misoprostol and Amenorrhea

The objective of this study was to determine if a repeat dose of misoprostol following mifepristone or a single dose of misoprostol increases the efficacy of medical termination of pregnancy.. Randomised, placebo controlled trial.. K.E.M. Hospital, Pune, India, and the Health Centre, Larsen and Toubro Limited, Mumbai, India.. A total of 300 women seeking an abortion with amenorrhoea of 8 weeks or less. Methods Women were randomised to receive one or two doses of 400 microgram oral misoprostol at the clinic 48 hours after administration of 200 mg mifepristone. Main outcome measure Complete abortion without surgical intervention. Results The repeat administration of misoprostol 400 microgram improved the complete abortion rate from 86 to 92% and significantly reduced the rate of continuing pregnancy from 7 to 1%. Almost all the women who were administered the additional dose of misoprostol were either very satisfied (58%) or satisfied (37%) with the method. Conclusion While an additional oral dose of 400 microgram misoprostol did not significantly increase the rate of complete abortion without surgical intervention, the additional dose did significantly reduce the rate of continuing pregnancies without compromising the acceptability and ease of use of the method.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Adult; Amenorrhea; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Humans; Mifepristone; Misoprostol; Patient Satisfaction; Pregnancy; Treatment Outcome

To compare the side effect profiles of regimens of oral and vaginal administration of misoprostol after a single oral dose of 200 mg of mifepristone and to investigate patients' perceptions of medical abortion.. Double-blind, randomised controlled trial.. Fifteen gynaecological clinics in 11 countries.. A total of 2219 healthy pregnant women requesting medical abortion with < or =63 days of amenorrhoea. Two thousand women were asked about their perceptions of the method.. Mifepristone 200 mg orally on day one, followed by 0.8 mg misoprostol either orally or vaginally on day three. The oral group (O/O group) and one of the vaginal groups (V/O group) continued with 0.4 mg of oral misoprostol, and the vaginal-only group (V-only group) with oral placebo, twice daily for seven days. Side effects were recorded daily by women and reported at each visit. After misoprostol administration at the clinic, side effects were recorded at 1-hour interval up to 3 hours. Patients' perceptions were asked at the second follow up visit, six weeks after treatment.. The outcome measures were the following: pregnancy-related symptoms (nausea, vomiting, breast tenderness, fatigue, dizziness, headache), drug-related side effects (diarrhoea, fever, rash and blood pressure change), side effects related to the abortion process (lower abdominal pain) and women's perceptions of the method.. The pregnancy-related symptoms decreased in all groups after misoprostol, and breast tenderness decreased already after mifepristone. Oral administration of misoprostol was associated with a higher frequency of nausea and vomiting than vaginal administration at 1 hour after administration. With oral misoprostol, diarrhoea was more frequent at 1, 2 and at 3 hours after administration than with vaginal administration. Misoprostol induced fever during at least 3 hours after administration in up to 6% of the women, this peak being slightly higher and taking place later with the vaginal route. Lower abdominal pain peaked at 1 and 2 hours after oral misoprostol, while it did so at 2 and 3 hours after vaginal misoprostol. In the two groups that continued misoprostol, 27% of women had diarrhoea between the misoprostol visit and the two-week follow up visit, compared with 9% in the placebo group. Among the women studied, 84% would choose medical abortion again, 9% would choose surgical abortion and 7% did not know. Twenty-three percent of the women would choose to have a possible future abortion at home, 70% at a health facility and 7% did not know.. The pregnancy-related symptoms decrease significantly with time during medical abortion. Nausea, vomiting and diarrhoea were more frequent after oral administration of misoprostol. Pain related to the abortion process occurs earlier after oral misoprostol. Should a need arise, a majority of women would choose medical abortion again and would prefer to have it at a health facility rather than at home.

Topics: Abdominal Pain; Abortifacient Agents, Steroidal; Abortion, Induced; Amenorrhea; Analgesics; Dizziness; Double-Blind Method; Fatigue; Female; Headache; Humans; Mifepristone; Misoprostol; Nausea; Parity; Patient Satisfaction; Perception; Treatment Outcome; Vomiting

To compare the efficacy of oral and vaginal administration of misoprostol after a single oral dose of 200 mg of mifepristone and to investigate whether the efficacy can be improved and the duration of bleeding shortened by continuing oral misoprostol for one week.. Double blind, randomised controlled trial.. Fifteen gynaecological clinics in 11 countries.. A total of 2219 healthy pregnant women requesting medical abortion with < or =63 days of amenorrhoea.. Mifepristone 200 mg administered orally on day one, followed by 0.8 mg misoprostol either orally or vaginally on day three. The oral group and one of the vaginal groups continued with 0.4 mg of oral misoprostol twice daily for seven days.. Complete abortion was the main outcome. Secondary outcomes were side effects, timing of expulsion and duration of bleeding.. The crude complete abortion rate was 92.3% in the oral plus continued oral misoprostol group, in the vaginal-only group it was 93.5%, and it was 94.7% in the vaginal group that continued with oral misoprostol, when considering undetermined cases as failures. Among women with amenorrhoea length > or =57 days, the risk of failure of complete abortion was almost three times higher in the oral plus continued oral misoprostol group (RR = 2.8, 95% CI 1.3 to 5.8), and over two times higher in the vaginal-only group (RR = 2.2, 95% CI 1.0 to 4.7), when compared with the vaginal plus continued oral misoprostol group. Among women with amenorrhoea length < 57 days, the differences were not significant. Timing of expulsions and duration of bleeding were similar in the three groups.. For amenorrhoea length > or =57 days, vaginal misoprostol is more effective than oral when continued with 0.4 mg oral misoprostol twice daily for seven days. Misoprostol continuation improved the efficacy in this amenorrhoea group compared with a single dose of vaginal misoprostol on day three, but it did not shorten the duration of bleeding. No differences in efficacy were observed when amenorrhoea length was < 57 days.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Administration, Oral; Adult; Amenorrhea; Double-Blind Method; Female; Humans; Mifepristone; Misoprostol; Pregnancy; Risk Factors; Treatment Outcome

The efficacy and tolerability of mifepristone in combination with misoprostol for termination of early pregnancy (up to 49 days of amenorrhea) are established. We studied the efficacy and tolerability of this combination therapy for termination of pregnancy in women up to 63 days of amenorrhea. We also examined the effect of an additional dose of misoprostol in cases of nonexpulsion within 3 hours after the first dose. The multicenter trial included 1,108 women, mean age 27.9 +/- 6.2 years. The mean duration of pregnancy was 51.7 +/- 9.2 days. On day 1, the women received an oral dose of mifepristone, 600 mg. On day 3, they received an oral dose of misoprostol, 400 micrograms, and were monitored for up to 3 hours. If they did not expel the conceptus within 3 hours, an additional dose of 200 micrograms of misoprostol was given and they were monitored for 2 more hours. From days 10 to 18, the women were followed up with clinical examination, human chorionic gonadotropin measurement, or ultrasound examination. Overall, the procedure was successful in 92.9% of women. Efficacy decreased with the duration of pregnancy, especially after 56 days of amenorrhea. Up to 42 days of amenorrhea, the success rate was 97.6%; between days 42 and 49, 94.8%; between days 50 and 56, 93.4%; between days 57 and 63, 86.8%; and after day 63, 83.3%. The most common side effects were moderate uterine cramps (80.5%) and gastrointestinal (GI) symptoms (34.9%), especially vomiting (18.3%) and diarrhea (10.5%). GI symptoms were generally mild. A second dose of misoprostol was given to 61.6% of the women. In a subgroup analysis, we assessed the efficacy of 600 mg of mifepristone plus 400 or 600 micrograms of misoprostol (one or two doses) in women with up to 49 days of amenorrhea and compared it with the efficacy in women who received mifepristone plus only 400 micrograms (one dose) of misoprostol in a previous study. The overall rate of success (termination of pregnancy) was 95.5% in the current study compared with 95.4% in the previous study. The additional dose of misoprostol did not significantly increase the overall rate of success, but did increase the rate of termination within the monitoring period (69.7% versus 64.9% (and within 72 hours after administration of mifepristone (92.7% versus 90.4%). We have confirmed that the combination of mifepristone and misoprostol was effective, safe, and well tolerated for termination of pregnancies at 49 or fewer days of amenorrhea. The effi

Topics: Abortifacient Agents; Adolescent; Adult; Amenorrhea; Chorionic Gonadotropin; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; France; Hemostatic Techniques; Humans; Incidence; Menstruation-Inducing Agents; Mifepristone; Misoprostol; Pregnancy; Pregnancy, Ectopic; Time Factors; Ultrasonography; Uterine Hemorrhage; Uterus

To assess, in real-life conditions, the success rate of the protocol mifepristone 600 mg / prostaglandin analogue (PG) in women requesting medical termination of pregnancy (MToP) either up to or beyond 7 weeks of amenorrhea (WA).. The study was performed between 2015 and 2016. This was a non-interventional prospective, multicentre, longitudinal study conducted in France, among a sample of public and/or private centres dealing with MToP. Characteristics of women, term of Mtop, modality of PG used were reported. The primary outcome was success of MToP, defined as complete abortion without surgical procedure.. A total of 893 pregnant women with less than the legal term of 14 WA were included in this study: 490 (54.9 %) ≤7 WA and 403 (45.1 %) >7 WA comprising 29 > 9 WA. The mean age of women was 28.1 ± 6.8 years and the one of pregnancy was 7.0 WA ± 1.3 WA. The most frequently used PG combined to mifepristone 600 mg was misoprostol 400 μg (57.0 % ≤7 WA and 35.1 % >7 WA) or 800 μg per os (oral or oral transmucosal) (27.5 % ≤7 WA and 40.1 % >7 WA). Vaginal misoprostol (6.4 %, N = 48) and gemeprost (5.2 %, N = 39) were less used. In women ≤7 WA (N = 422) and women >7 WA (N = 354) for whom result of the MToP was collected, success rates were 94.5 % (95 %CI 91.9 %-96.5 %) and 92.4 % (95 %CI 89.1 %-94.9 %), respectively (p = 0.219). In multivariate regression analysis, three factors were significantly associated with a higher risk of MToP failure: increased number of previous pregnancies (OR = 1.233; 95 %CI 1.086-1.401 for one pregnancy), increased number of previous surgical ToPs (OR = 1.563; 95 %CI 1.036-2.359 for one ToP) and increased interval between mifepristone and PG intake (OR = 1.061; 95 %CI 1.012-1.112 for one hour). Term of pregnancy (OR = 1.497; 95 %CI 0.833-2.690 for ≤7 WA vs >7WA), administration route (OR = 1.553; 95 %CI 0.488-4.936 for oral vs oral transmucosal; and OR = 1.216; 95 %CI 0.625-2.366 for vaginal vs oral transmucosal), and dose of misoprostol (OR = 1.000; 95 %CI 0.999-1.001), were not associated with the risk of failure. Overall, tolerance was good.. This study showed, in real-life settings, a high rate of success for MToP using mifepristone 600 mg, independent of the pregnancy term and the therapeutic protocol used. MToP was safe and well tolerated however only a small number of women beyond 9 WA have been included.

Topics: Abortifacient Agents, Nonsteroidal; Abortion, Induced; Adult; Amenorrhea; Female; France; Humans; Longitudinal Studies; Mifepristone; Misoprostol; Pregnancy; Pregnancy Trimester, First; Prospective Studies; Young Adult

To evaluate the efficacy and safety of home administration of buccal misoprostol after mifepristone for medical abortion up to 70 days' gestation in a general practice in Curaçao, where induced abortion is severely restricted by law.. In a prospective study 330 women received 200 mg mifepristone and were instructed to take four tablets (800 μg) of misoprostol via the buccal route 24-36 h later, at home. One week later, follow-up took place.. The outcome could be evaluated in 307 of the 330 women. The efficacy of the mifepristone-buccal misoprostol procedure was 97.7% (300/307). In seven women vacuum aspirations for continuing pregnancy or incomplete abortion following treatment were required. Success rates at 64-70 days' gestation were the same as for gestations of less than 64 days duration. The main adverse effects were nausea and diarrhoea.. Home administration of buccal misoprostol 24-36 h after mifepristone is a safe and effective method of medical abortion up to 70 days. It could be applied in a general practice in Curaçao, where induced abortion is legally restricted.

Topics: Abortifacient Agents, Nonsteroidal; Abortifacient Agents, Steroidal; Abortion, Induced; Administration, Buccal; Adult; Ambulatory Care Facilities; Amenorrhea; Drug Therapy, Combination; Female; Follow-Up Studies; Humans; Mifepristone; Misoprostol; Netherlands Antilles; Pregnancy; Prospective Studies; Self Administration; Treatment Outcome; Young Adult

To identify possible risk factors for failure of medical abortion.. Retrospective study of data collected between 1 January 2001 and 31 December 2005, concerning 1850 women who, for medical abortion up to 49 days of amenorrhoea, had received 600 mg oral mifepristone followed 48 h later by 400 microg oral misoprostol and, if necessary, a second oral dose of 400 microg.. The method was effective in 97.1% of cases. Fifty four failures (2.9%) were recorded, including seven continuing pregnancies (0.4%). The global efficacy rate of this mifepristone-misoprostol regimen is among the best using similar treatment protocols. The proportion of failures augmented with parity.. This study suggests that parity is a major factor influencing the success of medical abortion. A greater parity of the patients was associated with a lower efficacy of treatment.

Topics: Abortifacient Agents, Steroidal; Abortion, Induced; Adolescent; Adult; Amenorrhea; Chorionic Gonadotropin; Cohort Studies; Dose-Response Relationship, Drug; Female; Humans; Middle Aged; Mifepristone; Misoprostol; Parity; Pregnancy; Retrospective Studies; Risk Factors; ROC Curve; Young Adult