Acceptability of the Woman's Condom in a phase III multicenter open-label study.

OBJECTIVE: This study aimed to evaluate the acceptability of the Woman's Condom (WC) over 6 months (183 days) and ≥6 menstrual cycles in a US-based multicenter open-label phase III contraceptive efficacy trial. STUDY DESIGN: We assessed acceptability via written questionnaire at visit 2 (after the third cycle) and visit 3 (after the sixth cycle or >183 days, or upon early discontinuation). Key domains included ease of use, comfort/lubrication, sexual satisfaction, male partner satisfaction and confidence in pregnancy and sexually transmitted infection (STI) prevention. We analyzed quantitative data using descriptive statistics. We conducted a content analysis to identify major themes from four open-ended questions. RESULTS: Most women [327/405 (81%)] had limited or no previous experience with female (internal) condoms. Of 405 evaluable women, 346 women completed questionnaires at visit 2 and 303 women at visit 3; 282 women attended both visits. Of women attending both visits, 165/282 (59%) reported at visit 2 that WC insertion was easy/very easy; this increased to 195/282 (69%) at visit 3 (p=.03). Many women [166/281 (59%)] preferred the WC [105/281 (37%)] or were neutral [61/281 (22%)], while 115/281 (41%) preferred male condoms. Women attending visit 3 felt confident that the WC could prevent pregnancy [246/303 (81%)] and STIs [217/303 (72%)]. Many women expressed empowerment with having control over their contraception; some disliked the design, esthetics and insertion process. Most women (254/299 (85%)] would recommend the WC to a friend. CONCLUSION: The WC's acceptability and ease of use is promising for wider dissemination as a female-controlled method that can protect against both pregnancy and STIs. IMPLICATIONS: The WC's overall acceptability and ease of use is promising for a new female-controlled barrier contraceptive option that can protect against both pregnancy and sexually transmitted infections.

Depo-Provera (depot medroxyprogesterone acetate) use after bariatric surgery.

In the US, obesity rates are increasing greatly. The Centers for Disease Control and Prevention estimates that 68.5% of Americans, including 63.9% of adult women older than 20 years, are overweight (body mass index between 25 kg/m2 and 29.9 kg/m2) or obese (body mass index >30 kg/m2). In light of this, it is not surprising that the rates of bariatric surgery have also been increasing. When considering the metabolic changes associated with both bariatric surgery and contraceptive use, in combination with the unique medical considerations of obese women, it is indisputable that clear guidelines are needed when counseling obese patients of reproductive age after bariatric surgery. In this literature review, we focus on depot medroxyprogesterone acetate (DMPA) and the implications of its use in obese women, preweight and postweight loss following bariatric surgery. Both DMPA use and bariatric surgery are known to cause bone loss, but it is still unclear whether there is an additive effect of the two factors on bone loss and whether either of these factors directly leads to an increased risk of bone fracture. The current consensus guidelines do not impose a restriction on the use of DMPA after bariatric surgery. DMPA use is associated with weight gain, and it is unclear whether weight loss blunting occurs with the use of DMPA after bariatric surgery. Prior studies had demonstrated an association with weight gain in adolescents, and therefore, those prescribing DMPA use after bariatric surgery in adolescents should proceed with caution. Adult women do not have a similar response to the use of DMPA. DMPA use has rarely been associated with increased risk of venous thromboembolism (VTE). The obesity-associated increase in VTE should be mitigated by surgically induced weight loss. The concurrent use of DMPA in the post bariatric surgical period should not further increase the risk of VTE.

Obesity and contraception: emerging issues.

Obesity is increasing in prevalence worldwide. Obese women are at similar risk of unintended pregnancy as normal weight women, although limited data are available on the effects of obesity on the efficacy of contraception. Conflicting data exist regarding efficacy of oral contraceptives in obese women, although trends of oral contraceptive failure are no higher than compared with those of normal weight women. The risk of venous thromboembolism is increased with obesity, and this risk may be additive when using a combined hormonal method. Bariatric surgery can lead to increased fertility; postoperative recommendations include avoiding pregnancy in the first year. Contraceptive use patterns in these women are largely unknown. Surgeons need greater awareness of the need for use of effective long-acting methods, and consensus guidelines need to be established.

Same-day initiation of the transdermal hormonal delivery system (contraceptive patch) versus traditional initiation methods.

INTRODUCTION: Published comparisons of oral contraceptive pill (OCP) initiation methods demonstrate that OCP initiation at the office visit ("Quick Start") resulted in higher continuation rates into the second cycle. This trial was performed to investigate whether Quick Start with the contraceptive patch would provide similar results. MATERIALS AND METHODS: Sixty women were randomized to initiate use of the contraceptive patch using Quick Start (Group 1, n=30) or on the first day of their next menses (Group 2, n=30). Telephone contact at 6 weeks occurred to ensure that the second cycle had been initiated. A single follow-up visit was scheduled after completion of the third patch cycle. RESULTS: Continuation rates for Groups 1 and 2 were 97% and 93% (p=1.0), respectively, into the second cycle, and 93% and 90%, respectively, into the third cycle (p=1.0). Only approximately half of the subjects planned to continue using the patch after the study. CONCLUSION: Quick Start for the contraceptive patch did not improve continuation rates into the second or third cycle.

A pilot study of mifepristone and misoprostol administered at the same time for abortion in women with gestation from 50 to 63 days.

INTRODUCTION: In the interest of decreasing the amount of time it takes to achieve a medical abortion, we performed a pilot study to evaluate the simultaneous administration of mifepristone and vaginal misoprostol for women with gestation from 50 to 63 days. MATERIALS AND METHODS: Forty women were enrolled with undesired pregnancies from 50 to 56 days' gestation (group 1) and 40 from 57 to 63 days' gestation (group 2). All women used misoprostol 800 mug vaginally immediately after having swallowed the 200 mg mifepristone tablet. Follow-up evaluations with transvaginal ultrasonography occurred at 24 h and 2 weeks after treatment. RESULTS: The 24-h expulsion rates were 88% (95% CI, 77-98) and 83% (95% CI, 7-94) in groups 1 and 2, respectively. The complete abortion rates at 2 weeks were 93% (95% CI, 84-100) and 90% (95% CI, 81-99), respectively. DISCUSSION: Simultaneous administration of oral mifepristone and vaginal misoprostol provides 24-h expulsion rates in women with gestation from 50 to 63 days, comparable to those reported in the medical literature for standard treatment regimens. Further study of this regimen in a large randomized trial is warranted.

A pilot study of mifepristone and misoprostol administered at the same time for abortion up to 49 days gestation.

HYPOTHESIS: Simultaneous administration of mifepristone and misoprostol for medical abortion in women up to 49 days gestation will result in complete abortion in 90% of women within 24 h of treatment. MATERIALS AND METHODS: Forty women with pregnancies up to 49 days gestation inserted 800 mug vaginal misoprostol in our office immediately after taking mifepristone 200 mg orally. Follow-up visits, which included vaginal ultrasonography, occurred 24+/-1 h and 2 weeks after treatment. If a gestational sac was still present at the first follow-up visit, the misoprostol dose was repeated. Suction abortion was performed for a viable gestation at the second follow-up visit, presence of a nonviable gestation within 5 weeks of treatment and when clinically indicated. RESULTS: Expulsion occurred in 36/40 (90%, 95% CI 80-99) and 39/40 (98%, 95% CI 93-100) women by the first and second follow-up visits, respectively. One woman who had initially expelled the gestational sac after a single dose of misoprostol later required a suction curettage for an incomplete abortion. CONCLUSION: Simultaneous administration of mifepristone and vaginal misoprostol is a promising regimen for medical abortion up to 49 days gestation.

Feasibility study of the use of a daily electronic mail reminder to improve oral contraceptive compliance.

Women who ingest their oral contraceptive pill (OCP) as part of a daily routine are more likely use their OCPs correctly. This trial examines the feasibility of an electronic-mail (e-mail) reminder system to improve OCP compliance. An e-mail reminder was sent to 50 new OCP users daily for 3 months. Subjects sent an e-mail reply to confirm receipt. OCP compliance was recorded on diaries. Four subjects were discontinued for not checking their e-mail. Active participants missed a median of 18% of the e-mail reminders (range: 0-65%). A follow-up visit was scheduled after completion of three OCP cycles. Of the 40 subjects returning completed diaries, 50% missed no active pills at all and 20% missed at least one in each cycle. Most found the daily e-mail somewhat (65%) or very helpful (19%) for OCP compliance. Of those continuing OCPs, 64% wanted to continue receiving e-mail reminders at the completion of the study. Because inconsistent OCP use is a significant cause of unplanned conception, the use of e-mail to improve OCP compliance has the potential to decrease unintended pregnancies.