Michelle C. Fox

A Randomized Comparison of Misoprostol 6 to 8 Hours Versus 24 Hours After Mifepristone for Abortion

OBJECTIVE: To demonstrate equivalence between mifepristone 200 mg followed 6 to 8 hours later and 24 hours later by misoprostol 800 &mgr;g vaginally for abortion in women up to 63 days of gestation. METHODS: Mifepristone 200 mg was swallowed by 1,080 women after which they were randomly assigned to self-administer misoprostol intravaginally 6 to 8 hours later (group 1) or 23 to 25 hours later (group 2) at home. Participants returned for an evaluation, including transvaginal ultrasonography, 7 ± 1 days after initiating treatment. Subjects who had not aborted were offered a second dose of misoprostol. All participants returned approximately 2 weeks after receiving mifepristone. Telephone contact was also attempted approximately 5 weeks after treatment. Treatment was considered a failure if a suction aspiration was performed for any indication. RESULTS: Complete abortion rates for groups 1 and 2 were 503 of 525 (95.8%, 95% confidence interval 93.7%, 97.3%) and 521 of 531 (98.1%, 95% confidence interval 96.6%, 99.1%), respectively, which were statistically equivalent. Side effects were significantly more common after mifepristone administration for women in group 2. Nausea, vomiting, and heavy bleeding were also significantly greater for women in group 2 after misoprostol treatment. Pain and subject acceptability were similar between groups. CONCLUSION: Mifepristone 200 mg followed 6 to 8 hours later by misoprostol 800 &mgr;g vaginally is as effective for abortion and has significantly fewer side effects as compared with regimens using a 24-hour dosing interval. Women receiving mifepristone and vaginal misoprostol for abortion can have the flexibility to administer the misoprostol as soon as 6 hours after using the mifepristone. LEVEL OF EVIDENCE: I

An Open-Label, Randomized, Two-Period Crossover Study of the NuvaRing Applicator in Healthy Women [8N]

INTRODUCTION: NuvaRing®, a contraceptive vaginal ring, is inserted by the user with her fingers. An applicator has been developed as an optional insertion aid. This study assessed performance, tolerability, and safety of a new applicator. METHODS: Women aged 18–45 years not currently using NuvaRing® were enrolled at 2 centers in this 2-period crossover study. Women were randomly assigned to either applicator or fingers in the first period and the other method in the second. For both periods, the ring was in place for 24–72 h; questionnaires were administered immediately following ring insertion and at removal. The second period occurred 48–72 h after removal of the first ring. RESULTS: 164 women (mean age 30.2 years) were randomized: 163 completed the applicator period, 162 completed the fingers period. Insertion was 100% successful with both methods. Ring expulsion occurred in 1 and 2 women, respectively, with applicator and fingers. Among randomized subjects, 8.6% and 4.3%, respectively, reported at least 1 treatment-related adverse event (AE); all were mild and were mostly considered related to the ring rather than the insertion method. Five AEs (4 events [2.5%] of vulvovaginal pain, 1 episode [0.6%] of abdominal cramping) were considered related to the applicator. The 4 AEs of mild pain (eg, “pinching”) lasted less than 1 minute and resolved spontaneously. Bleeding did not occur during or up to 15 h following applicator use; mild events occurred more commonly during follow-up after applicator use (3.1% and 0.6%, respectively). CONCLUSION: The NuvaRing® Applicator is an effective and well-tolerated optional NuvaRing® insertion aid.

Contraceptive needs of human immunodeficiency virus-infected adolescent women: a qualitative analysis.

INTRODUCTION: Adolescents and young adults represent approximately 40% of new human immunodeficiency virus (HIV) infections in the United States. Although knowledge and attitudes regarding family planning methods and use have been described in adult women living with HIV, limited work has focused on adolescents and young adults. METHODS: We conducted semistructured interviews with 10 HIV-positive women aged 13–21 years. The interviews addressed contraceptive knowledge, preferences, experiences, and pregnancy intentions. Qualitative analysis of the interviews was performed using a grounded theory approach. RESULTS: The majority (n=9) of interview participants were perinatally infected with HIV. Five respondents reported ever having been sexually active with three reporting use of hormonal contraception (all used injectable progestin). Only three women were aware of the intrauterine device, and one was aware of the implant as contraceptive options. All expressed a desire for future fertility, and none wanted to conceive right now. Major themes included concerns regarding hormonal contraceptive side effects, the importance of avoiding HIV transmission to a partner or child, and the desire to delay childbearing. Participants frequently identified their HIV care provider as their preferred source of information regarding contraception. CONCLUSIONS: This research demonstrates that young women with HIV have unmet needs for family planning services, and they rely on their HIV care providers for these services. Clinicians specializing in HIV management need to be comfortable providing contraceptive counseling for highly effective methods. Collaboration between HIV care providers and adolescent-friendly family planning service providers is important to prevent unintended pregnancy in this vulnerable group of youth.