To determine the outcome and side effects of a new drug protocol to induce abortion.
An urban primary care practice.
One hundred consecutive patients who requested elective termination of pregnancies of less than 8 weeks' gestation.
Subjects received methotrexate (50 mg/m2 body surface area, administered intramuscularly) and, 3 days afterward, misoprostol (800 micrograms, given vaginally).
Number of abortions induced within 24 hours and within 10 days of misoprostol administration, number of surgical aspirations conducted because of incomplete abortion, mean amount of bleeding and pain and the number of women who, if faced with the same situation, said they would again choose a drug-induced abortion over a surgical one.
Abortion occurred within 24 hours of misoprostol administration among 48 women and within 10 days among 69 women. In total, 89 women had an abortion without surgical aspiration. Of these women, 71 said they would choose a drug-induced abortion if faced with the choice again.
Abortion induced with methotrexate and misoprostol appears to be a feasible alternative to surgical abortion and deserves further study.
Cites: Med J Aust. 1971 Nov 20;2(21):1076-75127491
Cites: Am J Obstet Gynecol. 1995 Nov;173(5):1578-847503204
Cites: Cancer. 1976 Feb;37(2 Suppl):1043-7175914
Cites: Am J Med. 1990 Jun;88(6):589-922189302
Cites: Am J Obstet Gynecol. 1990 Jun;162(6):1620-3; discussion 1623-42360595
On July 19, 2005, the Food and Drug Administration (FDA) issued a public health advisory regarding the deaths of four women in the United States after medical abortions with Mifeprex (mifepristone, formerly RU-486; Danco Laboratories, New York, New York) and intravaginal misoprostol. Two of these deaths occurred in 2003, one in 2004, and one in 2005. Two of these U.S. cases had clinical illness consistent with toxic shock and had evidence of endometrial infection with Clostridium sordellii, a gram-positive, toxin-forming anaerobic bacteria. In addition, a fatal case of C. sordellii toxic shock syndrome after medical abortion with mifepristone and misoprostol was reported in 2001, in Canada. All three cases of C. sordellii infection were notable for lack of fever, and all had refractory hypotension, multiple effusions, hemoconcentration, and a profound leukocytosis. C. sordellii previously has been described as a cause of pregnancy-associated toxic shock syndrome.
Misoprostol can be used in the prevention of gastric ulcer in treatment with diclofenac and is used in rheumatic diseases. Since misoprostol causes contractions of the uterus, it can also be used to induce abortions when administrated vaginally. The aim of the study was to investigate if early pregnancy exposure to oral diclofenac/misoprostol was associated with miscarriage.
We conducted a nationwide cohort study identifying all registered pregnancies in Denmark from 1997 to 2011. All births were identified using the Medical Birth Registry, and all records of induced abortion and miscarriage were from the National Hospital Register. Data on drug use were from the National Prescription Register. Cox proportional hazard regression models were used to calculate the hazard of miscarriage in women exposed to diclofenac/misoprostol in early pregnancy.
We identified 1,338,824 pregnancies (970,491 births, 142,147 miscarriages, 226,145 induced abortions). One hundred sixty-six were exposed to diclofenac/misoprostol in the early pregnancy of which 28.3 % (47) ended up in a miscarriage compared to 10.6 % among unexposed. The adjusted hazard ratio of having a miscarriage after exposure to diclofenac/misoprostol in the first trimester was 3.6 (CI 95 % 2.6-4.9).
We found an increased risk of miscarriage after exposure to diclofenac/misoprostol during the early pregnancy. Women in the fertile age should not be treated with the combination of diclofenac/misoprostol if other options were available.
This study assessed the efficacy and side effects of first trimester medical abortion using mifepristone and vaginally administered misoprostol. Medical abortion was first introduced in Denmark in December 1997, and the acceptability of this new approach in a Danish population was evaluated. The study included the first 100 women seeking medical abortion. The gestational age was from 33 to 56 days. All received 600 mg mifepristone (RU 486) orally followed 2 days later by vaginally administered misoprostol 400 microg. Success was defined as achieving complete abortion without the need for surgical evacuation. Ninety-three percent achieved a successful medical termination of pregnancy. Side effects were few, and the acceptability was high. Ninety percent of the women would prefer medical abortion in case of a new unwanted pregnancy. The combination of mifepristone and vaginally administrated misoprostol is effective, safe, has few side effects and is well accepted by Danish women.
OBJECTIVE: To test the feasibility, safety, and efficacy of home use of two doses of misoprostol for medical abortion (MA) in European settings. METHODS: One hundred thirty women (100 in Sweden, 30 in France) presenting for first-trimester MA were administered oral mifepristone in the clinic and sent home with two 400 microg doses of misoprostol, along with instructions to take the misoprostol at 24 h intervals. Women were also asked to complete a daily symptom diary. Outcomes of interest included effectiveness, side-effects, and adherence to and acceptability of the home-use regimen. RESULTS: Three women (all in France) were lost to follow-up. Of the remaining 127 women, 124 (98%) had a successful MA. All women adhered successfully to the home-use regimen, and satisfaction with home use was high (98%). Most women experienced noticeable, if transitory, side effects after both the first and second doses of misoprostol (97% and 94%, respectively). CONCLUSIONS: Misoprostol may successfully and satisfactorily be used at home as part of a MA regimen in European settings as it has been for years in the US. Further research to determine if two doses of misoprostol are more effective than a single dose would be useful.
BACKGROUND: Medical abortion was first introduced in Norway in April 1998. The aim of this study is to assess the efficacy, side effects and acceptability of medical abortion with mifepristone and vaginally administered misoprostol in a Norwegian population. MATERIALS AND METHODS: The study included the first consecutive 226 women with gestational age of
Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to manage arthritis. While controlling symptoms and improving quality of life, NSAID use is associated with gastroduodenal injury and a 2%-4% annual risk for symptomatic gastroduodenal ulceration, hemorrhage, and perforation. This requires clinicians to balance the efficacy of NSAIDs against the potential risk of serious gastrointestinal events. Identification and stratification of risk can help guide the optimal approach for arthritis management of individual patients or large populations such as managed care organizations. NSAID-induced gastroenteropathy carries considerable economic consequences; 46% of arthritis costs are related to managing serious adverse events. It is reasonable to assume that these costs may not be incurred if high-risk patients are recognized and optimally managed. Newer therapies with proven safety margins present an attractive option, especially for patients at higher risk. The single-tablet formulations of diclofenac and misoprostol (Arthrotec) offer an alternative in managing NSAID patients because of their inherent safety profile. Studies with diclofenac/misoprostol indicate its effectiveness in treating signs and symptoms of arthritis and in reducing the incidence of NSAID-induced gastroenteropathy. As such, this agent may provide improved medical and economic outcomes. This review discusses the clinical aspects of NSAID-induced gastroenteropathy, including available preventive therapies. Approaches to assessing patients' risk for developing complications, and the relationship of medical risk and economic outcomes, are also examined. Although not all patients require preventive therapy, patients with heightened risk may benefit clinically and economically from gastroprotective NSAIDs. Additional research or modeling may provide further insight into the economic implications of managing and preventing NSAID-induced gastroenteropathy.
OBJECTIVES: To study if misoprostol 400 microg, administered vaginally, increased the successful resolution of early miscarriage compared with placebo. DESIGN: Randomised, double blind placebo controlled study. SETTING: Sahlgrenska University Hospital, Göteborg, Sweden. SAMPLE: One hundred and twenty-six women seeking medical attention for early miscarriage. METHOD: Women with a non-viable, first trimester miscarriage were randomised to vaginal administration of misoprostol 400 microg or placebo. MAIN OUTCOME MEASURES: Main outcome measure was the proportion of successful complete resolution of miscarriage. Secondary outcomes were incidence of infection, bleeding, gastrointestinal side effects, pain, use of analgesics and length of sick leave between groups. RESULTS: Sixty-four patients were randomised to misoprostol and 62 to placebo. Eighty-one percent in the misoprostol and 52% in the placebo group had a complete miscarriage within one week of the primary visit (RR 1.57; 95% CI 1.20-2.06). Patients in the misoprostol group reported more pain as assessed on a visual analogue scale (60.4 [31.0] vs 43.8 [37.1] mm; P
Off-label use of the prostaglandin-E1 analogue misoprostol has become standard practice when inducing labour. In Denmark, a low-dosage misoprostol regimen is common. The regimen consists of one 25 µg application on the first day of induction. The registered prostaglandin-E2 analogue dinoprostone is used in 3 and 6 mg doses. This study compared induction procedures with dinoprostone and misoprostol in terms of induction time, foetal outcome and maternal outcome.
This retrospective study included 1,645 induced deliveries from two periods: 2003-2005, when dinoprostone was standard treatment (n = 635), and 2008-2010, when misoprostol was standard treatment (n = 633). We evaluated the induction method, outcomes and confounders using Kaplan-Meier, Cox and logistic regression analyses.
In the first 24 h, 38% and 59% of women delivered in the misoprostol and dinoprostone groups, respectively. Compared with dinoprostone, misoprostol was associated with a longer induction time (hazard ratio = 0.79, 95% confidence interval (CI): 0.69-0.90). Both regimens showed similar risks of caesarean section (odds ratio (OR) = 0.88, 95% CI: 0.64-1.12), rates of meconium-stained amniotic fluid (OR = 0.85, 95% CI: 0.63-1.15), 5-min Apgar scores