Clostridium sordellii infection in medical abortion.
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Abortifacient Agents↗
Biomedical subjects
Beverly Winikoff
Publications and source records attributed to Beverly Winikoff.
Mifepristone medical abortion in Albania: results from a pilot clinical research study.
OBJECTIVE: To explore the acceptability and feasibility of introducing mifepristone-misoprostol for early medical abortion in home and clinic settings in Albania. METHODS: This was a prospective study testing a simplified mifepristone-misoprostol regimen in two tertiary-level government health facilities in Tirana, Albania. Women (n = 409) with amenorrhea of 8 weeks or less received 200 mg mifepristone in the clinic and then chose whether to take 400 microg of oral misoprostol 2 days later either at home or in the clinic. RESULTS: Nearly 97% of women successfully terminated their pregnancies using the simplified regimen. Almost all women found the method either satisfactory (49.4%) or highly satisfactory (41.1%). Almost all women who were given the option selected the home use protocol. Women choosing home administration of misoprostol were able to manage the medical abortion process on their own. CONCLUSION: A reduced dose mifepristone medical abortion regimen with home administration of misoprostol is feasible for introduction into healthcare facilities in Albania.
Abortifacient Agents, Steroidal↗
Pregnancy failure and misoprostol--time for a change.
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Abortifacient Agents, Nonsteroidal↗
Randomized trial of mifepristone and buccal or vaginal misoprostol for abortion through 56 days of last menstrual period.
OBJECTIVE: Mifepristone-misoprostol medical abortion has been approved in the United States since 2000. U.S. providers have preferred to use vaginal misoprostol because of evidence that such a regimen is more effective in later gestations. Buccal administration of misoprostol may be equally effective and more acceptable to some women. METHODS: This open-label, randomized trial was conducted at two sites in Rochester, NY, and involved healthy women with pregnancies through 56 days since the last menstrual period (LMP) as indicated by sonogram. Women received mifepristone 200 mg orally and were randomized to use 800 mug of misoprostol either buccally or vaginally 1 to 2 days later. They returned within 15 days for repeat sonogram. If the woman's pregnancy had not been completely aborted by day 36, a suction abortion was performed. The primary outcome was a complete abortion without surgical intervention. RESULTS: Four hundred forty-two women were enrolled in the study, and complete data were available on 429. The efficacy rate was 95% (205/216) in the buccal group and 93% (199/213) in the vaginal group (chi(2)=0.43, p=.51). Nausea was the most commonly reported side effect, affecting 70% in the buccal group and 62% in the vaginal group. There were no differences in the satisfaction with the overall procedure between the buccal (92%) and the vaginal groups (95%) (chi(2)=1.87, p=.17). CONCLUSION: Buccal administration of misoprostol after low-dose mifepristone for medical abortion appears to be a highly effective and acceptable alternative compared with vaginal administration for medical abortion in pregnancies through 56 days LMP.
Abortifacient Agents, Nonsteroidal↗
A randomized controlled study comparing 600 versus 1,200 microg oral misoprostol for medical management of incomplete abortion.
OBJECTIVES: Although a number of studies have shown misoprostol's promise as a nonsurgical treatment for incomplete abortion, few have systematically examined treatment protocols. This study documents the effectiveness of 600 versus 1,200 microg oral misoprostol for this indication. METHODS: From May 2002 to January 2003, 300 women with incomplete abortion were recruited at a large tertiary facility in Vietnam and randomized to either a single-dose (600 microg) or a repeated-dose (600 microg x 2) regimen of oral misoprostol for the treatment of their condition. RESULTS: Misoprostol effectively evacuated the uterus for nearly all women (94.6%; n=279), with most reporting bleeding for 4 days (+/-2.3) and pain/cramps lasting 1 day (+/-1.0). Women indicated that the side effects were tolerable (96%) and that their experience was satisfactory (95%). CONCLUSIONS: Oral misoprostol (600 or 1,200 microg) offers a safe, effective and acceptable treatment for incomplete abortion. Larger studies to assess the advantages and disadvantages of misoprostol as compared with standard surgical care are needed to assess its role in postabortion care programs worldwide.
Abortifacient Agents, Nonsteroidal↗
[To the editor].
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Databases, Bibliographic↗
Misoprostol alone for early abortion: an evaluation of seven potential regimens.
INTRODUCTION: A growing body of literature has shown that misoprostol alone could be effective for early medical abortion. We evaluated seven potential regimens in women up to 56 days of gestation in order to potentially identify an optimal regimen. METHODS: In phase I of the study, women requesting early abortion were randomized to one of three misoprostol regimens (4x400 microg po every 3 h, 2x800 microg po every 6 h, 1x600 pv microg); in phase II, women were randomized to one of two regimens (2x800 microg po every 3 h, 1x800 pv microg). In phase III, we consecutively tested two regimens (800 microg pv wetted with saline repeated after 24 h if intact gestational sac, 2x800 microg pv wetted with saline) to validate previously published results. RESULTS: Although most women experienced some side effects, all regimens were tolerable and acceptable. Five of the seven regimens resulted in complete abortion rates of 60% or less. Only repeated doses of 800 microg pv misoprostol resulted in efficacy exceeding 60%. DISCUSSION: Misoprostol-alone abortion regimens using oral misoprostol are too ineffective for clinical use or further investigation. Regimens with repeated dosing of misoprostol 800 microg pv warrant further study to find the optimal treatment protocol.
Abdominal Pain↗
Medical abortion: the possibilities for introduction in the public sector in South Africa.
Medical abortion is safe and effective and has been approved for use in early termination of pregnancy in South Africa since 2001. The Department of Health is currently considering its introduction in the public health sector. The attitudes of women seeking abortion and of health care providers towards medical abortion have not previously been described. Data were derived from a quantitative survey of 673 women attending abortion services in the provinces of Gauteng, Mpumalanga and the Western Cape. In-depth interviews in Soweto and Cape Town were conducted with 20 public health doctors, nurses, a social worker and facility managers, and in Cape Town with four provincial policymakers. Although medical abortion was not yet being offered, 21% of women interviewed were early enough in pregnancy (eight weeks or less) to be eligible for medical abortion. Access to health facilities, including those for abortion, was reasonable for urban women but more limited for rural women. Rural women also incurred greater travel costs to reach a facility. Most women thought medical abortion would be acceptable and would have been willing to try it, had it been available. Policymakers and providers were supportive, as they felt medical abortion could relieve the burden on current services. How to increase access to abortion services in rural areas needs to be addressed.
Abortifacient Agents↗
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 mug 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 mug 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 mug 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.
Abortion, Therapeutic↗
A randomized trial of misoprostol compared with manual vacuum aspiration for incomplete abortion.
OBJECTIVE: To compare the safety, efficacy, and acceptability of misoprostol and manual vacuum aspiration for the treatment of incomplete abortion in a hospital setting in Kampala, Uganda. METHODS: Three hundred seventeen women with clinically diagnosed incomplete first-trimester abortions were randomized to treatment with either manual vacuum aspiration or 600 mug misoprostol orally to complete their abortions. All women received antibiotics posttreatment and were followed up 1-2 weeks later. RESULTS: Regardless of treatment allocation, nearly all women in this study successfully completed their abortions with either oral misoprostol or manual vacuum aspiration (96.3% versus 91.5%, relative risk 1.05, 95% confidence interval 0.98-1.14). Complications were less frequent in those receiving misoprostol than those having manual vacuum aspiration (0.9% versus 9.8%, relative risk 0.1, 95% confidence interval 0.01-0.78). In the 6 hours after treatment, women using misoprostol reported heavier bleeding but lower levels of pain than those treated with manual vacuum aspiration. Rates of acceptability were similarly high among women in the 2 treatment groups, with 94.2% and 94.7% of women reporting that their treatment was satisfactory or very satisfactory in the misoprostol and manual vacuum aspiration groups, respectively. CONCLUSION: For treatment of first-trimester uncomplicated incomplete abortion, both manual vacuum aspiration and 600 microg oral misoprostol are safe, effective, and acceptable treatments. Based on availability of each method and the wishes of individual women, either option may be presented to women for the treatment of incomplete abortion. LEVEL OF EVIDENCE: I.
Abortifacient Agents, Nonsteroidal↗
Misoprostol in the management of the third stage of labour in the home delivery setting in rural Gambia: a randomised controlled trial.
OBJECTIVE: To assess the effectiveness of 600 microg oral misoprostol on postpartum haemorrhage (PPH) and postpartum anaemia in a low income country home birth situation. DESIGN: Double blind randomised controlled trial. SETTING: Twenty-six villages in rural Gambia with 52 traditional birth attendants (TBAs). SAMPLE: One thousand, two hundred and twenty-nine women delivering at home under the guidance of a trained TBA. METHODS: Active management of the third stage of labour using three 200-microg misoprostol tablets and placebo or four 0.5-mg ergometrine tablets (standard treatment) and placebo. Tablets were taken orally immediately after delivery. MAIN OUTCOME MEASURES: Measured blood loss, postpartum haemoglobin (Hb), difference between Hb at the last antenatal care visit and three to five days postpartum. RESULTS: The misoprostol group experienced lower incidence of measured blood loss > or =500 mL and postpartum Hb <8 g/dL, but the differences were not statistically significant. The reduction in postpartum (compared with pre-delivery) Hb > or = 2 g/dL was 16.4% with misoprostol and 21.2% with ergometrine [relative risk 0.77; 95% confidence interval (CI) 0.60-0.98; P= 0.02]. Shivering was significantly more common with misoprostol, while vomiting was more common with ergometrine. Only transient side effects were observed. CONCLUSIONS: Six hundred micrograms of oral misoprostol is a promising drug to prevent life-threatening PPH in this setting.
Abortifacient Agents, Nonsteroidal↗
Incidence of postpartum infection after vaginal delivery in Viet Nam.
This study assessed the incidence of postpartum infection which is rarely clinically evaluated and is probably underestimated in developing countries. This prospective study identified infection after vaginal delivery by clinical and laboratory examinations prior to discharge from hospital and again at six weeks postpartum in Ho Chi Minh City, Viet Nam. Textbook definitions, physicians' diagnoses, symptomatic and verbal autopsy definitions were used for classifying infection. Logistic regression was used for determining associations of postpartum infection with socioeconomic and reproductive characteristics. In total, 978 consecutive, eligible consenting women were followed up at 42+/-7 (range 2-45) days postpartum (not associated with incidence). Ninety-eight percent took 'prophylactic' antibiotics. The most conservative estimate of the incidence of postpartum infection was 1.7%. The incidence of serious infection was 0.5%, but increased to 4.6% when verbal autopsy and symptomatic definitions were used. Postpartum infection, particularly serious infection, is greatly underestimated. Just preventing or treating infection could have a substantial impact on reducing maternal mortality in developing countries.
Adolescent↗
Accounting for time: insights from a life-table analysis of the efficacy of medical abortion.
OBJECTIVE: Previously published analyses have ignored the temporal nature of medical abortion and calculated effectiveness as the proportion of abortions that succeed. By using life tables, we incorporate the important element of time to produce unbiased efficacy rates as well as afford insight into the medical abortion process. STUDY DESIGN: Using data on 6568 women from 6 previously published mifepristone-misoprostol medical abortion studies, we generated multidecrement life table efficacy curves and evaluated the cumulative probability of successful medical abortion. RESULTS: Efficacy rates calculated using proportions are biased because of loss to follow-up. Compliance with the medical abortion regimen was high. More than 80% of abortions were complete within a week of receiving mifepristone. Success continued to improve thereafter. Most surgical interventions were unnecessary. CONCLUSION: Follow-up visits can be scheduled within a week of receiving mifepristone; however, aspirations should not be performed routinely if the abortion is not complete.
Abortifacient Agents↗
The medical abortion experiences of married and unmarried women in Tunis, Tunisia.
CONTEXT: The study explores the social dimensions of abortion in Tunisia and offers evidence supporting the provision of medical abortion to special populations, such as young and unmarried women. METHODS: For this study we recruited 222 women (unmarried: n = 101, married: n = 121) at three clinics in Tunis, Tunisia, from April 1999 to March 2001. All eligible women who consented to participate were administered a simplified regimen of medical abortion consisting of 200 mg oral mifepristone + 400 microg oral misoprostol 2 days later either at home or in the clinic. RESULTS: Our results demonstrate that unmarried women (94.8%) are as likely as married women (94.1%) to have a successful abortion using this regimen. We noted a strong initial preference for home administration of misoprostol among both groups (unmarried: 73.3%, married: 80.2%), which grew even stronger after the procedure. Women indicated that home administration is desirable because transportation to the clinic is expensive (32.7%), home administration is more confidential (26.3%), easier and more convenient (12.8%). Both groups expressed a high degree of satisfaction with the method. CONCLUSIONS: Medical abortion with the option of home administration of misoprostol is safe and feasible for special populations; such as unmarried women in Tunisia.
Abortifacient Agents↗
Differences in efficacy, differences in providers: results from a hazard analysis of medical abortion.
Sample sizes of even the largest medical abortion trials are generally not adequate to provide an understanding of how well the regimen works for subgroups of women, particularly when controlling for factors known to influence efficacy, such as gestational age. By pooling data from four previously published studies of medical abortion and using hazard analyses, we can undertake such an investigation. We find that women with lower gestational ages, women younger than 23 years of age, women with more than 12 years of education and women with no previous induced abortion experience were more likely to experience a successful medical abortion. After taking into account demographic factors, we find that significant differences in efficacy persist across study sites, indicating that differences in providers' tendency to intervene by performing vacuum aspiration vary across medical abortion providers.
Abortifacient Agents, Nonsteroidal↗
Comparative study between single dose 600 microg and repeated dose of oral misoprostol for treatment of incomplete abortion.
OBJECTIVE: To evaluate and compare the effectiveness and side effects of two regimens of oral misoprostol, single dose (600 microg) and repeated dose (1200 microg), in the treatment of incomplete abortion. METHODS: A prospective randomized controlled trial was conducted. One-hundred women who had incomplete abortion (gestational age < 20 weeks) and consented to randomization by computer-generated randomization model prior to treatment. A single oral 600-microg dose or repeated oral dose after 4 h (total 1200 microg) was given to the randomized women. RESULTS: The overall incidence of complete abortion was 86.9%. This incidence was not statistically different between the single-dose and repeated-dose groups (81.6% vs. 92%, p > 0.05). However, there was a significantly decreased incidence of diarrhea (18.4% vs. 40%, p < 0.05) with the use of single-dose treatment. Overall rate of acceptability and tolerable side effects were 88.9% and 97.9%, respectively. These rates were similar in both groups (87.8% vs. 90% and 98% vs. 98%, p > 0.05). CONCLUSIONS: Oral misoprostol may be a practical alternative in the management of incomplete abortion. Oral misoprostol is acceptable and tolerable to women. Single-dose regimen is as effective as repeated-dose regimen, with a reduction in the incidence of diarrhea.
Abortifacient Agents, Nonsteroidal↗
Infection after medical abortion: a review of the literature.
Medical abortion regimens have become widely used, but the frequency of infection after medical abortion is not well documented. This systematic review provides data on infectious complications after medical abortion. We searched Medline for articles written before July 2003 to determine the frequency of infection after medical abortion up to 26 weeks of gestation. We reviewed all articles and extracted data on the frequency of infection from 65 studies. The frequency of diagnosed and/or treated infection after medical abortion was very low (0.92%, N = 46,421) and varied among regimens. Results of this review confirm that, with respect to infectious complications, medical abortion is a safe and effective option for first- and second-trimester pregnancy termination. After accounting for regional variations in diagnosis, there is little difference in frequency of infection among the regimens reviewed. Future studies should report clear diagnosis and treatment standards for infection so that more precise information becomes available.
Abortion, Induced↗
Results and lessons learned from a small medical abortion clinical study in Turkey.
This article presents results from a small, introductory clinical study offering a simplified regimen medical abortion to women in Turkey. A total of 208 women from five sites were recruited from July 2000 through March 2001. All eligible consenting women were given 200 mg oral mifepristone at the clinic followed by 400 microg oral misoprostol 2 days later either at home or at the clinic. The overall success rate of 84.1% is lower than in previous studies of this regimen, and a surprisingly high proportion of women (9.1%) were diagnosed with incomplete abortion. In spite of the higher than expected failure rate, women expressed a high degree of satisfaction. Several challenges were faced during this study, providing valuable insights about ways to introduce medical abortion into new settings with the best chances for success.
Abortifacient Agents, Nonsteroidal↗