A randomized controlled trial comparing two protocols for the use of misoprostol in midtrimester pregnancy termination

OBJECTIVE: Our purpose was to compare the efficacy of oral misoprostol with that of vaginal misoprostol for midtrimester termination of pregnancy. STUDY DESIGN: Women seen for midtrimester pregnancy termination were randomly assigned to receive either misoprostol orally in a dose of 200 microg every hour for 3 hours followed by 400 microg every 4 hours or vaginally in a dose of 400 microg every 4 hours. The protocol was followed for 24 hours, after which time further management was at the discretion of the attending physician. The primary outcome measure was the induction-to-delivery interval. Sample size was calculated a priori. Statistical analysis was performed with the t test for continuous variables and the chi(2) test for categorical variables. P <.05 was considered significant. RESULTS: One hundred fourteen women were randomized, with 49 receiving vaginal misoprostol and 65 receiving oral misoprostol. The two groups were comparable with respect to maternal age, parity, indication for pregnancy termination, gestational age, and maternal weight. The mean induction-to-delivery interval was significantly shorter for the vaginal group (19.6 +/- 17.5 hours vs 34.5 +/- 28.2 hours, P <.01). Length of stay was also shorter in the vaginal group (32.3 +/- 17.3 hours vs 50.9 +/- 27.9 hours, P <.01). Significantly more patients in the vaginal group were delivered within 24 hours (85.1% vs 39.5%, P <.01), and more patients in the oral group required changes in the method of induction when they were undelivered after 24 hours (38.2% vs 7%, P <.01). The only complication was an increase in febrile morbidity in the vaginal group (25% vs 6.7%, P =.046). This did not result in an increased use of antibiotics, and all the fevers resolved post partum without further complications. CONCLUSIONS: Vaginal administration of misoprostol resulted in a shorter induction-to-delivery interval. The shorter length of stay should result in improved patient care.     

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.     

Vaginal misoprostol for pre-abortion cervical priming: is there an optimal evacuation time interval?

OBJECTIVE: To determine the optimal evacuation time interval in the use of vaginal misoprostol for cervical priming before first trimester termination of pregnancy. DESIGN: Prospective double-blind randomised study. SETTING: Fertility Control Centre, National University Hospital, Singapore. METHODS: Sixty healthy nulliparous women requesting legal termination of pregnancy between 6 and 11 weeks of gestation were randomly allocated to either the 400 microg or 600 microg misoprostol group. Vacuum aspiration was performed after three hours in the 400 microg group and at the end of two hours in the women given 600 microg misoprostol. Using Hegar's dilator, degree of cervical dilatation before operation was measured. Other parameters assessed included the amount of additional dilatation required (if < Hegar 8), pre-operative and intra-operative blood loss, and associated side effects. RESULTS: For the 600 microg group, only five women (16.7%) achieved a cervical dilatation of > or = 8 mm, compared with 28 women (93.3%) in the 400 microg group. Using the 400 microg misoprostol group as a baseline, the odds ratio was 0.014 (95% CI 0.003-0.080) for 600 microg for successful pre-operative cervical dilatation of > or = 8 mm. The mean cervical dilatation for 400 and 600 microg misoprostol was 8.1 mm and 6.6 mm, respectively (P < 0.001). Despite the shorter evacuation time interval of two hours, the 600 microg dose was associated with an increase in side effects such as vaginal bleeding, abdominal pain and a fever of > 38.0 degrees C. However, other than abdominal pain, no significant differences in the frequency of these side effects were shown. CONCLUSION: Use of 400 microg misoprostol with a minimal evacuation time interval of three hours still appears the optimal dosage and evacuation time for cervical priming before first trimester termination of pregnancy.     

Evacuation interval after vaginal misoprostol for preabortion cervical priming: a randomized trial.

OBJECTIVE: To determine the optimal interval for evacuation after preabortion cervical priming with vaginal misoprostol. METHODS: One hundred eighty healthy nulliparas requesting legal termination of pregnancy between 6 and 11 weeks' gestation were assigned randomly to receive 400, 600, or 800 microg of intravaginal misoprostol. Vacuum aspiration was done after 3 hours in the 400-microg group and after 2 hours in the 600- and 800-microg groups. The degree of cervical dilatation before operation was measured with a Hegar dilator. Preoperative and intraoperative blood loss and associated side effects were also assessed. RESULTS: Eleven (18.3%) and 15 (25.0%) women in the 600-and 800-microg groups, respectively, had cervical dilatation of at least 8 mm after an interval of 2 hours; 55 (91.7%) women who received 400 microg for a 3-hour interval had similar cervical dilatation. Using 400 microg as a baseline, the odds ratio (OR) was 0.02; 95% confidence interval (CI) was 0.01, 0.06 for 600 microg and OR 0.03; 95% CI 0.01, 0.09 for 800 microg for achieving successful preabortion cervical dilatation of at least 8 mm. The mean cervical dilatation of 6.7 mm and 6.8 mm for the higher doses was also significantly less than that of 8.1 for the 400-microg dose (P<.001). The mean preoperative and intraoperative blood loss was only statistically different when the 400- and 800-microg groups were compared (P = .03). There were also significantly more side effects, namely abdominal pain and fever above 38.0 C, in the 600- and 800-microg groups (P<.001), compared with the 400-microg group. When the 600- and 800-microg groups were compared, there were still significantly more women complaining of abdominal pain (P<.001). None of the women in the study required analgesics for pain or antipyretics for fever. CONCLUSION: The minimal evacuation interval should be at least 3 hours for successful preabortion cervical priming.     

A randomized trial of oral and vaginal misoprostol to manage delivery in cases of fetal death

OBJECTIVE: To compare the effectiveness and side effects of oral and vaginal misoprostol for the termination of second and third trimester pregnancy with intrauterine fetal death. METHODS: Eighty pregnant women at 16-41 weeks' gestation with intrauterine fetal death were randomized in two groups to receive either 400 micro g of misoprostol orally every 4 hours (n = 40) or 200 micro g of misoprostol vaginally every 12 hours (n = 40) until the termination of pregnancy was completed. The adverse effects, progress, and outcomes of delivery were assessed. RESULTS: The groups were similar in age, weight, height, gestational age, parity, and modified Bishop scores before intervention. The mean induction-to-delivery time in the oral group (13.95 [standard deviation (SD) = 5.63] hours) was significantly shorter than the time in the vaginal group (18.87 [SD = 10.38] hours, P =.001). The number of deliveries within 24 hours after the initial drug administration in the oral group (92.5%) was significantly higher than the number in the vaginal group (67.5%, P <.001), and all delivered within 48 hours after the initial drug administration. However, the gastrointestinal side effects in the oral group was significantly higher than in the vaginal group (P =.005). CONCLUSION: Misoprostol (400 micro g given orally every 4 hours) was more effective than misoprostol (200 micro g given vaginally every 12 hours) for the termination of second and third trimester pregnancy with intrauterine fetal death, but with more gastrointestinal side effects.     

A randomised trial of two regimens of vaginal misoprostol to manage termination of pregnancy of up to 16 weeks

OBJECTIVE: The purpose of this study was to compare the efficacy and side-effects of two regimens of vaginal misoprostol for pregnancy termination of up to 16 weeks. METHODS: A randomised clinical trial of medical pregnancy termination of up to 16 weeks was conducted. A hundred pregnant women requesting legal termination of pregnancy were randomised into two groups to receive either 200 microg (50 women) or 400 microg (50 women)--vaginal misoprostol every six hours up to four doses. Outcome of abortion and side-effects were assessed. RESULTS: The groups were similar in maternal age, gestational age, parity and indication for pregnancy termination. There were no statistically significant differences between the two groups in abortion (P = 0.084) and mean induction to abortion time (P = 0.35). However, the side-effects in the 400 microg group were significantly higher than in the 200 microg group (P = 0.000). Conclusion: In pregnancy termination of up to 16 weeks, 200 microg vaginal misoprostol every six hours up to four doses was as effective as 400 microg, but side-effects were more common in 400 microg regimen.     

Prospective randomized clinical trial of inpatient cervical ripening with stepwise oral misoprostol vs vaginal misoprostol

OBJECTIVE: The purpose of this study was to compare the efficacy and safety of stepwise oral misoprostol vs vaginal misoprostol for cervical ripening before induction of labor. STUDY DESIGN: Two hundred and four women between 32 to 42 weeks of gestation with an unfavorable cervix (Bishop score < or = 6) and an indication for labor induction were randomized to receive oral or vaginal misoprostol every 4 hours up to 4 doses. The oral misoprostol group received 50 microg initially followed by 100 microg in each subsequent dose. The vaginal group received 25 microg in each dose. The primary outcome was the interval from first misoprostol dose to delivery. Patient satisfaction and side effects were assessed by surveys completed after delivery. RESULTS: Ninety-three (45.6%) women received oral misoprostol; 111 (54.4%) received vaginal misoprostol. There was no difference in the average interval from the first dose of misoprostol to delivery in the oral (21.1 + 7.9 hrs) and vaginal (21.5 + 11.0 hrs, P = NS) misoprostol groups. The incidence of hyperstimulation in the oral group was 2.2% vs 5.4% in the vaginal group, P = NS. Eighteen patients in the oral group (19.4%) and 36 (32.4%) in the vaginal group underwent cesarean section (P < .05). This difference was attributed to better tolerance of more doses of misoprostol by the women in the oral group. There was no difference in side effects (nausea, vomiting, diarrhea, shivering) between groups. Fourteen percent of women in the vaginal group versus 7.5% in the oral group were dissatisfied with the use of misoprostol (P = NS). CONCLUSION: Stepwise oral misoprostol (50 microg followed by 100 microg) appears to be as effective as vaginal misoprostol (25 microg) for cervical ripening with a low incidence of hyperstimulation, no increase in side effects, a high rate of patient satisfaction, and is associated with a lower cesarean section rate.     

Nonsurgical mid-trimester termination of pregnancy: a review of 500 consecutive cases.

OBJECTIVE: To assess the effectiveness of a regimen comprising mifepristone followed by a combination of the vaginal and oral administration of misoprostol for mid-trimester medical termination of pregnancy. DESIGN: Retrospective analysis of prospectively collected data in women undergoing mid-trimester medical termination of pregnancy. SETTING: Aberdeen Royal Infirmary, Scotland. SAMPLE: A consecutive series of 500 women with pregnancies of 13-21 weeks of amenorrhea undergoing legally induced abortion in one Scottish NHS hospital. METHODS: Each woman received a single oral dose of mifepristone 200 mg and 36-48 h later vaginal misoprostol 800 microg. Three hours following the first dose of misoprostol, 400 microg doses were administered orally at three hourly intervals, to a maximum of four doses. Success was defined as abortion occurring with five doses of prostaglandin, or within 15 h of administration of the first dose of prostaglandin. RESULTS: Ninety-seven percent aborted successfully. The median dose of misoprostol required was 1200 microg and the median induction-to-abortion interval after first prostaglandin administration was 6.5 h. The median number of doses of misoprostol required to induce abortion, and the induction-to-abortion interval, was statistically significantly higher among women at gestations 17-21 weeks than among those at 13-16 weeks (P = 0.0001). A total of 9.4% required surgical evacuation of the uterus under general anaesthesia and 66.4% of the women were managed as day cases. CONCLUSIONS: The combination of oral mifepristone 200 mg followed by vaginally and orally administered misoprostol provides a noninvasive and effective regimen for second trimester termination of pregnancy.     

Efficacy of two regimens of misoprostol for early second-trimester pregnancy termination

OBJECTIVE: To compare the efficacy of a combined regimen of misoprostol with vaginal misoprostol for early 2nd-trimester pregnancy termination. METHODS: This is a prospective study that includes 79 pregnant women who requested legal termination of 2nd-trimester pregnancy between 13 and 22 weeks. Two regimens of misoprostol were used. Group 1: 400 microg of oral plus 400 microg vaginal misoprostol every 8 h (combined regimen) and group 2: 400 microg of vaginal misoprostol every 3 h up to a maximum of five doses (vaginal regimen). RESULTS: The induction-to-abortion interval was significantly longer in group 1 (25.5 +/- 24.45 h) than in group 2 (15 +/- 7.14 h) (p = 0.016). The abortion rate within 24 h in group 1 was of 56.8 vs. 85.7% in group 2 (p = 0.006). The hazard rate for vaginal delivery within 24 h was found to be 2.277-fold greater in the group with the combined therapy once controlled for plausible confounders. CONCLUSIONS: Our study suggests that oral misoprostol combined with vaginal misoprostol does not reduce the induction-to-abortion interval compared to an exclusively vaginal route when used for early 2nd-trimester pregnancy termination.     

Vaginal misoprostol versus concentrated oxytocin and vaginal PGE2 for second-trimester labor induction

OBJECTIVE: To compare the efficacy, side effects, and complications of high-dose vaginal misoprostol with concentrated intravenous oxytocin plus low-dose vaginal prostaglandin (PGE(2)) for second-trimester labor induction. METHODS: One hundred twenty-six consenting women with maternal or fetal indications for pregnancy termination and no prior cesarean delivery were randomly assigned to receive either vaginal misoprostol 600 microg 1x, 400 microg every 4 hours 5x (misoprostol group, n = 60) or escalating-dose concentrated oxytocin infusions (277-1,667 mU/min) plus vaginal PGE(2) 10 mg every 6 hours 4x (oxytocin group, n = 66). Both groups received concurrent extra-amniotic saline infusion for cervical ripening. Women who failed their assigned regimen received 20 mg of PGE(2) suppositories every 4 hours until delivery. Analysis was by intent to treat. RESULTS: Demographic characteristics were similar between study groups. Median induction-to-delivery interval was significantly shorter in the misoprostol group (12 hours) than in the oxytocin group (17 hours; P <.001). There was a higher induction success rate at 24 hours in the misoprostol group (95%) than in the oxytocin group (85%; P =.06), although this difference did not reach statistical significance. The incidence of live birth (25% versus 17%), chorioamnionitis (5% versus 2%), and postpartum hemorrhage greater than 500 mL (3% versus 3%) were similar between the misoprostol and oxytocin groups, respectively. Diarrhea (2% versus 11%; P =.04), nausea/emesis (25% versus 42%; P =.04), and retained placenta requiring curettage (2% versus 15%; P =.008) were significantly less common in the misoprostol group when compared with the oxytocin group, respectively. Isolated intrapartum fever, however, was more frequent in the misoprostol group (67%) than in the oxytocin group (21%; P <.001). CONCLUSION: Compared with concentrated oxytocin plus low-dose vaginal PGE(2), high-dose vaginal misoprostol is associated with significantly shorter induction-to-delivery intervals, fewer side effects, a lower incidence of retained placenta, and comparable incidence of live birth.     

Misoprostol and first trimester pregnancy termination

OBJECTIVE: To investigate the efficacy of vaginal administration of 800 microg misoprostol as a single dose without performing post expulsion systematic curettage in first trimester pregnancy termination. METHOD: 113 women, aged 16-44, who requested first trimester pregnancy termination, received 800 microg of vaginal misoprostol. All examined women were divided into two groups depending on gestation age. The first group included of 67 women with up to nine weeks and the second of 46 with up to 12 weeks of pregnancy. RESULTS: Abortion occurred within 24 hours and was completed in 74.3% of the cases. The mean induction-abortion interval was 5.9 +/- 1.7 hours (median 5.5 hours). Side-effects were experienced by 24 women (21.2%). There was no significant difference between groups in the success rate, induction-abortion interval, number of previous deliveries and side-effects. CONCLUSION: Misoprostol is an effective agent for first trimester medical termination.     

A randomised trial of oral versus vaginal administration of misoprostol for the purpose of mid-trimester termination of pregnancy

A prospective randomised controlled trial was undertaken to compare the efficacy of two routes of administration, oral versus vaginal, of the prostaglandin E1 analogue misoprostol (Cytotec) to effect termination of pregnancy in the mid-trimester. Fifty-five women were recruited into the trial; 26 to receive all doses orally and 29 via the vaginal route. The dosing regimen was 400 microg as the initial dose followed by a second dose of 200 microg two hours later and then four-hourly 200 microg doses until delivery or 32 hours from commencement of treatment. If delivery had not been effected by the last dose of misoprostol, a Syntocinon infusion was started synchronously Misoprostol administered vaginally was significantly more effective than when administered orally as judged by induction-to-delivery interval and also the need or otherwise to augment therapy with a Syntocinon infusion. The average induction-to-delivery interval was 17.5 hours in the vaginal group compared to 33 hours in the oral group (p = 0.0003). The percentages of women who delivered at 24 and 48 hours were 93% and 100% in the vaginal administration group and 19% and 70% in the oral administration group (p < 0.05). No significant differences in complication rates or side effects were noted between the two groups     

Randomized comparison of dry tablet insertion versus gel form of vaginal misoprostol for second trimester pregnancy termination

AIM: To compare the effectiveness of vaginal misoprostol between dry tablet insertion and gel form for second trimester pregnancy termination. METHODS: A non-blinded block randomized controlled trial was conducted on 148 pregnant women with live fetuses in the second trimester undergoing pregnancy termination. They were randomly allocated to receive vaginal misoprostol (400 microg) either dry tablet insertion (n=72) or gel form (n=76). The same dose was then repeated every 3 h if adequate uterine contraction was not achieved until 48 h after the initiation of misoprostol. If abortion did not occur within this period, the treatment was considered a failure and other technique of termination was then given based on the decision of the attending physicians and the cervical status. RESULTS: The mean induction-abortion interval in group 1 (20.9+/-12.3 h) was not significantly different from that in group 2 (17.7+/-10.2 h). The mean total dose of misoprostol was also not significantly different between the two groups (group 1, 1556.9 microg; group 2, 1350.9 microg), but the adverse effects of misoprostol (chill and diarrhoea) were more common in the gel group. CONCLUSION: Tablet insertion or gel form of vaginal misoprostol have similar effectiveness but the gel form was associated with more common adverse effects.     

Sublingual versus vaginal misoprostol for cervical ripening PRIOR TO manual vacuum aspiration under local anaesthesia: a randomized study.

OBJECTIVE: To compare the effectiveness of sublingual and vaginal misoprostol application for cervical ripening prior to manual vacuum aspiration (MVA) under local anaesthesia for voluntary termination of pregnancy between 7 and 10 weeks of gestation. MATERIALS AND METHODS: Prospective randomized study in which 72 women were randomly assigned to administration of either 400 microg vaginal misoprostol 3 hours prior to or 200 microg sublingual misoprostol 2 hours prior to the surgical procedure. We took the preoperative cervical dilatation that was achieved as the main outcome measure. The duration of the procedure, intra-operative blood loss, pain perception before and during the operation, patients' satisfaction, side effects and duration of post-operative bleeding were secondary outcome measures. RESULTS: A similar pre-operative cervical dilatation was achieved in the sublingual and the vaginal groups (6.9 +/- 1.6 mm and 6.6 +/- 1.1 mm, respectively; p = 0.3). The duration of the operation, intra-operative blood loss, and patients' satisfaction did not differ between the two groups. Pain scores were significantly higher in the sublingual group than in the vaginal group, both after administration of misoprostol (p = 0.02) and during the procedure (p = 0.02). Nausea and vaginal spotting were significantly more frequent (p = 0.01 and p = 0.003, respectively), but post-operative bleeding significantly shorter (p = 0.003) in the sublingual group. CONCLUSION: Administration of 200 microg sublingual misoprostol 2 hours before suction curettage under local anaesthesia was as effective as 400 microg vaginal misoprostol 3 hours before that procedure with regard to achieving cervical dilatation. It resulted in higher pre-operative and intra-operative pain scores without changing patients' satisfaction.     

Randomized controlled trial of misoprostol for second-trimester pregnancy termination associated with fetal malformation

OBJECTIVE: Our purpose was to compare the effectiveness, women's views of the termination procedure, and success of umbilical cord culture for vaginal and oral misoprostol versus intra-amniotic prostaglandin PGF(2alpha) for second-trimester pregnancy termination (STPT). STUDY DESIGN: We randomized 217 women, 15 to 24 weeks' gestation, into 3 groups. Oral (OM) and vaginal (VM) misoprostol groups received 400 microg of misoprostol every 4 hours for 24 hours. The intra-amniotic PGF(2alpha) (IAPG) group received 40 mg of PGF(2alpha) followed by oxytocin infusion. Women completed self-administered questionnaires 3 weeks after the termination procedure. Umbilical cord samples were collected at delivery for karyotype analysis. The primary outcome was the time from start of the procedure to placental delivery. Secondary outcomes were maternal complications, women's acceptance of the termination procedure, and success rates of umbilical cord culture. RESULTS: The time was longer for the OM group (30.5+/-14.4 hours) compared with the VM group (18.3+/-8.2 hours) and the IAPG group (21.1+/-10.2 hours), P<.001 for both comparisons. Women in the VM group reported being more willing to repeat the termination method in the future and reported fewer side effects than those in the other groups, P<.001. Failure rates for umbilical cord cultures were 9.6%, 17.0%, and 45.6% for the VM, OM, and IAPG groups, respectively. CONCLUSION: Oral misoprostol is less effective than intra-amniotic PGF(2alpha) or vaginal misoprostol for STPT. Women report vaginal misoprostol more acceptable than other methods. Umbilical cord culture failure rate is highest in the IAPG group.     

The optimization of intravaginal misoprostol dosing schedules in second-trimester pregnancy termination

OBJECTIVE: The purpose of this study was to compare the clinical efficacy and side effects of 3 doses of intravaginal misoprostol for second-trimester pregnancy termination. STUDY DESIGN: This was a prospective randomized, double-blind controlled clinical trial of 150 women who underwent pregnancy termination between 14 and 30 weeks of gestation. Three intravaginal misoprostol regimens were compared: 200 microg misoprostol at 6-hour intervals (group 1), 400 microg misoprostol at 6-hour intervals (group 2), and a loading dose of 600 microg misoprostol followed by 200 microg at 6-hour intervals (group 3). RESULTS: There was a significant difference in the median time to achieve delivery among the 3 groups: group 1 (18.2 hours [IQ, 13.3-32.5 hours]) vs group 2 (15.1 hours [IQ, 10.9-23.7 hours]) vs group 3 (13.2 hours [IQ, 11.2-21.7 hours]; P =.035). Fifty-nine percent of the women in group 1, 76% of the women in group 2, and 80% of the women in group 3 delivered within 24 hours (P =.013). There were 7.8% of the women in group 1, 0% of the women in group 2, and 2% of the women in group 3 who were undelivered at 48 hours (P =.02). There was an increase in the incidence of fever in the first 12 hours (P =.038) and in the incidence of vomiting within 3 hours of the initial dose (P =.048) in group 3 compared with the other groups. CONCLUSION: Intravaginal misoprostol 400 microg at 6-hour intervals appears to be the preferred regimen for second-trimester pregnancy termination, with a shorter commencement to delivery interval than the 200 microg regimen and fewer maternal side-effects than the 600 microg loading dose regimen.     

A randomised controlled trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion up to 13 weeks of gestation

OBJECTIVE: To assess women's acceptability, the efficacy and side effects of sublingual versus vaginal administration of misoprostol in combination with mifepristone for medical abortion up to 13 weeks of gestation. DESIGN: Randomised controlled trial. SETTING: Aberdeen Royal Infirmary. POPULATION: Women undergoing medical abortion under the terms of the 1967 Abortion Act. METHODS: Mifepristone (200 mg) was given orally followed 36-48 hours later by misoprostol administration (sublingual: 600 microg; vaginal: 800 microg). A second dose of misoprostol 400 microg was given 3 hours later (sublingually or vaginally). Women between 9 and 13 weeks of gestation received a further (third) dose of misoprostol 400 microg (sublingually or vaginally), 3 hours later if abortion had not occurred. MAIN OUTCOME MEASURES: Women's acceptability, efficacy of the regimen and side effects experienced. RESULTS: A total of 340 women were recruited (171 sublingual and 169 vaginal). A total of 70% of women in the sublingual group expressed satisfaction with the route of misoprostol administration; 18% answered 'Don't know' while 12% were dissatisfied, compared with 68%, 28% and 4%, respectively, in the vaginal group (P= 0.02). There was no significant difference in the need for surgical evacuation for women in the sublingual (3/158, 1.9%) and vaginal groups (4/156, 2.6%) (P= 0.70). Women receiving misoprostol sublingually were more likely to experience diarrhoea (P < 0.01), shivering (P < 0.01) and unpleasant mouth taste (P < 0.01). CONCLUSIONS: Sublingual administration of misoprostol is an effective alternative to vaginal administration for medical abortion up to 13 weeks of gestation. The prevalence of prostaglandin-related side effects, however, was higher with this route of administration.     

Intravaginal misoprostol 600 μg and 800 μg for the treatment of early pregnancy failure

Objective: To compare the respective effectiveness and safety of 600 μg and 800 μg of intravaginal misoprostol for complete abortion in cases of early pregnancy failure (occurring in the first 12 weeks). Method: A total of 114 women with a diagnosis of early pregnancy failure made by transvaginal ultrasonography at Rajavithi Hospital between November 25, 2002 and July 31, 2003, were assigned randomly to 2 groups of equal size. In one group the women received 600 μg of misoprostol and in the other 800 μg of misoprostol intravaginally. Results: The rate of complete abortion within 24 h was significantly higher in the group that received 800 μg of misoprostol (68.4%) than in the other group (45.6%) (P < 0.05). There were no significant differences between the 2 groups regarding time interval between misoprostol insertion and complete abortion or side effects. Conclusion: Intravaginal misoprostol 800 μg is significantly more effective than vaginal misoprostol 600 μg for the termination of an early pregnancy failure, with no significant differences in side effects.     

Mifepristone 100 mg in abortion regimens

OBJECTIVE: To examine the clinical efficacy of mifepristone 100 mg followed 2 days later by misoprostol 400 microg orally or 800 microg vaginally in women at up to 49 days' gestation. METHODS: Eighty participants received mifepristone 100 mg and then were randomized to misoprostol, administered 48 hours later, at a dose of 400 microg orally (group 1) or 800 microg vaginally (group 2). Women returned for follow-up evaluations 24 +/- 1 hour after using the misoprostol and then 2-3 weeks later. If abortion still had not occurred and the pregnancy was nonviable, the subject returned again after an additional 3 weeks. RESULTS: Twenty-four hours after receiving misoprostol, 34 (85%; 95% confidence interval [CI] 71%, 94%) of the 40 women in group 1 and 38 (95%; 95% CI 85%, 99%) of the 40 women in group 2 had complete abortions. Overall, complete abortion without surgical intervention occurred in 34 women in group 1 (85%; 95% CI 71%, 94%) and 40 women in group 2 (100%; 95% CI 91%, 100%; P =.03). Four women in group 1 required suction aspiration for continuing pregnancy at the second follow-up, compared with none in group 2 (P =.12). Side effects occurred with similar frequency in both treatment groups. CONCLUSION: Low-dose mifepristone (100 mg) combined with vaginal misoprostol 800 microg may be an effective alternative to regimens using 200 or 600 mg of mifepristone with misoprostol.     

米非司酮配伍米索前列醇终止10～16周妊娠的临床多中心随机比 …

目的 探讨米非司酮合并米索前列醇（米索）终止１０－１６周妊娠最佳剂量及最佳给药途径。方法 将来自上海２４所医院的２００７例孕１０－１６周要求药物终止妊娠的妇女,随机分成４种不同的治疗组。组Ｉ,５１１例,米非司酮７５ｍｇ每天１次,连服２天（总量１５０ｍｇ）第３天晨口服米索０．６ｍｇ,每３－４小时重复１次,最多３组,组ＩＩ：４９１例,非米司酮１００ｍｇ每天１次,连服２天（总量２００ｍｇ）米索用法同组Ｉ