal analogue scale (VAS). Standard pain medications (morphine, dipyrone and sodium diclofenac) were prescribed for the subjects and compared between groups.Results: No difference in pain assessment was found between bupivacaine and placebo groups at all times [median (25–75 quartiles)] (all p>.05): 15 min: 3 (1–6.3) vs. 4 (0–7); 30 min: 1.5 (0–4.3) vs. 2 (0–5); 2 h: 0 (0–0.5) vs. 0 (0–1); 14 h: 1 (0–4) vs. 0 (0–4); and for use of analgesics: dipyrone (g): 1 (0–1) vs. 1 (0–1); morphine (mg): 3 (0–3) vs. 3 (0–3.5); sodium diclofenac (mg): 0 (0–50) vs. 0 (0–50).Conclusion: The use of local injection of bupivacaine 0.5% in the trocar ports was not superior to placebo to reduce pain after laparoscopic TL with electrocoagulation under general anesthesia.

Delays in request for pregnancy termination: comparison of patients in the first and second trimesters - Corrected Proof

2010-02-11

Abstract: Background: Despite the availability of first trimester abortion services in urban settings, many women request abortion in the second trimester. We identified protective and risk factors associated with women who delay requesting abortions until the second trimester.Study Design: The study was a cross-sectional survey of 247 patients requesting surgical abortion at an urban family planning clinic. Survey and medical records data were analyzed for associations between 18 risk factors and incidence of second trimester request.Results: Thirty-two percent of subjects presented in the second trimester. Chi-square analyses revealed that first trimester participants were more often employed (p<.0001), privately insured (p=.01), or had previous abortions (p=.04). Second trimester patients were younger (p<.0001), more often primigravid (p=.04), experienced more difficulty financing the procedure (p<.0001) and finding a surgeon (p<.0001), traveled longer distances (p=.005), and more often feared the procedure (p=.03). Using multiple logistic regression, women requesting second trimester abortions were more likely to report: obstacles financing the abortion (OR 2.34, 95% CI 1.28–4.28); traveling long distances (OR 2.88, 95% CI 1.31-6.31); and fear (OR 2.45, 95% CI 1.17–5.17). These women were less often employed outside the home (OR 0.35, 95% CI 0.19–0.64).Conclusions: Physicians and advocates must strive to reduce abortion costs, increase access to trained surgeons, and allay women's fears of abortion procedures.

Effects of sex hormones in oral contraceptives on the female sexual function score: a study in German female medical students - Corrected Proof

2010-02-11

Abstract: Background: The survey was conducted to compare the influence of sex hormones in oral contraceptives (OCs) on female sexual function.Methods: One thousand eighty-six female German medical students completed an online-based questionnaire incorporating the Female Sexual Function Index (FSFI). Oral contraceptives used were classified into those containing androgenic or antiandrogenic progestins and by ethinylestradiol (EE) dosage (20 mcg, 30 mcg and >30 mcg). Female Sexual Function Index scores in women using OCs were compared to those in nonusers.Results: Seven hundred fifty-two of 1086 participating women used OCs. No statistically significant differences in FSFI scores were found among women using OCs containing androgenic or antiandrogenic progestins, nor were any seen between different EE dosages. In general, OC users had lower FSFI scores than nonusers.Conclusion: Female Sexual Function Index scores were negatively influenced by the use of OCs. However, the impact of an androgenic or antiandrogenic progestin content or different dosages of EE as modulating factors of female sexual function seems negligible.

Future abortion provision among US graduating obstetrics and gynecology residents, 2004 - Corrected Proof

2010-02-11

Abstract: Background: This study was conducted to identify characteristics associated with US obstetric and gynecology graduating residents' intention to provide pregnancy termination services in their clinical practice.Study Design: In this cross-sectional study, we surveyed all 1148 fourth-year residents in obstetrics and gynecology graduating from US training programs in 2004.Results: Of 494 respondents, 187 (39%) planned to perform elective abortions after residency. In multivariable analysis controlling for various factors, the following were independently associated with plans to perform pregnancy termination in the future: pre-residency intentions to provide pregnancy termination [odds ratio (OR), 10; 95% confidence interval (CI), 5.3–18.9; p<.001], performing more than 50 first-trimester abortions during residency (OR, 5.1; 95% CI, 1.3–19.6; p=.02) and plans to enter academic practice (OR, 2.5; 95% CI 1.1–6.2; p=.04).Conclusions: Intentions before residency to provide pregnancy termination services was the strongest predictor of future abortion provision.

Family planning: the essential link to achieving all eight Millennium Development Goals - Corrected Proof

Willard Cates — 2010-02-11

The International Conference on Family Planning, held in Kampala, Uganda, from November 15–18, 2009, drew over 1300 family planning researchers, program managers and health ministry officials from across the globe. This conference marked the reinvigoration of a global commitment to family planning.

Obstetrician-gynecologist experiences with abortion training: physician insights from a qualitative study - Corrected Proof

Lori Freedman, Uta Landy, Jody Steinauer — 2010-02-11

Abstract: Background: Abortion is one of the most contested, yet common surgical procedures in the United States and a required component of obstetrics and gynecology resident education. Approaches to abortion training are variable.Study Design: We conducted in-depth interviews with 30 physicians who had graduated 5–10 years prior from four US residency programs with routine abortion training. Interviews focused on their experiences with abortion during training and in practice.Results: Graduates' positive and negative experiences demonstrated that many valued teaching about the social issues surrounding abortion as well as training in surgical skills. Respondents found training rewarding when attending physicians openly discussed their personal commitment to abortion practice, respected differences of opinions about abortion and demonstrated high regard for abortion training. Some residents who opted out of surgical training for abortion valued partially participating in the rotation.Conclusions: Many physicians-in-training consider didactics related to the social context of care and respect for moral boundaries important components of abortion training.

A nonhormonal model for emergency contraception: prostaglandin synthesis inhibitor effects on luteal function and lifespan, a pilot study - Corrected Proof

Alison B. Edelman, Jeffrey T. Jensen, Jon D. Hennebold — 2010-02-11

Abstract: Objectives: The purpose of this study is to determine if the use of a specific prostaglandin endoperoxide-2 inhibitor will prevent luteal development in women.Study design: Ovulatory reproductive-aged women not using or needing hormonal contraception were prospectively followed for three menstrual cycles. Women were randomized into two groups using a crossover design [Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally) cycle; Group 2: control cycle, celecoxib cycle, placebo cycle]. Study drug was dosed daily until the onset of the next menses. Demographics, menstrual cycle length and twice-weekly progesterone (P) levels during the placebo and active drug cycles were recorded. End points included the change in luteal phase P levels and menstrual cycle length (days) during active drug exposure.Results: A total of 11 women completed the study (Group 1, n=7; Group 2, n=4). No demographic differences were found between groups [age, race, body mass index (BMI), control cycle length]. A comparison of the control and active drug cycles for all participants demonstrated a trend toward a longer menstrual cycle with active drug exposure [control, 27.2 days (SD, 2.4); study drug, 28.5 days (SD, 2.5), p=.09]. Five women had a delay in the rise of their luteal phase P levels, two women had lower peak P levels and two women had no elevation of luteal phase P levels during active drug cycle as compared to placebo cycle.Conclusion: Daily administration of a prostaglandin synthesis inhibitor may delay the timing of luteal events and, therefore, fertility in women. PTGS2 inhibitors may hold potential as an emergency contraceptive.

Postexposure prophylaxis for victims of sexual assault: treatments and attitudes of emergency department physicians - Corrected Proof

Arvind Bakhru, Julie B. Mallinger, Michelle C. Fox — 2010-02-11

Abstract: Background: Emergency departments (EDs) are the primary source of care for victims of sexual assault (SA). Provision of emergency contraception (EC) to these women has previously been noted to be sporadic. Completeness of care for victims of SA and the barriers to complete care are further investigated in this study.Study Design: All ED attending physicians in Maryland, Virginia and the District of Columbia were identified and contacted for participation; 35% completed the survey. Practice patterns were analyzed for the 67% of physicians who do not refer SA victims to other hospitals.Results: We found that 83% of physicians “always” or “usually” offer EC, but only half prescribe EC more than 48 h postassault. While most (89%) typically offer prophylaxis for STDs other than HIV, only 45% offer or counsel on HIV prophylaxis. Physician attitudes and hospital protocols were significant modifiers.Conclusion: Sexual assault victims are often not offered comprehensive care including prophylaxis against pregnancy and all STDs including HIV. Additional research is warranted to determine why physicians do not routinely offer HIV prophylaxis after SA.

A randomized controlled trial of the effect of advanced supply of emergency contraception in postpartum teens: a feasibility study - Corrected Proof

Courtney A. Schreiber, Sarah J. Ratcliffe, Kurt T. Barnhart — 2010-02-11

Abstract: Background: The study was conducted to test the feasibility of conducting a randomized controlled contraceptive trial in postpartum teens and to assess whether postpartum advanced supply of emergency contraception (EC) to teenaged mothers helps to prevent repeat pregnancies of close proximity.Study Design: We performed a randomized controlled trial of 50 postpartum teens at an urban academic medical center. Participants in the intervention arm received routine postpartum contraceptive care and advanced supply of one pack of EC pills with unlimited supply thereafter upon request. The routine care arm (RCA) received routine postpartum contraceptive care. We asked open-ended questions about how we might maximize study retention and implemented the participants' requests in both arms.Results: Our retention rate was 78%. There were three (13%) pregnancies out of 23 participants in the intervention arm and eight (30%) pregnancies out of 27 participants in the RCA. The risk of pregnancy occurring in the intervention arm was 0.57 times that of the RCA (95% CI 0.20–1.60; p=.23).Conclusions: A randomized controlled trial of postpartum teens to receive and not to receive advanced supply of EC is both feasible and necessary. Our study provides preliminary data to suggest that advanced supply of EC may help decrease repeat teen pregnancies.

Mifepristone: where do we come from and where are we going? Clinical development over a quarter of a century - Corrected Proof

Irving M. Spitz — 2010-02-01

Abstract: Administration of mifepristone followed by the prostaglandin, misoprostol, has been used successfully in the medical termination of pregnancy for over 25 years, and the method is registered in 35 countries. Single doses of mifepristone are also effective as an emergency postcoital contraceptive. Mifepristone administered for 3 months or longer to women with uterine leiomyomas, is associated with a reduction in pain and bleeding with improvement in quality of life and decrease in fibroid size. Mifepristone is also effective in decreasing pain in women with endometriosis. In both these conditions, serum estradiol levels are in the range of those in the early follicular phase. A daily dose of at least 2 mg mifepristone blocks ovulation. In contrast, weekly administration of 25 or 50 mg does not consistently block ovulation but has contraceptive potential by delaying endometrial development. Mifepristone in a dose of 200 mg, administered 48 h after the Luteinizing Hormone (LH) surge, also acts as a contraceptive, but this strategy is not practical for widespread use. Administration of mifepristone for 4–6 months or longer may lead to endometrial thickening. Endometrial histology reveals cystic glandular dilation together with admixed estrogen (mitotic) and progestin (secretory) epithelial effects. This histological pattern does not represent endometrial hyperplasia.

Randomized trial of buccal versus vaginal misoprostol for induction of second trimester abortion - Corrected Proof

Sacheen Carr Ellis, Nathalie Kapp, Olivera Vragpvoc, Lynn Borgata — 2010-02-01

Abstract: Background: We evaluated the efficacy and acceptability of repeat doses of buccal misoprostol compared to vaginal misoprostol for second trimester pregnancy termination by induction.Study Design: Women requesting termination of a pregnancy between18 and 22 weeks gestation were approached for participation. All women received 400 mcg misoprostol vaginally on admission. Participants were randomized to receive subsequent doses of 200 mcg misoprostol every 6 h either buccally or vaginally. All participants completed an acceptability survey.Results: Sixty-four women participated. The mean gestational age was 19.7 weeks. The median time to abortion in the buccal group was 15 h, which was not significantly different (p=0.44) from the vaginal-only group of 12 h. Most women in both groups preferred their allocated administrative route.Conclusion: Repeat doses of buccal misoprostol are as effective as vaginal misoprostol in inducing abortions in the midtrimester and are highly acceptable to most women. It is reasonable to offer both options to women.

Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials - Corrected Proof

Regina M. Renner, Jeffrey T. Jensen, Mark D. Nichols, Alison B. Edelman — 2010-01-28

Abstract: Background: First-trimester abortions especially cervical dilation and suction aspiration are associated with pain despite various methods of pain control.Study Design: Following the guidelines for a Cochrane review, we systematically searched for and reviewed randomized controlled trials comparing methods of pain control in first-trimester surgical abortion at less than 14 weeks gestational age using electric or manual suction aspiration. Outcomes included intra- and postoperative pain, side effects, recovery measures and satisfaction.Results: We included 40 trials with 5131 participants. Because of heterogeneity, we divided studies into seven groups:Local anesthesia: Data were insufficient to show a clear benefit of a paracervical block (PCB) compared to no PCB. Reported mean pain scores (10-point scale) during dilation and aspiration were improved with carbonated lidocaine [weighted mean difference (WMD), −0.80; 95% confidence interval (CI), −0.89 to −0.71; WMD, −0.96; 95% CI, −1.67 to −0.25], deep injection (WMD, −1.64; 95% CI, −3.21 to −0.08; WMD, 1.00; 95% CI, 1.09 to 0.91), and with adding a 4% intrauterine lidocaine infusion (WMD, −2.0; 95% CI, −3.29 to −0.71; WMD, −2.8; 95% CI, −3.95 to −1.65).PCB with premedication: Ibuprofen and naproxen resulted in small reduction of intra- and postoperative pain.Conscious sedation: The addition of conscious intravenous sedation using diazepam and fentanyl to PCB decreased procedural pain.General anesthesia: Conscious sedation increased intraoperative but decreased postoperative pain compared to general anesthesia (GA) [Peto odds ratio (Peto OR) 14.77 (95%, CI 4.91–44.38) and Peto OR 7.47 (95% CI, 2.2–25.36) for dilation and aspiration, respectively, and WMD −1.00 (95% CI, −1.77 to −0.23) postoperatively). Inhalation anesthetics are associated with increased blood loss (p<0.001).GA with premedication: The cyclooxygenase (COX)-2 inhibitor etoricoxib; the nonselective COX inhibitors lornoxicam, diclofenac and ketorolac IM; and the opioid nalbuphine improved postoperative pain.Nonpharmacological intervention: Listening to music decreased procedural pain.No major complication was observed.Conclusions: Conscious sedation, GA and some nonpharmacological interventions decreased procedural and postoperative pain, while being safe and satisfactory to patients. Data on the widely used PCB are inadequate to support its use, and it needs to be further studied to determine any benefit.

Factors associated with contraceptive nonuse among US women ages 35–44 years at risk of unwanted pregnancy - Corrected Proof

Kristen Upson, Susan D. Reed, Sarah W. Prager, Melissa A. Schiff — 2010-01-28

Abstract: Background: Women ages 35 years and older have the greatest proportion of contraceptive nonuse and unintended pregnancies ending in abortion.Study Design: We conducted a population-based case-control study among women ages 35–44 years at risk of unwanted pregnancy using the National Survey of Family Growth (NSFG) data to investigate risk factors for contraceptive nonuse.Results: At last intercourse, 9.8% of women reported not using any contraceptive method. Contraceptive nonusers, as compared to users, were more likely to be ages 40–44 years (OR=2.0, 95% CI 1.1–3.7), foreign-born (OR=4.3, 95% CI 1.9–9.7), black (OR=2.8, 95% CI 1.1–7.0), with household incomes 100–249% of the federal poverty level (FPL) (OR=2.5, 95% CI 1.1–5.8). Women who received contraceptive counseling in the past year had an 80% decreased risk of nonuse (95% CI 0.1–0.5).Conclusion: Public health strategies to reduce unintended pregnancy, particularly among women ages 35 years and older, should focus on addressing disparities in contraceptive use and promoting contraceptive counseling.

Use of oral contraceptives containing gestodene and risk of venous thromboembolism: outlook 10 years after the third-generation “pill scare” - Corrected Proof

Lothar A.J. Heinemann, Jürgen C. Dinger, Anita Assmann, Thai Do Minh — 2010-01-28

Abstract: Background: This study investigated whether gestodene-containing oral contraceptives (OCs) carry a higher risk of venous thromboembolism (VTE) than OCs containing progestins other than desogestrel and gestodene. The study was conducted based on the hypothesis that the biases and confounding factors that were present initially after the introduction of new so-called “third-generation” OCs (i.e., those containing desogestrel and gestodene) in the 1990s, which likely contributed to the alleged increased risk of VTE, may have vanished after 10 years.Study Design: This was a matched case-control study using data identified for women (aged 15–49 years) with suspected or diagnosed VTE (deep vein thrombosis or pulmonary embolism) that occurred between January 2002 and February 2006 in Austria. All VTE cases were validated by an attending/relevant physician(s), a detailed review of medical records and patient-completed questionnaires. Data were analyzed using an unconditional logistic regression model with adjustment for relevant confounders.Results: Overall, 451 VTE cases and 1,920 controls without VTE were identified. The adjusted odds ratios for confirmed VTE with OC use versus nonuse were: 3.39 (95% CI 2.36–4.87) for OCs containing gestodene and 3.14 (2.1–4.47) for OCs containing progestins other than desogestrel and gestodene. Adjusted odds ratios for a head-to-head comparison of OCs containing gestodene versus OCs containing progestins other than desogestrel and gestodene were: 0.99 (0.68–1.45) for all cases; 1.01 (0.69–1.47) for confirmed cases and 1.11 (0.73–1.69) for confirmed and idiopathic VTE cases, respectively.Conclusion: The risk of VTE is not elevated in users of gestodene-containing OCs relative to users of OCs containing progestins other than desogestrel and gestodene. Our study supports the view that (i) the majority of previous results may be explained by differences in the user populations of so-called “third-generation” OCs (containing desogestrel and gestodene) and “second-generation” OCs (containing progestins other than desogestrel and gestodene) that were present shortly after market introduction of gestodene-containing OCs and that (ii) these differences seem to have disappeared over time.

Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation - Corrected Proof

2010-01-28

Abstract: Background: We aimed to evaluate whether emergency contraception with levonorgestrel (LNG-EC) administered after ovulation is equally effective to LNG-EC administered before ovulation.Study design: We studied a cohort of women attending a family planning clinic for EC. From interview, we recorded menstrual history, time of intercourse and of intake of LNG-EC. On the day of intake of LNG-EC and during 5 days' follow-up, blood samples were taken for examination of luteinizing hormone, estradiol and progesterone concentrations, and vaginal ultrasound examinations were done for size of the leading follicle and/or corpus luteum. Thereafter women were not contacted until next menses or pregnancy occurred.Results: Of 388 women attending for LNG-EC, 122 women had intercourse on fertile cycle days according to ultrasound and endocrine findings. At the time of LNG-EC intake, 87 women were in Days −5 to −1 and 35 women were in Day 0 (day of ovulation) or beyond. With the use of the probability of clinical pregnancy reported by Wilcox et al. [N Engl J Med 333 (1995) 1517–1521], expected numbers of pregnancies among the 87 and 35 women were 13 and 7, respectively, while 0 and 6 pregnancies, respectively, occurred.Conclusion: We conclude that LNG-EC prevents pregnancy only when taken before fertilization of the ovum has occurred.

ORTHO EVRA® and venous thromboembolism: an update - Corrected Proof

Susan S. Jick, Katrina W. Hagberg, James A. Kaye — 2010-01-28

This is an update of previous studies published in Contraception on the safety of ORTHO EVRA® (EVRA) in relation to venous thromboembolism (VTE), where all new cases of VTE have been identified from an additional 14 months of claims data. The first two studies found that there was no increased risk of VTE in users of EVRA compared to users of norgestimate-containing oral contraceptive with 35 mcg of ethinyl estradiol (EE) (norgestimate-OC), the first study yielding an odds ratio (OR) of 0.9 (95% CI 0.5–1.6) and the second study an OR of 1.1 (95% CI 0.6–2.1). Data for these studies were derived from the IMS/PharMetrics database, a United States-based, ongoing longitudinal database with information on around 55 million covered lives going back as far as 1995. This update of the original studies, which were published in 2006 and 2007, included all data that were collected through October 2007. The methods for this study were the same as for the earlier studies and are summarized here. The base population was composed of 297,262 women, all 15–44 years old who were first-time users of EVRA or a norgestimate-OC between April 1, 2002, and October 31, 2007. Of these, around 121,500 women had received prescriptions for EVRA and around 188,200 had received prescriptions for a norgestimate-OC (note that some women received prescriptions for both). A first-time user means that this is the first recorded use of either study contraceptive in the subject's computer record, though they may have used another oral contraceptive prior to use of one of the study contraceptives. We excluded all women with any code for cancer (except for nonmelanoma skin cancer), renal failure or chronic inflammatory disease, which are all strong risk factors for VTE.

After 10 years: has approval of oral contraceptives really decreased the rate of unintended pregnancy in Japan? - Corrected Proof

Yasuyo Matsumoto, Shingo Yamabe — 2010-01-25

Ten years has passed since low-dose combined oral contraceptives (OC) were approved for marketing by the Ministry of Health and Welfare in Japan. OC was first requested to be licensed in Japan in 1965; however, the ministry did not permit approval because of the side effects and potential public moral hazard. However, middle-dose combined estrogen and progestin pills had been used as an off-label drug for contraceptive purposes before the approval of low-dose OC.

Extended case-control study results on thromboembolic outcomes among transdermal contraceptive users - Corrected Proof

David D. Dore, Heather Norman, Jeanne Loughlin, John D. Seeger — 2010-01-25

Abstract: Background: We extended an earlier study that found a twofold higher risk of venous thromboembolism (VTE) associated with the transdermal contraceptive system relative to norgestimate-containing oral contraceptives (NGM-OC).Study Design: This case-control study identified potential cases of VTE, acute myocardial infarction (AMI) and stroke from 24 months of additional health care claims, with adjudication via medical records. Randomly selected controls were matched to cases on age (15–44 years) and characteristics of contraception use. Conditional logistic regression models provided odds ratios (ORs) and 95% confidence intervals (CIs).Results: The transdermal contraceptive system was associated with a twofold higher risk of VTE (OR 2.0; 95% CI 1.2–3.3) compared with users of NGM-OC. The OR for stroke was 0.6 (95% CI 0.1–3.2) and for AMI 1.2 (95% CI 0.3–4.7).Conclusion: This extension was consistent with the earlier study, showing a twofold increased risk of VTE associated with use of the transdermal contraceptive system relative to NGM-OC.

Role of menstruation in contraceptive choice among HIV-infected women in Soweto, South Africa - Corrected Proof

2010-01-25

Abstract: Background: Contraceptive preferences of HIV-infected women must be considered in efforts to integrate HIV and reproductive health services. In South Africa, contraception is often discontinued due to bleeding pattern changes. It is unknown whether HIV-infected women are more sensitive to menstrual changes and how this affects contraceptive choice. This study describes perceptions toward menses and contraceptive-induced amenorrhea among HIV-infected women.Study Design: A convenience sample of 42 HIV-infected women aged 15 to 45 years was purposively recruited for three focus groups and 15 in-depth qualitative interviews which were conducted at the Perinatal HIV Research Unit, South Africa. Transcripts were coded and emergent themes grouped.Results: One third of women reported HIV-related menstrual changes, unchanged by antiretroviral use. Menstruation was believed to purge the body of “dirty blood.” Women perceived that menstruation had a negative effect on male partner sexual desire, with concern about higher HIV transmission during menstruation. Ninety-six percent of injectable contraceptive users experienced amenorrhea, regarded as troublesome and a reason for discontinuation.Conclusion: In Soweto, HIV diagnosis may accentuate linking menstruation with health, leading to avoidance or discontinuation of methods causing amenorrhea. Providers should intensify education on the safety of contraceptive-induced oligo/amenorrhea.

An open-label, comparative study of the effects of a dose-reduced oral contraceptive containing 0.02 mg ethinylestradiol/2 mg chlormadinone acetate on hemostatic parameters and lipid and carbohydrate metabolism variables - Corrected Proof

Ulrich H. Winkler, Petra Röhm, Kornelia Höschen — 2010-01-15

Abstract: Objective: The study was conducted to compare the effects of 0.02 mg ethinylestradiol (EE)/2 mg chlormadinone acetate (CMA), given for 24 days each cycle, with those of 0.02 mg EE/0.15 mg desogestrel (DSG) and 0.03 mg EE/0.15 mg levonorgestrel (LNG), given for 21 days each cycle, on hemostatic, lipid, and carbohydrate metabolism parameters in healthy subjects, over six medication cycles.Study design: A randomized, multicentre, open-label, Phase II trial measured markers of hemostasis, and of lipid and carbohydrate metabolism in 165 subjects randomly assigned to treatment with one of three combined oral contraceptives (COCs).Results: EE/CMA and EE/DSG had a similar effect on hemostatic parameters, the EE/LNG group showed comparatively smaller increases in the activity of factor VII [8.1% vs. 36.6% (EE/CMA) and 28.2% (EE/DSG)], protein C [5.9% vs. 32.9% (EE/CMA) and 21% (EE/DSG)] and endogenous thrombin potential-based activated protein C resistance [44.1% vs. 93.5% (EE/CMA) and 108.1% (EE/DSG)], and in contrast, free protein S levels decreased in the EE/CMA and EE/DSG groups (−12.7% and −4.3%, respectively) but rose in the EE/LNG group (20.4%). In all treatments, total cholesterol, total triglyceride and apolipoproteins increased. Levels of very low-density lipoprotein cholesterol particularly rose across all groups. Slight increases in high-density lipoprotein (HDL) cholesterol were observed for EE/CMA (14.6%) and EE/DSG (8.5%), with a rise above the upper limit of normal in 30% of the subjects taking EE/CMA. Conversely, for EE/LNG slight decreases in HDL cholesterol were observed (−12.4%) lipoprotein (a) levels decreased in the EE/CMA (−6.6%) and EE/LNG (−16.9%) groups and were unchanged in the EE/DSG group.Conclusions: The changes observed were typical of those seen across low-dose COCs that differ according to commonly-used progestogens.

Implanon as a contraceptive choice for teenage mothers: a comparison of contraceptive choices, acceptability and repeat pregnancy - Corrected Proof

Lucy N. Lewis, Dorota A. Doherty, Martha Hickey, S. Rachael Skinner — 2010-01-15

Abstract: Background: This study was conducted to compare the incidence of repeat teenage pregnancy over a 24-month period postpartum among users of Implanon, the combined oral contraceptive pill (COCP) or depot medroxyprogesterone acetate (DMPA) and barrier methods or nothing (barrier/none). Contraceptive continuation rates 24 months postpartum for Implanon and COCP/DMPA were also compared.Study Design: A prospective cohort study was conducted. Comparison groups were postpartum teenagers (12–18 years old) who self-selected Implanon (n=73), COCP/DMPA (n=40) and barrier/none (n=24). Questionnaires were used to gather data at recruitment and postpartum at 6 weeks and then 3 monthly intervals for 2 years.Results: At 24 months postpartum, 48 (35%) teenagers had conceived. Implanon users became pregnant later than other contraceptive groups (p=.022), with mean time to first repeat pregnancy of 23.8 months [95% confidence interval (CI), 22.2–25.5], compared to 18.1 months (95% CI, 15.1–20.7) for COCP/DMPA and 17.6 months (95% CI, 14.0–21.3) for barrier/none. Implanon users were more likely to continue their use at 24 months than COCP/DMPA (p<.001) users. The mean duration for Implanon users was 18.7 months (95% CI, 17.0–20.3) compared to 11.9 months (95% CI, 9.5–14.3) for COCP/DMPA.Conclusion: Teenagers who choose Implanon are significantly less likely to become pregnant and were found to continue with this method of contraception 24 months postpartum compared to those who choose COCP or DMPA and barrier methods or nothing.