Oral contraceptives: does formulation matter?

OCs come in a variety of formulations but verifiable differences between products are difficult to find.

Preventing injuries and illnesses in the wilderness.

Wilderness trips have become increasingly popular, especially in the adolescent population. The wilderness can be a source of rejuvenation while being mentally and physically challenging; however, it is also fraught with the potential for injury, illness, and even death. Epidemiologic studies of injuries and illnesses from hikers are not extensive, but there are sufficient data to identify the most common risk factors to offer some strategies for prevention. Many youth will have a medical visit or preparticipation physical assessment before an organized wilderness experience. This article highlights commonly seen wilderness injuries and illnesses and provides guidance for proper planning and problem solving.

Mifepristone: ten years later.

While pregnant women have sought abortifacients for thousands of years, they had no success at finding one that both worked and did not jeopardize their lives in the process. The discovery of mifepristone, with both anti-glucocorticoid and anti-progesterone properties, has had a profound effect on women's lives while weaving the abortion-related political hazards. Despite the controversies, millions of women around the world have used mifepristone for medical abortion. This review describes how researchers addressed the numerous barriers of a mifepristone abortion (i.e., gestational age limitation, lengthy process, high costs, complex regimen, failures, side effects and complications) and continue to improve upon the limited numbers and types of clinicians offering mifepristone.

Comparison of misoprostol plasma concentrations following buccal and sublingual administration.

BACKGROUND: New indications for misoprostol include medical abortion, cervical softening, induction of labor and treatment of postpartum hemorrhage. Various routes of misoprostol administration under study include oral, vaginal, buccal, sublingual and rectal. MATERIALS AND METHODS: This was an open-label, randomized, cross-over study of the pharmacokinetic differences of buccal vs. sublingual misoprostol 800 mug in 10 healthy women. RESULTS: Of the 10 women enrolled, 2 withdrew after experiencing excessive cramping from the sublingual route of misoprostol. The mean misoprostol plasma concentration-time curves at 4 h [area under the curve (AUC)0-4)] and the maximum concentration (C(max)) showed that levels were significantly higher for sublingual administration than the buccal route. Buccal misoprostol administration resulted in fewer symptoms and was found to be more acceptable. CONCLUSIONS: Sublingual administration of misoprostol had a higher AUC and C(max) compared with buccal administration. The pharmacokinetics may help to determine the best application of misoprostol depending on the indication.

Low-dose mifepristone for contraception: a weekly versus planned postcoital randomized pilot study.

In this randomized pilot study, we compared the contraceptive efficacy, safety and side effect profiles of weekly versus planned postcoital regimens of low-dose mifepristone. Forty participants were randomized to receive mifepristone 10 mg weekly or planned postcoitally (to be used no more frequently than once every 5 days), for 12 consecutive months. Participants were evaluated monthly to determine pregnancy, ovulation status and acceptability of physical side effects. We ended this pilot study prematurely due to low efficacy and predetermined stopping rules. Three pregnancies during 56 woman-months occurred in the weekly group and three pregnancies during 68 woman-months occurred in the planned postcoital group. Almost half of the participants ovulated monthly on either regimen. The majority of the participants found the physical side effects of these regimens acceptable. Participants in the planned postcoital group, however, found adhering to the regimen more difficult than those in the weekly group. Mifepristone 10 mg used weekly or planned postcoitally did not adequately prevent pregnancy in our pilot study population. Although the concept of intermittent low-dose mifepristone is appealing, the contraceptive effectiveness was disappointing.

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 microg 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 microg 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.

Social context and the experience of a sample of U.S. women taking RU-486 (mifepristone) for early abortion.

Of 50 women seeking an abortion in Rochester, New York, between November 1999 and January 2001, 35 went on to complete an in-depth interview from 1 to 6 weeks after their follow-up clinical visit. A higher proportion of women who defined their pregnancy as a baby indicated emotional distress during their in-depth interview compared to those who saw their pregnancy as only having the potential to become a baby. The authors conclude that abortion might be made less difficult through public education about the different views of pregnancy and abortion throughout U.S. history. It might be important for abortion counselors to first ask a woman how she defines her pregnancy. A larger study is warranted.

Randomized trial of oral versus vaginal misoprostol 2 days after mifepristone 200 mg for abortion up to 63 days of pregnancy.

This prospective, open-label, randomized trial of healthy adult women up to 9 weeks pregnant compared mifepristone 200 mg followed 2 days later with misoprostol 400 microg orally versus misoprostol 800 microg vaginally. The study was interrupted after the oral misoprostol group experienced a higher than expected failure rate. This treatment was discontinued and another substituted consisting of oral misoprostol 800 microg divided into two doses two hours apart. Women returned for a follow-up visit from Day 4 to 8. All women with a continuing pregnancy received a repeat dose of misoprostol vaginally and returned before Day 15. The primary outcome measure was a complete medical abortion without surgical intervention at the first visit. Of the 1045 women enrolled, 1011 had complete data: Group 1 (220) used oral misoprostol 400 microg, Group 2 (269) used oral misoprostol 800 microg, and Group 3 (522) used vaginal misoprostol 800 microg. At first follow-up visit, the primary outcome, that is, a complete abortion, was 84% for Group 1, 92% for Group 2, and 96% for Group 3, p < 0.001. After a second dose of vaginal misoprostol in women with on-going pregnancies at their first follow-up visit, the complete abortion rates were 91%, 95%, and 98%, respectively, p < 0.001. There were minimal differences in side effects, onset of bleeding and overall acceptability in the three groups. Mifepristone 200 mg followed by vaginal misoprostol 2 days later was more effective at inducing an abortion up to 9 weeks of pregnancy than the same dose of mifepristone followed by oral misoprostol.

Clinicians' perception of sonogram indication for mifepristone abortion up to 63 days.

One barrier in the US to wider acceptance of mifepristone for abortion is the additional cost of the routine use of two sonograms, that is, for pregnancy dating and confirmation of a complete abortion. The purpose of this study is to document how the accuracy of medical abortion clinicians experienced with pelvic exams and dating pregnancies in assessing gestational age at the first visit compared with sonograms, and to identify the factors influencing whether they perceive that sonograms are desired or indicated at the first and follow-up visits. This was a prospective study of 1016 women wanting to participate in a medical abortion trial. After informed consent, clinicians (1) dated the pregnancy before routine sonography and (2) determined whether a sonogram was indicated. Women with sonographic pregnancies of less than 63 days were eligible for mifepristone followed by misoprostol 48 h later. Women returned on Day 4 to Day 8, and clinicians performed a clinical assessment of whether the abortion was complete and determined whether a sonogram was indicated. Fifteen sites participated. Advanced-level providers performed 56% of the assessments. When clinicians assessed a pregnancy under 43 days gestation, they perceived that a sonogram was "not indicated" in 60% of these women. This percentage increased to 66% at 43-49 days gestation, and declined to 46% of women assessed at more than 49 days. Clinicians correctly assessed gestational age as no more than 63 days in 87% of women. In only 1% (14/1013) of their assessments did clinicians underestimate gestational age. In 7/24 (29%) women with a persistent gestational sac, clinicians did not indicate the need for sonography when it was likely indicated. We conclude that the clinicians in our study felt confident in not using sonography in most cases. If clinicians monitor hCG levels to identify any ectopic or continuing pregnancies, medical abortion can be safely performed without sonography.

Having an abortion using mifepristone and home misoprostol: a qualitative analysis of women's experiences.

CONTEXT: Women choose medical over surgical abortion because it is more natural, more private and less painful. Whether their perceptions change during the medical abortion process has not been explored. METHODS: A nonprobabilitysample of 43 participants in a clinical trial of abortion using mifepristone completed two open-ended questionnaires about this method, one before taking mifepristone and the second during their follow-up clinic visit 4-8 days after taking misoprostol. Thirty women participated in in-depth interviews 1-6 weeks following their abortion. Researchers analyzed transcripts to identify common themes. RESULTS: On the first visit to the clinic, women expressed anxiety and uncertainty about the effectiveness of medical abortion, guilt or ambivalence, and a desire to avoid surgery. For most women, emotional distress decreased after their abortion. Control was the overarching theme women expressed regarding the meaning of the procedure: Women stressed the importance of being able to select the type of abortion procedure, to maintain control over their future and to preserve their family's quality of life, given the constraints of time, finances and emotional resources. In in-depth interviews, eight women remained concerned about long-term health effects; 18 said that having an abortion at home was a comfortable experience. CONCLUSIONS: Learning whether women are concerned about personal control may help clinicians identify appropriate candidates for medical abortion. In addition, clinicians could help allay women's anxiety at their first abortion visit by explaining that the uncertainties posed by any medical procedure create similar feelings. Clinicians also should reemphasize at the follow-up visit that there are no long-term health effects related to abortion.