Eric A. Schaff

Low-dose mifepristone 200 mg and vaginal misoprostol for abortion

The objectives of this study were to determine the effectiveness, side effects, and acceptability of one-third the standard 600 mg dose of mifepristone (200 mg) to induce abortion. A prospective trial at seven sites enrolled women > or = 18 years, up to 8 weeks pregnant, and wanting an abortion. The women received 200 mg mifepristone orally, self-administered 800 micrograms misoprostol vaginally at home 48 h later, and returned 1-4 days later for ultrasound evaluation. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, persistent products of conception 5 weeks later, or other serious medical conditions. Of the 933 subjects, 906 (97%) had complete medical abortions, 22 had surgical intervention, two were protocol failures, and three were lost to follow up. Of the 746 subjects who had no or minimal bleeding before misoprostol, 80% bled within 4 h and 98% within 24 h of using misoprostol. By day 7, 95% of women had a complete abortion. Side effects were aceptable in 85% of subjects, and 94% found the procedure acceptable. Low-dose mifepristone followed by vaginal misoprostol was highly effective as an abortifacient.

Low-dose mifepristone followed by vaginal misoprostol at 48 hours for abortion up to 63 days

The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, i.e., 200 mg, and vaginal misoprostol 800 microg to induce abortion in subjects < or =56 days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women > or =18 years, < or =63 days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 microg vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the < or =56 days pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up. Complete medical abortions occurred in 97% of subjects < or =56 days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the < or =56 days pregnant and 92% in the 57-63 days pregnant group bled within 4 h of using vaginal misoprostol. Comparing subjects < or =56 days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs 29%, p = 0.002) and vomiting (33% vs 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. One subject in the < or =56 day group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 day group, 91% of subjects in both groups reported that the overall procedure was acceptable. In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 microg at 48 h were highly effective and acceptable to women < or =63 days pregnant, thereby expanding the number of women who can access a medical abortion.

Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion

Mifepristone was recently approved in the United States. Regimens with shorter intervals may be more acceptable. The objective of this study was to determine whether the oral route of misoprostol was as effective as the vaginal route of misoprostol 1 day after mifepristone. A prospective, open-labeled, randomized trial of healthy adult women up to 63 days pregnant and wanting a medical abortion were randomized to use either two doses of oral misoprostol 400 microg taken 2 h apart or misoprostol 800 microg vaginally. Women self-administered misoprostol 1 day after taking one-third of the standard dose of mifepristone (200 mg) orally. Women then returned to the clinic up to 5 days later for a repeat sonogram evaluation. A dose of vaginal misoprostol was administered to women with a continuing pregnancy who then returned 1 day later to Day 15. The primary outcome measures were a complete medical abortion by the first or by the second follow-up visits. Surgical intervention was indicated for continuing pregnancy at the second follow-up visit, excessive bleeding, or persistent products of conception 5 weeks later. One thousand one hundred sixty-eight women were enrolled. Of the 1144 (98%) women who complied with their random assignment, two oral doses of misoprostol (800 microg total) were 90% effective at inducing an abortion by the first follow-up visit, compared with one dose of misoprostol by vagina of 97% (chi(2) = 23.95, p = 0.001). By the second follow-up visit, the complete abortion rate was 95% for oral misoprostol and 99% for vaginal misoprostol (chi(2) = 21.76, p = 0.001). There were minimal differences in side effects. Women preferred the oral route. The trial demonstrated that although two doses of oral misoprostol were effective, the vaginal misoprostol was more effective at inducing an early medical abortion at 1 day after low-dose mifepristone, and the regimen could be extended to 63 days gestation.

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

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.

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 familys 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 womens 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.

Curettage after mifepristone-induced abortion: frequency, timing, and indications

Abstract OBJECTIVE: To characterize women who underwent curettage after medical abortion with mifepristone and vaginal misoprostol, to describe when curettage occurred and the reasons for the intervention, and to categorize the indications for curettage according to a simple classification schema. Methods: These analyses used data from two multisite, randomized controlled trials sponsored by Abortion Rights Mobilization. In the first study, women pregnant less than 63 days received 200 mg of mifepristone and 800 μg of vaginal misoprostol to use 48 hours after taking mifepristone. In the second study, women pregnant less than 56 days were randomly assigned to insert vaginal misoprostol at 1, 2, or 3 days after mifepristone administration. Case report forms and clinical case notes of all women who underwent curettage were examined. Results: Of the 4393 women enrolled in both studies, 116 (2.6%, 95% confidence interval 2.1%, 3.1%) curettages were identified. The gestational age and a history of prior elective abortion were associated with the rate of curettage. The distribution of indications for curettage included bleeding, 61 (53%); continuing pregnancy, 17 (15%); patient request, 36 (31%); and indeterminate, 2 (1.7%). The timing of curettage differed by the indication and scheduled interval between study visits. The distribution of the timing was bimodal. One subset of women, 44 (38%), underwent curettage in the first study week and another subset, 43 (37%), during weeks 3–5. Conclusion: Curettage after medical abortion with mifepristone and vaginal misoprostol is rare. At least one half of the curettages were performed for persistent bleeding several weeks after treatment. Both acute heavy bleeding and continuing pregnancy are extremely rare.

Multicenter trial of a simplified mifepristone medical abortion regimen

OBJECTIVE: To provide evidence regarding the safety, efficacy, and acceptability of 200 mg mifepristone followed by home administration of 400 &mgr;g oral misoprostol METHODS: The 376 women enrolled in this prospective, open-label, multicenter trial were administered mifepristone in the clinic and were given 2 tablets of 200 &mgr;g misoprostol to swallow at home 48 hours later. On day 15, women returned to the clinic for a gynecologic examination. Success was defined as a complete termination without surgical intervention or additional misoprostol by day 21. All participants completed an exit interview before discharge from the study RESULTS: Of the women enrolled, 58.8% had gestations of between 43 and 49 days, 54.7% had had a previous abortion, and 76% had had a previous pregnancy. Of the 354 women included in the efficacy analysis, 324 (91.5%) had a successful termination. The most common adverse effects reported by patients were pain or cramps (93.2%) and nausea (66.6%), followed by weakness (54.7%), headache (46.2%), and dizziness (44.4%). Overall acceptability of the regimen was high, with 63.3% of women reporting that it was very satisfactory and an additional 23% reporting that it was satisfactory CONCLUSION: A regimen of 200 mg mifepristone followed in 48 hours by home administration of 400 &mgr;g oral misoprostol is effective, associated with rare severe adverse effects or adverse events, and acceptable for women seeking medical abortion of pregnancies of up to 49 days duration as compared with the regimen currently approved by the Food and Drug Administration. LEVEL OF EVIDENCE: III

Contraceptive Implant Use Among Inner City Teens

PURPOSES This study develops a clinical profile of urban teens who selected Norplant for contraception; determines which variables identify the subjects most likely to be compliant with the method; and determines the most common reasons for early termination of use. METHODS Demographic and health history data and reasons for termination of use were collected prospectively for 122 inner city teens who received Norplant. Life table analysis and the Mantel-Haenszel procedure were used to investigate differences between Norplant retainers and terminators. RESULTS The sample consisted of black and Hispanic teens between the ages of 13-19 years, the majority of whom had one or more children and were in school. One and two year retention rates were 71% and 62%. The highest removal rates occurred during the 3-6 month interval after insertion. A significant finding was that teens who have experienced induced abortion were more likely to retain Norplant. Common reasons for termination of use included general and social concerns, including pregnancy desire. CONCLUSIONS Norplant retention rates for this teen sample were greater than the compliance rates reported for other conventional methods. Similar to noncompliance with oral contraceptives, discontinuance of the method was most likely to occur in the first 6 months of use. A history of induced abortion identifies those teens most likely to retain Norplant, suggesting that these teens might evaluate contraceptive risks and benefits differently than those with no abortion history. Pregnancy desire was a common reason for terminating Norplant use.

Mifepristone and misoprostol for early abortion when no gestational sac is present

The study was conducted to determine whether the administration of mifepristone followed by vaginal misoprostol can induce an abortion in early pregnancy when no gestational sac is present on sonogram. This report presents a prospective, pilot study of 30 healthy adult women, pregnant and seeking an abortion, and with no gestational sac on sonogram. All women had a baseline serum chorionic gonadotropin (hCG) level measured prior to using mifepristone 200 mg orally followed by misoprostol 800 mcg vaginally 48 h later, and then returned up to 4 days later for a repeat sonogram and serum hCG level. Women with initial hCG levels > 2000 IU/L were evaluated for ectopic pregnancy. At the first follow-up visit, if the hCG decreased by >50%, the women were followed with home pregnancy (25 IU/L) tests weekly until negative. If the levels did not decrease by 50%, a second dose of misoprostol was given. Surgical intervention was indicated for persistent hCG levels or excessive bleeding. Of the 30 women enrolled, the mean number of days of amenorrhea was 40 (SD 9) days. Two women had surgical intervention for continuing pregnancy, 2 had ectopic pregnancies, and 1 was lost to follow-up. Complete medical abortions occurred in 25/30 (88%) women, but when recalculated, in 25/27 (93%) women who completed the protocol and who did not have an ectopic pregnancy. There was 1 adverse event in a woman with an ongoing pregnancy who then received methotrexate. She was hospitalized a day later with a complicated pelvic infection and likely methotrexate-induced pneumonitis. Twenty-three women had a decrease in hCG at first follow-up visit of >50%. All 27 women who completed the protocol found the overall regimen acceptable. Mifepristone followed at 48 h by vaginal misoprostol were effective and acceptable in inducing an abortion in very early pregnancy. There may be a higher incidence of failure in very early pregnancies. Documentation of a complete abortion by hCG level is necessary to ensure the pregnancy is neither ongoing nor ectopic.