Contraception - Articles in Press

Correlates of use of long-acting reversible methods of contraception among adolescent and young adult women - Corrected Proof

Amy K. Whitaker, Annie M. Dude, Amy Neustadt, Melissa L. Gilliam — 2010-02-01

Abstract: Background: Most pregnancies among adolescent and young adult women are unintended, and adolescent birth rates have risen. Use of long-acting reversible contraception may be an effective strategy to reduce the rate of unintended pregnancy.Study Design: We conducted a secondary data analysis of nationally representative, cross-sectional data from the 2002 National Survey of Family Growth. Our sample included 1722 sexually active women aged 15–24 years. We used multivariable logistic regression to identify correlates of ever-use of depot-medroxyprogesterone acetate (DMPA) or the intrauterine device (IUD).Results: One-quarter of our sample had ever used DMPA, and less than 2% had ever used the IUD. In multivariable analysis, increasing parity was associated with ever-use of DMPA (OR 2.07, 95% CI 1.55–2.77) and ever-use of the IUD (OR 4.57, 95% CI 1.60–13.03), but age and measures of socioeconomic status were not. Having ever been married (OR 5.54, 95% CI 1.23–24.82) and current cohabitation (OR 4.89, 95% CI 1.10–21.71) were associated with ever-use of the IUD. A history of an adolescent pregnancy was associated with ever-use of DMPA (OR 1.79, 95% CI 1.19–2.70) but not of the IUD.Conclusions: While similarities exist between the correlates of use of DMPA and the IUD, we discovered important differences, some of which may reflect provider biases regarding IUD provision.

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.

Pregnancy coercion, intimate partner violence and unintended pregnancy - Corrected Proof

2010-01-29

Abstract: Background: Reproductive control including pregnancy coercion (coercion by male partners to become pregnant) and birth control sabotage (partner interference with contraception) may be associated with partner violence and risk for unintended pregnancy among young adult females utilizing family planning clinic services.Study Design: A cross-sectional survey was administered to females ages 16–29 years seeking care in five family planning clinics in Northern California (N=1278).Results: Fifty-three percent of respondents reported physical or sexual partner violence, 19% reported experiencing pregnancy coercion and 15% reported birth control sabotage. One third of respondents reporting partner violence (35%) also reported reproductive control. Both pregnancy coercion and birth control sabotage were associated with unintended pregnancy (AOR 1.83, 95% CI 1.36–2.46, and AOR 1.58, 95% CI 1.14–2.20, respectively). In analyses stratified by partner violence exposure, associations of reproductive control with unintended pregnancy persisted only among women with a history of partner violence.Conclusions: Pregnancy coercion and birth control sabotage are common among young women utilizing family planning clinics, and in the context of partner violence, are associated with increased risk for unintended pregnancy.

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 desogestrel. 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.

Erratum to “Bleeding pattern with drospirenone 3 mg+ethinyl estradiol 20 mcg 24/4 combined oral contraceptive compared with desogestrel 150 mcg+ethinyl estradiol 20 mcg 21/7 combined oral contraceptive” [Contraception 2009;80:445–51] - Corrected Proof

Leena Anttila, Michael Kunz, Joachim Marr — 2010-01-28

In the abovementioned article, incorrect data were included for the drsp 3 mg/EE 20 mcg 24/4 group in A on page 448. The correct data are included in the figure shown here. The figure now supports the statement that scheduled bleeding intensity tended to be lighter for the drsp 3 mg/EE 20 mcg 24/4 group than for the DSG 150 mcg/EE 20 mcg 21/7 group.

Bringing research to life: a collaborative partnership dedicated to improving reproductive health care - Corrected Proof

Wayne C. Shields, Susan Higginbotham — 2010-01-28

The Society of Family Planning (SFP) and the Association of Reproductive Health Professionals (ARHP) are two organizations with different but complementary missions. Together, we write this editorial in order to raise awareness of how we work collaboratively, specifically around translating scientific research in family planning and abortion into direct patient care.

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.

Can Lactobacillus acidophilus influence the adhesion capacity of Candida albicans on the combined contraceptive vaginal ring? - Corrected Proof

2010-01-25

Abstract: Background: This study was conducted to evaluate the influence of Lactobacillus acidophilus on the adhesion capacity of Candida albicans on the combined contraceptive vaginal ring (CCVR).Study Design: Two vaginal isolates of C. albicans and an ATCC strain of lactobacilli were used. Isolated and associated yeasts and bacteria (co-aggregated) were employed on the CCVR adherence assays and scanning electron microscopy (SEM).Results: Isolated yeasts and lactobacilli adhered strongly to the CCVR. After the co-aggregation, there were an increase in adhesion capacity of the yeasts (p<.001) and a diminished adhesion of the lactobacilli (p<.001). SEM showed the isolated and co-aggregated microorganisms intimately attached to the irregularities of the CCVR.Conclusions: If these findings correlated with the conditions in vivo, the use of probiotics based on L. acidophilus or its presence in the vaginal microbiota would not protect against the adhesion of C. albicans to the ring.

Two medical abortion regimens for late first-trimester termination of pregnancy: a prospective randomized trial - Corrected Proof

2010-01-15

Abstract: Background: Medical abortion regimens based on the use of either misoprostol alone or in association with mifepristone have shown high efficacy and excellent safety profile in early pregnancy abortion. However, no clear recommendation is available for late first-trimester termination of pregnancy.Study Design: A prospective randomized controlled trial included 122 women seeking medical abortion at 9 to 12 weeks of gestation. Seventy-three patients were given a fixed protocol of 200 mg of mifepristone followed 48 h later by 400 mcg oral misoprostol (Group 1). The second group of 49 patients was administered 800-mcg intravaginal single-dose misoprostol (Group 2). This study sought to compare safety, efficacy and acceptability of these two nonsurgical abortion regimens.Results: Fifty-nine (80.8%) women in Group 1 had complete abortion vs. 38 (77.4%) women in Group 2 (p=.66). Abdominal pain was observed significantly more often in Group 2 (35/49 (71.4%) vs. 32/73 (43.8%) in Group 1, p<.0001. Medical abortion was equally acceptable among the two groups [37/49 (75.5%) and 55/73 (75.7%), p=.89].Conclusion: For late first-trimester termination, a single 800-mcg vaginal dose of misoprostol seems to be as effective as the mifepristone+misoprostol regimen, with acceptable side effects.

Does over-exposure to copper ions released from metallic copper induce cytotoxic and genotoxic effects on mammalian cells? - Corrected Proof

Claudia A. Grillo, Miguel A. Reigosa, Mónica A. Fernández Lorenzo de Mele — 2010-01-15

Abstract: Background: A high dissolution of copper from intrauterine devices (IUDs) occurs during the first days after insertion. This work is focused on the assessment of the possible cyto- and genotoxic effects of different concentrations of copper ions released from metallic copper on mammalian cells in vitro.Study design: Colorimetric tetrazolium/Trypan blue (TB) tests and Comet assay were used to evaluate potential cytotoxicity and genotoxicity, respectively, in Chinese hamster ovary cells (CHO-K1).Results: Reduction of mitochondrial activity by copper ions was observed for extracts at ≥7.42 mg/L concentrations, while TB exclusion test for plasma membrane integrity showed significant decrease in cell viability (close to 90%) for 10.85 mg/L concentration. Additionally, copper-induced DNA damage was detected for 5.67–7.42 mg/L concentration range.Conclusion: Our results demonstrate cytotoxic and genotoxic effects of copper ions released from metallic copper on CHO-K1 cells and emphasize the importance of reducing the initial copper dissolution from IUD without affecting the contraceptive action.

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.

Relationship of intraamniotic digoxin to fetal demise - Corrected Proof

Lynn Borgatta, Sarah J. Betstadt, Ann Reed, Kui-tzu Feng — 2010-01-11

Abstract: Background: Induced fetal demise by intraamniotic injection of digoxin is an alternative to methods using intracardiac or umbilical vein injection. This study was designed to evaluate the effectiveness of intraamniotic injection and the timing of fetal demise after injection.Study Design: Twenty-two women had ultrasonic fetal cardiac assessments 1, 2, 4 and 20 to 24 h after intraamniotic injection of 1.5 mg digoxin.Results: Fetal cardiac activity was absent in 21/21 women assessed at least 20 h after injection. One woman had agonal (40 bpm) fetal cardiac activity at 14 h. Most women had fetal cardiac activity 4 h after injection. Signs of toxicity were not seen.Conclusion: Intraamniotic injection of digoxin 1.5 mg is effective at causing fetal demise by 20 to 24 h. However, for most women, fetal demise is not obtained within 4 h.

Clinical pharmacokinetics and interaction of centchroman — A mini review - Corrected Proof

Jawahar Lal — 2010-01-04

Abstract: This article provides a brief review of the information available regarding the published pharmacokinetics data for the nonsteroidal, once-a-week oral contraceptive, centchroman (INN: ormeloxifene). This agent is a unique need-oriented contraceptive agent which is included in the National Family Welfare Programme of India. Since 1991, centchroman has been used as a need-oriented contraceptive and is being given for treating dysfunctional bleeding of the uterus. Information regarding absorption, tissue distribution, elimination and kinetic interactions is discussed.

Multipurpose prevention technologies for sexual and reproductive health: gaining momentum and promise - Corrected Proof

2010-01-04

Over the past four decades, the world has made substantial gains in the effort to prevent unplanned pregnancies and reduce the risk of sexually transmitted infections (STIs), including HIV, and other reproductive tract infections (RTIs). Yet, STIs and RTIs still cause a heavy health burden, especially in developing countries, and there is an equally urgent unmet need for contraception .

Intrauterine administration of CDB-2914 (Ulipristal) suppresses the endometrium of rhesus macaques - Corrected Proof

Robert M. Brenner, Ov D. Slayden, Anita Nath, Y.Y. Tsong, Regine Sitruk-Ware — 2009-12-17

Abstract: Background: Ulipristal (UPA; CDB-2914) is a progesterone receptor modulator with contraceptive potential. To test its effects when delivered by an intrauterine system (IUS), we prepared control and UPA-filled IUS and evaluated their effects in rhesus macaques.Study Design: Short lengths of Silastic tubing either empty (n=3) or containing UPA (n=5) were inserted into the uteri of 8 ovariectomized macaques. Animals were cycled by sequential treatment with estradiol and progesterone. After 3.5 cycles, the uterus was removed.Results: During treatment, animals with an empty IUS menstruated for a mean total of 11.66±0.88 days, while UPA-IUS treated animals bled for only 1±0.45 days. Indices of endometrial proliferation were significantly reduced by UPA-IUS treatment. The UPA exposed endometria were atrophied with some glandular cysts while the blank controls displayed a proliferative morphology without cysts. Androgen receptors were more intensely stained in the glands of the UPA-IUS treated endometria than in the blank-IUS treated controls.Conclusions: In rhesus macaques, a UPA-IUS induced endometrial atrophy and amenorrhea. The work provides proof of principle that an IUS can deliver effective intrauterine concentrations of Ulipristal.

Recovery of bone mineral density in adolescents following the use of depot medroxyprogesterone acetate contraceptive injections - Corrected Proof

2009-12-14

Abstract: Background: Depot medroxyprogesterone acetate (DMPA) is a highly effective progestin-only contraceptive that is widely used by adolescents. We investigated bone mineral density (BMD) changes in female adolescents during and following use of this method.Study Design: A multicenter, prospective, non-randomized observational study in 98 healthy female adolescents aged 12–18 years who initiated DMPA intramuscular injections for contraception and provided BMD data for up to 240 weeks while receiving DMPA and for up to 300 weeks after DMPA cessation. BMD at the lumbar spine (LS), total hip (TH) and femoral neck (FN) was assessed by dual-energy X-ray absorptiometry. A mixed model analysis of variance was used to examine BMD changes.Results: At the time of their final DMPA injection, participants had mean BMD declines from baseline of 2.7% (LS), 4.1% (TH) and 3.9% (FN) (p<.001 at all three sites). Within 60 weeks of discontinuation of DMPA, mean LS BMD had returned to baseline levels, and 240 weeks after DMPA discontinuation, the mean LS BMD was 4.7% above baseline. Mean TH and FN BMD values recovered to baseline values more slowly: 240 weeks and 180 weeks, respectively, after the last DMPA injection.Conclusions: BMD loss in female adolescents receiving DMPA for contraception is substantially or fully reversible in most girls following discontinuation of DMPA, with faster recovery at the LS than at the hip.

Health care providers' knowledge about contraceptive evidence: a barrier to quality family planning care? - Corrected Proof

Christine Dehlendorf, Kira Levy, Rachel Ruskin, Jody Steinauer — 2009-12-11

Abstract: Background: The underuse of effective contraceptive methods by women at risk for unintended pregnancy is a major factor contributing to the high rate of unintended pregnancy in the United States. As health care providers are important contributors to women's contraceptive use, this study was conducted to assess provider knowledge about contraception.Study Design: Bivariate and multivariate analyses were performed using data collected from a convenience sample of health care providers (physicians, nurse practitioners and physician assistants) at meetings of the professional societies of family medicine and obstetrics and gynecology.Results: Younger providers were more knowledgeable, as were obstetrician/gynecologists, female providers and providers who provide intrauterine contraception in their practice.Conclusions: The lack of consistent and accurate knowledge about contraception among providers has the potential to dramatically affect providers' ability to provide quality contraceptive care for their patients, which could have an impact on their ability to prevent unintended pregnancies.

Sino-implant (II) — a levonorgestrel-releasing two-rod implant: systematic review of the randomized controlled trials - Corrected Proof

2009-12-07

Abstract: Background: Sino-implant (II) is a subdermal contraceptive implant manufactured in China. This two-rod levonorgestrel-releasing implant has the same amount of active ingredient (150 mg levonorgestrel) and mechanism of action as the widely available contraceptive implant Jadelle. We examined randomized controlled trials of Sino-implant (II) for effectiveness and side effects.Study Design: We searched electronic databases for studies of Sino-implant (II) and then restricted our review to randomized controlled trials. The primary outcome of this review was pregnancy.Results: Four randomized trials with a total of 15,943 women assigned to Sino-implant (II) had first-year probabilities of pregnancy ranging from 0.0% to 0.1%. Cumulative probabilities of pregnancy during the 4 years of the product's approved duration of use were 0.9% and 1.06% in the two trials that presented date for 4-year use. Five-year cumulative probabilities of pregnancy ranged from 0.7% to 2.1%. In one trial, the cumulative probability of pregnancy more than doubled during the fifth year (from 0.9% to 2.1%), which may be why the implant is approved for 4 years of use in China. Five-year cumulative probabilities of discontinuation due to menstrual problems ranged from 12.5% to 15.5% for Sino-implant (II).Conclusions: Sino-implant (II) is one of the most effective contraceptives available today. These available clinical data, combined with independent laboratory testing, and the knowledge that 7 million women have used this method since 1994, support the safety and effectiveness of Sino-implant (II). The lower cost of Sino-implant (II) compared with other subdermal implants could improve access to implants in resource-constrained settings.

Perceived competence and contraceptive use during adolescence - Corrected Proof

Jennifer B. Hillman, Sonya Negriff, Lorah D. Dorn — 2009-12-07

Abstract: Background: Little is known about psychosocial correlates of different contraceptive methods in adolescence.Study Design: Cross-sectional analyses of 209 postmenarcheal girls [mean age (years)±SD=15.68±1.74], primarily Caucasian (62.8%) or African American (32.8%). Competence (activities and social) and rule-breaking behavior were assessed by the Youth Self Report (YSR; adolescent) and the Child Behavior Checklist (CBCL; parent). Three contraceptive-use groups were created: no hormonal contraceptive (n=142), combined oral contraceptives or the transdermal patch (COCs/patch, n=41), and depot medroxyprogesterone acetate (DMPA, n=20).Results: There was a significant effect of contraceptive-use group on competence (p=.003). The DMPA group had lower competence (CBCL activities and social; YSR social) than the no-hormonal-contraceptive and COCs/patch groups. The COCs/patch group scored lower than the no-hormonal-contraceptive group on YSR activities competence, but was not different from the DMPA group. Lastly, there was an effect of contraceptive-use group on CBCL (but not YSR) rule-breaking behavior (p=.029) with the DMPA group having higher rule-breaking behavior than the other groups.Conclusions: Type of contraceptive method was associated with parent and adolescent's perceived competence. For rule-breaking behavior, parental perception may be more relevant to contraceptive use.

Cost–benefit analysis of state- and hospital-funded postpartum intrauterine contraception at a university hospital for recent immigrants to the United States - Corrected Proof

2009-12-07

Abstract: Objective: To examine the hospital and state costs of offering the option of a postpartum intrauterine device (IUD) to an underinsured population of recent immigrants to the United States with Emergency Medicaid (EM) insurance coverage only.Study Design: This study is a retrospective cohort study comparing the costs of offering a reversible long-acting method of contraception (IUD) postpartum to women with EM and the current policy of covering the obstetrical delivery only. A cost–benefit analysis from the perspective of both the hospital and the state was conducted. A database of EM obstetrical patients from 2002 to 2006 was created from hospital billing records to calculate mean pregnancy costs and revenue, as well as the probability of repeat pregnancy and pregnancy outcome. Probability of IUD uptake and continuation was obtained from hospital records and the literature.Results: A postpartum IUD program is not cost beneficial from the hospital's perspective, losing 70 cents per dollar spent on the program. However, the state government would save $2.94 for every dollar spent on a state-financed IUD program.Conclusion: Considering only the direct costs associated with a repeat pregnancy, a program offering the option of postpartum IUD placement to underinsured women would significantly reduce state expenditures on subsequent pregnancies.

Effect of low-dose combined oral contraceptive on aerobic capacity and anaerobic threshold level in active and sedentary young women - Corrected Proof

2009-12-07

Abstract: Background: The purpose of this study was to evaluate the effect of long-term use of oral contraceptives (OC) containing 0.20 mg of ethinylestradiol (EE) combined with 0.15 mg of gestodene (GEST) on the peak aerobic capacity and at the anaerobic threshold (AT) level in active and sedentary young women.Study Design: Eighty-eight women (23±2.1 years old) were divided into four groups — active-OC (G1), active-NOC (G2), sedentary-OC (G3) and sedentary-NOC (G4) — and were submitted to a continuous ergospirometric incremental test on a cycloergometer with 20 to 25 W min−1 increments. Data were analyzed by two-way ANOVA with Tukey post hoc test. Level of significance was set at 5%.Results: The OC use effect for the variables relative and absolute oxygen uptake V̇O2 mL kg−1 min−1; V̇O2, L min−1, respectively), carbon dioxide output (V̇CO2, L min−1), ventilation (VE, L min−1), heart rate (HR, bpm), respiratory exchange ratio (RER) and power output (W) data, as well as the interaction between OC use and exercise effect on the peak of test and at the AT level did not differ significantly between the active groups (G1 and G2) and the sedentary groups (G3 and G4). As to the exercise effect, for all variables studied, it was noted that the active groups presented higher values for the variables V̇O2, V̇CO2, VE and power output (p .05) at the peak and at the AT level between G1 vs. G3 and G2 vs. G4.Conclusions: Long-term use of OC containing EE 0.20 mg plus GEST 0.15 mg does not affect aerobic capacity at the peak and at the AT level of exercise tests.

Community-based health workers can safely and effectively administer injectable contraceptives: conclusions from a technical consultation - Corrected Proof

2009-12-03

In June 2009, a technical consultation held at the World Health Organization (WHO) in Geneva concluded that evidence supports the introduction, continuation and scale-up of community-based provision of progestin-only injectable contraceptives. The group of 30 technical and program experts reviewed scientific and programmatic experience, which largely focused on the progestin-only injectable depot-medroxyprogesterone acetate (DMPA). The experts found that community-based provision of progestin-only injectable contraceptives by appropriately trained community health workers (CHWs) is safe, effective and acceptable. Such services should be part of a family planning program offering a range of contraceptive methods.

Bleeding patterns and menstrual-related symptoms with the continuous use of a contraceptive combination of ethinylestradiol and drospirenone: a randomized study - Corrected Proof

Rogério Bonassi Machado, Nilson Roberto de Melo, Hugo Maia — 2009-11-23

Abstract: Background: The objective of this study was to compare bleeding patterns of women using a contraceptive combination of 30 mcg ethinylestradiol (EE) and 3 mg drospirenone (DRSP) continuously or cyclically. Menstrual-related symptoms were also evaluated.Study Design: This open, prospective, randomized study evaluated 78 women using the EE/DRSP combination continuously for 168 days or for six 28-day cycles, each followed by a 7-day hormone-free interval. A diary with pre-established scales was used to assess the frequency and intensity of bleeding and menstrual-related symptoms.Results: Amenorrhea increased with continuous use; 62.2% of women with continuous use were amenorrheic at the end of treatment (95% CI: 46.6–77.8%). Dysmenorrhea, headache, acne, nausea, edema and increased appetite improved significantly in the continuous-use group, and mastalgia and edema in the cyclic-use group (p<.05). Six subjects in the continuous-use group (15.4%) and three in the cyclic-use group (7.7%) discontinued due to adverse events.Conclusions: Continuous use was associated with amenorrhea and fewer menstrual-related symptoms compared to cyclic use.

Results of a safety and feasibility study of the diaphragm used with ACIDFORM Gel or K-Y® Jelly - Corrected Proof

2009-11-23

Abstract: Background: New strategies are needed for preventing HIV infection in women. One potential approach is female-initiated use of an effective topical microbicidal gel in combination with a cervical barrier such as the diaphragm.Study design: Randomized, placebo-controlled safety and feasibility trial of diaphragm with vaginal gel during 6 months of use among 120 HIV-negative sexually active women in Johannesburg, South Africa.Results: Pelvic event rates were 338.3 and 247.1 per 100 women-years in the ACIDFORM gel (plus diaphragm) and K-Y® Jelly (plus diaphragm) groups, respectively, with a rate ratio of 1.37 (95% CI: 0.89–2.11). Most women found diaphragm with gel use acceptable.Conclusion: There was a trend towards more safety events in the ACIDFORM plus diaphragm group, although no primary comparisons achieved statistical significance. Adding an effective microbicidal gel to a mechanical barrier may still prove to be an important and acceptable combination method to help prevent pregnancy and HIV/sexually transmitted infection transmission.

Antimullerian hormone and obesity: insights in oral contraceptive users - Corrected Proof

Anne Z. Steiner, Frank Z. Stanczyk, Stan Patel, Alison Edelman — 2009-11-16

Abstract: Background: The study was conducted to examine the impact of oral contraceptives (OCs) on serum antimullerian hormone (AMH) levels by obesity status in reproductive-age women.Study design: Ovulatory women, ages 18–35 years, of normal (<25 kg/m2; n=10) and obese (>30 kg/m2; n=10) body mass index (BMI) received a low-dose OC (20 mcg ethinyl estradiol/100 mcg levonorgestrel) for two cycles. Serum samples obtained at several time points during active pill use and hormone-free intervals were analyzed for AMH, follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol and inhibin B.Results: AMH levels did not differ by OC cycle day in either BMI group. On average, AMH levels were 34% lower in the obese group (2.9±2.1 vs. 4.4±1.8 ng/mL, p<.05). Modeling to determine differences in AMH throughout the cycle based on obesity status demonstrated significantly lower levels (p<.05), whereas serum AMH, FSH, LH, estradiol and inhibin B levels revealed no correlations when all time points were included.Conclusions: In reproductive-age women, serum AMH levels do not appear to fluctuate during OC use, but AMH levels are significantly lower in obese women. Lower levels do not appear to be due to differences in gonadotropin levels or ovarian activity.

Is there evidence for tripling the dose of 200 mg mifepristone for medical abortion? - Corrected Proof

2009-11-16

We would like to support and further add to the arguments made by Shannon and Winikoff in their recent letter commenting on the meta-analysis by Lièvre and Sitruk-Ware from which the authors concluded that ‘the substitution of 200 mg [of mifepristone] for 600 mg may lead to an increased continuing pregnancy rate’. We believe that this conclusion is erroneous and that the results of the meta-analysis concerning pregnancy rates are inconclusive. The 95% confidence interval (CI) for the difference in continuing pregnancy rates between the two mifepristone doses was −0.3% to 1.0%, indicating that negative values (200 mg better than 600 mg) as well as positive values (600 mg better than 200 mg) are likely.

Extended regimens of the contraceptive vaginal ring: evaluation of clinical aspects - Corrected Proof

2009-11-16

Abstract: Background: Oral contraceptives used for extended periods of time have been extensively studied because of their potential benefits; however, there have been few publications on extended regimens of vaginal contraceptive rings. The aim of this study was to evaluate the clinical symptoms, body weight and blood pressure changes in women using the vaginal ring continuously over a 1-year period.Study Design: This prospective cohort evaluated clinical aspects (dysmenorrhea, headache, breast tenderness, leg pain and irritability), body weight and blood pressure changes in 75 women (18–37 years of age) using a vaginal ring releasing 120 mcg of etonogestrel and 15 mcg of ethinyl estradiol daily, over a continuous period of 84 days, followed by a 7-day ring-free interval, during 1 year. The chi-square, Wilcoxon and paired t tests were used to analyze differences in the outcomes of interest.Results: Compared to pre-enrollment status, at the end of the study period, the patients reported significantly less dysmenorrhea and irritability, a nonsignificant decrease in breast tenderness, leg pain and headaches. Blood pressure measurements remained unchanged. Although weight and body mass index increased significantly among users, they remained within the expected biological variation range.Conclusion: The vaginal ring used on an extended regimen is a well-tolerated contraceptive method and also offers noncontraceptive benefits.

A comparison of transabdominal and transvaginal ultrasonography for determination of gestational age and clinical outcomes in women undergoing early medical abortion, - Corrected Proof

Patricia A. Lohr, Matthew F. Reeves, Mitchell D. Creinin — 2009-11-16

Abstract: Background: We sought to establish the accuracy of abdominal ultrasonography in determining gestational age and identifying the presence of a gestational sac and embryonic pole before and after medical abortion.Methods: We included all 120 women enrolled in a study of simultaneous oral mifepristone and buccal misoprostol for abortion through 63 days' gestation. Vaginal and abdominal ultrasound examinations were performed before and 24 h after medication administration. Visualization of a gestational sac and embryonic pole and presence or absence of cardiac activity were recorded. Sensitivity and specificity were calculated with the results from vaginal ultrasonography as the gold standard. The effect of body mass index (BMI) on ultrasound findings was also assessed.Results: Before treatment, the sensitivities of abdominal ultrasonography were 100% (95% CI 97–100) and 68% (95% CI 58–77) for presence of a gestational sac and an embryonic pole, respectively. Overall, abdominal imaging underestimated mean gestational age by 1.6 days (95% CI 1.0–2.2). After treatment, abdominal ultrasonography missed three of 34 retained gestational sacs (sensitivity 91%, 95% CI 76–98%). Fourteen women had gestational cardiac activity by vaginal ultrasound at follow-up. Abdominal imaging identified the gestational sac in all cases, but cardiac motion was only visible in 10 (71%, 95% CI 42–92%). For every 10-point increase in BMI, the odds ratio for missing an embryonic pole at baseline was 2.8 (95% CI 1.5–5.0).Conclusions: Abdominal ultrasonography is sensitive for diagnosing the presence or absence of a gestational sac, but less sensitive at detecting an embryonic pole. This may lead to a small underestimation of gestational age and missing a continuing pregnancy at follow-up when one exists.

Nonsteroidal anti-inflammatory drugs and hormonal contraceptives for pain relief from dysmenorrhea: a review - Corrected Proof

Hans-Peter Zahradnik, Aida Hanjalic-Beck, Klaus Groth — 2009-11-09

Abstract: Background: This article is a comprehensive overview of dysmenorrhea and a systematic review of the available literature on the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and hormonal contraceptives for the therapy and management of dysmenorrhea.Study Design: A comprehensive search of the PubMed database for clinical trials and observational studies of dysmenorrhea treatments from 2004 onwards.Results: Eighteen publications were identified. Ten randomized controlled trials (RCTs) assessing NSAIDs for treating primary dysmenorrhea demonstrated superior pain relief compared with placebo, but no superiority was established among different NSAIDS. Two RCTs and six nonrandomized observational or prospective studies assessing the effect of hormonal contraceptives on dysmenorrhea strongly suggest a beneficial effect for dysmenorrheic pain relief and were conducted mainly in larger populations (N=41–6169) than those in the NSAID trials (N=10–337). Ethinylestradiol/chlormadinone acetate was the only formulation that provided a more pronounced relief of dysmenorrheic pain compared with a parallel alternative or previously used hormonal contraceptive. Methodological inconsistencies were widespread between the hormonal contraceptive studies.Conclusions: The findings of this review support the use of NSAIDs as a first-line therapy for pain relief from dysmenorrhea in women without wish for contraception. For women who wish contraception, combined oral contraceptives (COCs) are the preferential therapy for pain relief from dysmenorrhea as the additional noncontraceptive benefit of pain relief from dysmenorrhea is not linked to additional risks, eliminates the risks associated with taking NSAIDs and is a more suitable long-term option. Recommendations are made to strengthen the impact of future trials through improved methodology.

Flexible mifepristone and misoprostol administration interval for first-trimester medical termination - Corrected Proof

Lilantha Wedisinghe, Deya Elsandabesee — 2009-10-30

Abstract: Background: The administration interval between mifepristone and misoprostol is usually about 36–48 h, which might affect a woman's choice of method of termination. Unwanted outcomes such as uterine bleeding, painful cramps and psychosocial issues which may occur during this long interval can be altered by a shorter administration interval. A shorter interval will be cost-effective as it saves both women's and clinician's time and other resources. If the waiting time interval between therapeutic interventions could be reduced without compromising efficacy, it will potentially improve compliance, patient acceptability and quality of care.Study design: A systematic review of randomized controlled trials published from 1999 to 2008 was conducted to assess the evidence for a shorter mifepristone and misoprostol administration interval at first trimester medical termination. Searching strategy included MEDLINE, EMBASE, CLINAHL and Cochrane Library. The primary outcome measure was complete abortion without the need for a surgical procedure.Results: Five randomized controlled trials (RCT) compared the efficacy of mifepristone and misoprostol administration intervals between 0 and 72 h in 5139 participants. The complete abortion rates varied between 90% and 98%. Although the meta-analysis of pooled data of all RCTs shows no statistically significant difference in efficacy between the shorter and longer dosing intervals, there is a trend toward slightly lower success rates with administration intervals earlier than 8 h.Conclusions: Overall efficacy of complete abortion is not statistically different between the longer and shorter administration intervals. This might encourage the clinician to adopt a ‘flexible policy’ with fully informed consent and consideration of all circumstances.

In vitro Actinomyces israelii biofilm development on IUD copper surfaces - Corrected Proof

2009-10-30

Abstract: Background: Female pelvic actinomycosis may involve fallopian tubes, ovaries, uterus and bladder. This condition is often associated with the use of intrauterine contraceptive devices (IUDs), vaginal pessaries and/or tampons. The predominant causative agent of human actinomycosis is Actinomyces israelii, which has been found on copper IUDs retrieved from patients.Study design: In this work, a biofilm of A. israelii was developed in vitro on copper surfaces immersed in a simulated uterine fluid under anaerobic conditions. The biofilm was characterized using scanning electron microscopy (SEM), energy dispersive X-ray and atomic force microscopy.Results: The capacity of A. israelii to develop a biofilm over copper surfaces in synthetic media was demonstrated. SEM micrographies illustrate the exopolysaccharides production and bacterial distribution.Conclusion: A. israelii was able to attach and grow in synthetic intrauterine media and to present on the copper surface is likely due to the production of biofilm.

Perceptions of the safety of oral contraceptives among a predominantly Latina population in Texas - Corrected Proof

2009-10-30

Abstract: Background: Fear of side effects and previous negative experiences are common reasons for contraceptive nonuse.Study Design: We collected information about perceptions of oral contraceptive (OC) safety from 1271 women 18-49 years old in El Paso, TX, and compared their responses to a medical evaluation by a nurse practitioner. We also asked participants about their interest in obtaining OCs over the counter (OTC).Results: Among 794 women potentially at risk of unintended pregnancy, 56.0% said that OCs were medically safe for them. Reasons given for OCs being unsafe were related to fears of side effects and prior negative experiences rather than true contraindications. Older women and participants recruited at the less affluent recruitment site were significantly more likely to report that OCs were medically unsafe for them (p<.05). Nonusers who thought OCs were medically unsafe for them were as likely to be medically eligible for use as current hormonal users. Among nonusers or nonhormonal users and potential OC candidates (n=601), 60.2% said they would be more likely to use OCs if they were available OTC.Conclusions: Women's perception of OC safety does not correlate well with medical eligibility for use. More education about the safety and health benefits of hormonal contraception is needed. OTC availability might contribute to more positive safety perceptions of OCs compared to a prescription environment.

Effects of the contraceptive patch and the vaginal ring on bone metabolism and bone mineral density: a prospective, controlled, randomized study - Corrected Proof

2009-10-30

Abstract: Background: This study was conducted to compare the effects of the combined contraceptive vaginal ring releasing 15 mcg of ethinylestradiol (EE) and 120 mcg of etonorgestrel daily with the effects of the contraceptive patch, a transdermal system that delivers a daily dose of 20 mcg of EE and 150 mcg of norelgestromin on bone turnover and bone mineral density (BMD) in young fertile women.Study Design: On the basis of a randomized, computer-generated list, 40 women desiring contraception were assigned to a 12-month treatment with a patch delivering a daily dose of 20 mcg of EE and 150 mcg of norelgestromin (Evra®, Janssen-Cilag, Italy) (Group A, n=20) or to a 12-month treatment with a vaginal ring releasing a daily dose of 15 mcg of EE and 120 mcg of etonorgestrel (NuvaRing®, Organon, Italy) (Group B, n=20). Twenty patients underwent no treatment and were used as healthy controls (Group C, n=20). At 3, 6, 9 and 12 months, serum and urinary calcium, osteocalcin and urinary pyridinoline (PYD) and deoxypyridinoline (D-PYD) levels were measured. At baseline and after 12 months, lumbar BMD was determined by dual-energy X-ray absorptiometry.Results: In Groups A and B, urinary PYD and D-PYD at 6, 9 and 12 months were significantly reduced in comparison with basal values and Group C values (p<.05). In Groups A and B, serum calcium levels were significantly increased after 6 months. No significant difference was detected between Group A and Group B in urinary levels of PYD and D-PYD, in calcium levels and in osteocalcin levels. At 12 months, no significant difference was detected in spinal BMD values between the three groups and in comparison with basal values.Conclusion: Both contraceptive systems exert a similar positive influence on bone turnover in young postadolescent women.

A randomized prospective trial comparing the levonorgestrel-releasing intrauterine system with thermal balloon ablation for the treatment of heavy menstrual bleeding - Corrected Proof

2009-10-30

Abstract: Background: Use of the levonorgestrel-releasing intrauterine system (LNG-IUS) was compared with thermal balloon ablation (TBA) for the treatment of heavy menstrual bleeding (HMB).Study Design: A prospective randomized trial comparing the LNG-IUS (n=30 women) and TBA (n=28 women).Results: Hemoglobin levels increased (p<.001) and blood loss was reduced (p<.001) in both groups after 1 year of treatment. Menstrual bleeding was less in the LNG-IUS group compared to the TBA group at 6 and 12 months of treatment (p=.035 and p=.048, respectively). Intermenstrual bleeding was significantly less in the TBA group at 6 months compared to the LNG-IUS group (p=.044); however, there was no significant difference at 12 months (p=.129). No difference was found in psychological aspects between pre- and posttreatment variables in either of the groups (p=.537).Conclusions: Both the LNG-IUS and TBA appear to be effective in controlling HMB; however, posttreatment uterine bleeding patterns are different.

Epidemiological and clinical aspects of migraine in users of combined oral contraceptives - Corrected Proof

2009-10-21

Abstract: Background: Migraine was assessed in users of combined oral contraceptives (COCs).Study Design: This study had a cross-sectional design. Women with headaches were evaluated according to International Headache Society criteria and subsequently allocated to a “migraine” or “non-migraine” group.Results: Migraine was detected in 80/480 women (16.6%), while other types of headache not classified as migraine were observed in 400 women (83.4%). Following COC use, headaches worsened in 32.5% and 19.3% [odds ratio (OR)=3.02; 95% confidence interval (CI)=1.68–5.4] and improved in 30% and 13.8% (OR=3.9; 95% CI=2.12–7.18) of the “migraine” and “non-migraine” groups, respectively. In the migraine group only, headache episodes occurred predominantly during or around the hormone-free interval (OR=2.05; 95% CI=1.26–3.35). The combination of ethinylestradiol (EE) and drospirenone (DRS) was significantly associated with an improvement in the frequency and/or intensity of migraine-type headaches, compared with other types of COCs.Conclusions: The prevalence of migraine in COC users appears similar to that found in the general population. Migraines, but not other types of headache, were significantly affected by COCs. The EE/DRS combination was associated with a greater likelihood of improvement in migraine compared with other types of COCs.

Comparative study on the spermicidal activity of organic solvent fractions from hydroethanolic extracts of Achyranthes aspera and Stephania hernandifolia in human and rat sperm - Corrected Proof

2009-10-05

Abstract: Background: This study was conducted to determine the most effective fraction of the hydroethanolic (water:ethanol, 1:1) extracts of Stephania hernandifolia leaves and Achyranthes aspera roots (in a composite manner at a ratio of 1:3, respectively) that will provide maximum spermicidal activity in human and rat spermatozoa out of five different ratios (1:1, 1:3, 1:7, 3:1 and 7:1) that have been studied in pilot experiments.Study design: n-Hexane, chloroform and ethyl acetate fractions of the hydroethanolic (1:1) extracts of S. hernandifolia and A. aspera were mixed at 1:3. Different concentrations were tested for sperm immobilization, sperm viability, acrosome status, 5′-nucleotidase activity and nuclear chromatin decondensation using human and rat spermatozoa for the selection of the most effective concentration.Results: Out of three fractions of the hydroethanolic (1:1) extracts of the said plants, the n-hexane fraction was most effective, and the chloroform fraction exhibited minimum activity for this purpose. At a concentration of 0.1 g/mL hexane fraction, all sperm of the human sample were immobilized immediately (within 20 s). In case of the rat sample, all epididymal spermatozoa were immobilized immediately (within 20 s) by treatment with hexane fraction at a concentration of 0.004 g/mL. All human sperm were found to be nonviable within 20 min. The activity of acrosome enzymes was reduced, and significant release of 5′-nucleotidase (a plasma membrane marker) into the surrounding medium was noted after treatment with 0.1 g/mL hexane fraction, indicating that the hexane fraction affected the cytoarchitecture of the sperm plasma membrane. The maximum number of human sperm failed to decondense when treated with 0.1 g/mL hexane fraction, and sperm motility was also irreversible. The hexane fraction was tested in rats as vaginal contraceptive and showed 100% efficacy, indicating its potential for development as vaginal contraceptive.Conclusion: The findings indicate that, among the different fractions, the hexane fraction of the hydroethanolic extracts of the two plants produced the most effective spermicidal activity and can be considered as vaginal contraceptive.