A randomized comparison of mifepristone and self-administered oral or vaginal misoprostol for early abortion

In France, mifepristone in association with orally administered misoprostol is widely used for the early termination of pregnancy (up to 49 days' gestation). In other centers, mifepristone in association with vaginally administered misoprostol has also been used. The aim of the present study was to compare the efficacy and tolerance of mifepristone in association with misoprostol administered orally or vaginally for the termination of pregnancy of up to 49 days' gestation.

A total of 237 women were enrolled in the study. All women received 600 mg mifepristone administered orally and 400 μg misoprostol administered either orally (n = 119) or vaginally (n = 118). A second dose of 400 μg misoprostol was administered if women had not expelled the pregnancy within 3 h. Women were randomized into treatment groups according to the day of their admission.

The overall success rate was 98.7% and there was no significant difference in efficacy between the two groups. There was one treatment failure in the group in which misoprostol was administered orally. Of those women who aborted within 3 h of administration of the first dose of misoprostol, the route of administration of misoprostol did not influence the time to abortion. Of the women who received a second dose of misoprostol, the time to abortion was shorter in those who received misoprostol orally (52 min versus 77 min).

Tolerance was assessed by visual analog scales and was similar for both groups. In both groups, women preferred the oral route of administration.     

Preference and acceptability of oral versus vaginal administration of misoprostol in medical abortion with mifepristone

OBJECTIVES: To compare the experience of pain, need of analgesic interventions, preference and acceptability in medical abortion up to 49 days of amenorrhea with mifepristone and orally versus vaginally administered misoprostol. STUDY DESIGN: Ninety-seven women were randomised to oral misoprostol, n=48, or vaginal misoprostol, n=49. On day 1 of the study, both the groups received 600 mg of mifepristone. On day 3 of the study, one group received 0.4 mg of misoprostol orally and the other group received 0.8 mg of misoprostol vaginally. RESULTS: Even though oral administration of misoprostol seemed to be associated with a higher rate of gastrointestinal side effects, women in both the groups showed a clear preference towards the oral route of administration. The willingness to administer the misoprostol at home was also higher among the women in the oral group, which may in part depend on a more positive/less negative experience of the abortion. CONCLUSION: A majority of women prefer oral administration of misoprostol in early medical abortion.     

25 mg or 50 mg of oral methotrexate followed by vaginal misoprostol 7 days after for early abortion: a randomized trial

BACKGROUND: Several combinations of oral or intravenous methotrexate plus vaginal misoprostol have been used for early abortion with success rates varying widely. So far, any study has evaluated the efficacy and safety of lower doses of oral methotrexate followed by vaginal misoprostol for early abortion. OBJECTIVES: To evaluate the efficacy and safety of methotrexate 25 or 50 mg orally and 800 micrograms of misoprostol vaginally 7 days after the methotrexate for abortion at 相似文献   

A comparison of oral and vaginal misoprostol for induction of labor

OBJECTIVE: The aim of the study is to compare the efficacy and safety of oral (100 microg) and vaginal (50 microg) misoprostol for labor induction. STUDY DESIGN: Ninety-nine patients with indications for labor induction randomly received 100 microg oral misoprostol every 4 h or 50 microg vaginal misoprostol every 4 h, using maximum six doses. Mean induction to delivery interval, mode of delivery, rates of tachysystole, hypertonus and hyperstimulation syndrome, oxytocin use, number of doses used, failed induction rate and neonatal outcomes were compared for the two groups. RESULTS: Mean dose of misoprostol used for oral and vaginal misoprostol groups were 2.17+/-1.35 and 1.91+/-0.94, respectively (p=0.65). There were two failed inductions in the oral (4%) and one failed induction (2.5%) in the vaginal group after a total of six doses of misoprostol (p=0.58). There was no significant difference for the mean induction to delivery interval, to the beginning of active phase interval, active phase duration, second stage duration and the number of women who received oxytocin for induction or augmentation between the two groups (p>0.05). There were also no significant differences for intrapartum complications and neonatal outcomes between the oral and vaginal misoprostol groups (p>0.05). CONCLUSION: Our findings indicate that, in a closely supervised hospital setting with adequate monitoring, 100 microg oral misoprostol has the potential to induce labor as safely and effectively as its 50 microg vaginal analogue. As oral use of the drug is easier for both the patient and the doctor, oral misoprostol will probably be more preferable than the vaginal route.     

A randomized controlled comparison of sublingual and vaginal administration of misoprostol for cervical priming before first-trimester surgical abortion

OBJECTIVE: The purpose of this study was to compare the effectiveness of the sublingual and vaginal administration of misoprostol for cervical priming before surgical termination of pregnancy. STUDY DESIGN: In a randomized controlled trial, 74 primigravid women who were undergoing surgical abortion were assigned randomly to receive misoprostol (400 microg) sublingually or vaginally. RESULTS: There was no statistically significant difference in the cumulative force that was required to dilate the cervix to 9 mm, for baseline cervical dilatation, for priming to abortion interval, for operating time, or for intraoperative blood loss between the two groups. Women in the sublingual group had more nausea (P=.008), vomiting (P=.01), diarrhea (P=.01), and unpleasant mouth taste (P=.0001) compared with the women in the vaginal group. In the sublingual group, 65% of women were satisfied with the route of misoprostol administration compared with 78% in the vaginal group (P=.11). Most of the staff members (84%) said that they would recommend the sublingual administration of misoprostol (P=.0001). CONCLUSION: The sublingual administration of misoprostol is an effective alternative to vaginal administration for cervical priming before surgical abortion; despite a higher incidence of side effects, there was high patient and staff acceptability.     

Regimens of misoprostol with mifepristone for early medical abortion: a randomised trial

OBJECTIVE: To compare the efficacy, adverse effects and acceptability of the three most common misoprostol regimens used with mifepristone for medical abortion. DESIGN: Randomised nonblinded trial. SETTING: Three clinics associated with major research universities in Canada; two in major urban areas and one in a periurban area. POPULATION: Women of reproductive age. METHODS: Consenting women presenting for abortion services with gestations less than 56 days and who met inclusion criteria were given 200 mg mifepristone orally and then randomised into three misoprostol study groups: (group I) 400 micrograms of oral misoprostol, (group II) 600 micrograms of oral misoprostol, and (group III) 800 micrograms of vaginal misoprostol. Misoprostol was self-administered at home 24-48 hours following mifepristone, and participants were instructed to take a second similar misoprostol dose at 24 hours after the initial dose if bleeding was less than a normal menstrual period. MAIN OUTCOME MEASURES: Successful abortion without surgery was 94.1%, with no significant differences across the three study groups (94.7% in group I, 93.4% in group II, and 94.3% in group III; P= 0.975). RESULTS: Efficacy and adverse effects did not differ significantly across the three study groups. Pain increased significantly across the study and the gestational age groups and was associated with lower acceptability. CONCLUSIONS: There appears to be a range of safe and effective options for early medical abortion with mifepristone including a choice between oral and vaginal administration of misoprostol.     

A comparison of oral misoprostol with vaginal misoprostol administration in second-trimester pregnancy termination for fetal abnormality

OBJECTIVE: To compare the clinical efficacy and side effects of oral misoprostol with vaginal misoprostol for second-trimester pregnancy termination. METHODS: A randomized clinical trial of medical pregnancy termination between 14 and 26 weeks' gestation was conducted. Three misoprostol regimens were compared: 400 microg vaginally at 6-hour intervals (group 1), 400 microg orally at 3-hour intervals (group 2), and a loading dose of 600 microg vaginally followed by 200 microg orally at 3-hour intervals (group 3). A sample size of 225 women was required for equivalence of the three regimens, with an interim safety analysis planned at 80 women. RESULTS: A significant difference between the groups was evident at the interim safety analysis and the study ceased. The subset of 84 women recruited before the study closure is described. There was a significant difference in the median time to achieve delivery among the three groups: group 1, 14.5 hours (95% confidence interval 12.0, 16.9), versus group 2, 25.5 hours (13.5, 23.8), versus group 3, 16.4 hours (interquartile range 14.2-37.3) (P =.042). Within 24 hours of commencement 85.7% of women in group 1, 44.8% in group 2, and 74.1% in group 3 delivered (P =.003). At 48 hours 0% in group 1, 20.7% in group 2, and 3.7% in group 3 were undelivered (P =.011). There was no difference in women's perceptions of the termination process. CONCLUSION: In second-trimester pregnancy termination, a vaginal misoprostol regimen of 400 microg every 6 hours was 1.9 times more likely to result in delivery within 24 hours from commencement than an oral regimen of 400 microg every 3 hours.     

Oral versus vaginal misoprostol for cervical priming in first-trimester abortion: a randomized trial.

The objective of this study was to compare the oral and vaginal administration of misoprostol for cervical priming before surgical abortion up to 63 days' gestation. A total of 900 pregnant women, with ages ranging from 18 to 42 years, who asked for pregnancy termination, were included in this study. Women were randomly allocated to one of the following groups: oral administration of 400 microg misoprostol, 8 h before aspiration; and vaginal self-administration of 400 microg misoprostol, 4 h before aspiration. During admission, all subjects were checked on a 15-min basis. The preoperative cervical dilatation achieved was the main outcome assessed. The cervix was dilated (Hegar > or = 8) in 348 (78%) subjects from the oral treatment group and in 391 (87%) women from the vaginal treatment group; this difference was statistically significant (p = 0.0004). The mean dilatation achieved in the oral treatment group was 8.1 mm (SD 1.6 mm) and it was 8.5 mm (SD 1.5 mm) in the vaginal treatment group; this difference was statistically significant (p = 0.0001). The frequencies of side-effects such as nausea, vomiting, diarrhea and chills reported by women from the vaginal misoprostol group were 10, 8, 18 and 4 times lower, respectively, than those reported by subjects from the oral misoprostol group. In conclusion, vaginal self-administration of misoprostol was the best administration route, as it obtained the same or greater priming effectiveness of the cervix in half the time with a much lower frequency of side-effects.     

Predictors of successful labor induction with oral or vaginal misoprostol.

OBJECTIVE: To identify independent predictors of successful labor induction with oral or vaginal misoprostol. METHODS: Women enrolled in four previous randomized trials involving oral or vaginal misoprostol for cervical ripening and labor induction were included in the present cohort study, with dosing of 25-50 microg every 4 to 6 h vaginally (n = 574) or 50 microg every 4 h orally (n = 207). Multiple logistic regression was performed to identify factors independently associated with successful labor induction -- defined as vaginal delivery within 12 h, vaginal delivery within 24 h and spontaneous vaginal delivery. Predictors of Cesarean birth and the need for only one dose of misoprostol were also identified. Variables included in the models were maternal age, weight, height, parity, gravidity, membrane status, route of misoprostol, gestational age, birth weight, and Bishop score and its individual components. RESULTS: Maternal age, height, weight, parity, birth weight, dilatation, effacement and cervical station were associated with vaginal delivery within 24 h of induction. Maternal age, height, weight, nulliparity, birth weight and route of misoprostol were associated with Cesarean birth, with oral misoprostol being associated with a lower rate of Cesarean birth. The need for only one dose of misoprostol was predicted by maternal height, weight, parity, gestational age, Bishop score and route of misoprostol. CONCLUSION: Characteristics of the woman (height, weight, parity), the fetus (birth weight) and some of the individual components of the Bishop score, were associated with successful labor induction, with oral misoprostol being associated with a lower rate of Cesarean birth.