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.     

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.     

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.     

Mifepristone versus vaginally administered misoprostol for cervical priming before first-trimester termination of pregnancy: a randomized, controlled study

OBJECTIVE: This study was undertaken to compare the effectiveness of mifepristone orally administered at 24 or 48 hours before first-trimester vacuum aspiration abortion with that of vaginally administered misoprostol as a cervical priming agent. STUDY DESIGN: In a randomized comparative trial 90 women who requested surgical termination of pregnancy were randomly assigned to receive 200 mg mifepristone orally 24 or 48 hours before the operation or 800 microg misoprostol vaginally 2 to 4 hours before the operation. The main outcome measures were baseline cervical dilatation, cumulative force required to dilate the cervix to 9 mm, and intraoperative blood loss. RESULTS: The baseline cervical dilatation was significantly greater among women who received mifepristone 48 hours before the operation (P =.02). This group also required the least mechanical force to dilate the cervix (P =.06). There were no significant differences among the 3 groups in the intraoperative blood loss, in the operating time, or in patient acceptability. Side effects such as hot flushes and headaches were significantly higher among women who received mifepristone 24 or 48 hours before the operation than among those who received misoprostol (P =.01 and P =. 002, respectively). CONCLUSION: Mifepristone is an effective cervical priming agent when orally administered 48 hours before vacuum aspiration for termination of first-trimester pregnancy. Because of its cost and availability in comparison with misoprostol, however, selective use may have to be considered.     

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较性研究

目的探索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次;组Ⅱ：４９１例,米非司酮１００ｍｇ每天１次,连服２天（总量２００ｍｇ）,米索用法同组Ⅰ;组Ⅲ：５１９例,米非司酮用法同组Ⅰ,第３天晨阴道内放置米索０．６ｍｇ,每１２小时重复１次,最多３次;组Ⅳ：４８６例,米非司酮用法同组Ⅱ,米索用法同组Ⅲ。结果４组２４小时内的流产成功率分别为８８．６％、８９．４％、９０．９％和９４．０％。组Ⅳ的成功率明显高于组Ⅰ和组Ⅱ。２４小时内流产成功者米索的用量,阴道给药者比口服给药者明显减少（Ｐ＜０．００１）,胃肠道副反应发生率也明显降低（Ｐ＜０．０５）。结论口服米非司酮２００ｍｇ合并阴道放置米索,是较好的药物终止１０～１６周妊娠的方法,可作为一种常规方法推荐在临床应用。     

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     

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.     

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 misoprosto1800 pg. Three hours following the first dose of misoprostol, 400 yg 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 yg and the median induction-toabortion interval after first prostaglandin administration was 6.5 h. The median number of doses of misoprostol required to induce abortion, and the induction-toabortion 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.     

Early medical abortion: a new regimen up to 49 days' gestation

AIM: To evaluate a new regimen of mifepristone and misoprostol in early medical abortion up to 49 days of amenorrhoea. METHODS: One hundred healthy women requesting pregnancy termination up to 49 days gestation received 200 mg mifepristone followed by 800 microg misoprostol orally 24 h later. Statistical analysis was carried out by unpaired t-test. RESULTS: Ninety-six percent of patients aborted completely 4.3 h after they were given misoprostol. No significant side-effects were noted. The duration of bleeding correlated with gestational age (P-value 0.009). CONCLUSION: This new regimen of mifepristone-misoprostol is effective in terminating early pregnancy, with shorter induction to abortion interval and greater acceptability.     

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.     

A randomized comparison of two regimens of misoprostol for second-trimester pregnancy termination

OBJECTIVE: The purpose of this study was to compare the efficacy and side effects of two different misoprostol regimens for second-trimester pregnancy termination. STUDY DESIGN: We performed a randomized clinical trial in patients who were at 14 to 23 weeks of gestation and who were admitted for medical termination of pregnancy. All patients received 800 microg of vaginal misoprostol and were assigned randomly to 400 microg of oral misoprostol or 400 microg of vaginal misoprostol every 8 hours. Efficacy and side effects were compared. The mean induction time of the study group was compared with that of an historic control group that had received 400 microg vaginally every 12 hours. RESULTS: Forty-three women were assigned randomly, 22 women to vaginal misoprostol and 21 women to oral misoprostol. Induction time and hospital stay were slightly shorter for the oral group; however, the differences were not significant. Side effects were similar for both groups. CONCLUSION: After an initial 800 microg dose of vaginal misoprostol, a regimen of 400 microg of oral misoprostol every 8 hours is as effective as the same dose of vaginal misoprostol with no additional side effects, which provides a convenient alternative for midtrimester pregnancy termination.     

Mifepristone and misoprostol and methotrexate/misoprostol in clinical practice for abortion

OBJECTIVE: The purpose of this study was to evaluate the efficacy, side-effect profile, and follow-up rates in women who obtain a medical abortion in a nonresearch setting. STUDY DESIGN: From December 1, 2000, to June 30, 2001, we prospectively followed 218 women who had been evaluated in our private office for medical abortion. Women received either mifepristone 200 mg orally followed 1 to 2 days later by self-administered misoprostol 800 microg vaginally or methotrexate 50 mg/m(2) intramuscularly followed 3 to 7 days later by self-administered misoprostol 800 microg vaginally. RESULTS: Of the 174 women who had a medical abortion, 148 women (85%) chose mifepristone/misoprostol, and 26 women (15%) chose methotrexate/misoprostol. In women up to 49 days of gestation, complete abortion occurred by the first follow-up visit in 82 of 86 women (95%; 95% CI, 89-99) and in 21 of 25 women (84%; 95% CI, 64-95) women, respectively. In women who used mifepristone/misoprostol from 50 to 63 days of gestation, complete abortions occurred in 56 of 59 women (95%; 95% CI, 86-99) women. Four women (2%; 95% CI, 1-6) were lost to follow-up. CONCLUSION: Medical abortion with mifepristone/misoprostol and with methotrexate/misoprostol can be provided in a nonresearch setting with efficacy similar to that reported in the medical literature for research protocols.     

Early pregnancy termination with intravaginally administered sodium chloride solution-moistened misoprostol tablets: historical comparison with mifepristone and oral misoprostol

OBJECTIVE: The purpose of this study was to compare the abortifacient effect of intravaginally administered moistened misoprostol tablets with that of the combination regimen of mifepristone and oral misoprostol. STUDY DESIGN: One hundred women at 相似文献   

Mifepristone followed in 24 hours to 48 hours by misoprostol for late first-trimester abortion

OBJECTIVE: To investigate the efficacy of mifepristone and misoprostol for the termination of pregnancies in the late first trimester. METHODS: This was a prospective study of 321 women seeking termination of pregnancy with gestations from 64 days to 84 days (+/-3 days) by vaginal ultrasonography. Women were enrolled at three sites: University of Rochester Reproductive Health Program in Rochester, New York; Hung Vuong Hospital in Ho Chi Minh City, Vietnam; and K.E.M. Hospital in Pune, India. Eligible women received 800 mcg of misoprostol vaginally between 24 hours and 48 hours after administration of 200 mg mifepristone. Two additional doses of 400 mcg of misoprostol were administered either orally or vaginally as needed every 3 hours for a maximum of two additional doses (total 1,600 mcg). The primary study outcome measure was complete abortion without surgical intervention. RESULTS: Eighty-nine percent of women who completed the study successfully terminated their pregnancies. Most women were either satisfied (64.8%) or very satisfied (28.6%) with their experience. Ninety-four percent of women reported that they would recommend the procedure to a friend. Most women (90.4%) also agreed they would request a medical abortion if they required another abortion at this gestational age. CONCLUSION: Medical abortion is acceptable and effective in the late first trimester and offers women an acceptable alternative to surgical abortion. LEVEL OF EVIDENCE: II.     

Randomized, double-blind, controlled trial of mifepristone in capsule versus tablet form followed by misoprostol for early medical abortion

OBJECTIVE: To compare the efficacy and side-effects of mifepristone 75 mg in capsule form versus 150 mg in tablet form followed by misoprostol for medical termination of early pregnancy. STUDY DESIGN: In a prospective randomized, double-blind, placebo-controlled trial, a total of 480 women who were 49 days or less pregnant were randomized by means of a random number table to receive either two tablets in the morning and one tablet 12 h later for 2 days (group A) or three capsules orally twice daily for 2 days, the first dose being double all subsequent doses (group B). After a further 48 h, 600 microg misoprostol was given orally. Successful abortion was defined as complete abortion with no need for surgical aspiration. RESULTS: There were no significant differences between the two study groups in the rates of complete abortion (95.4% in group A versus 96.3% in group B), incomplete abortion (3.8% in group A, 3.3% in group B) and continued pregnancy (0.8% in group A, 0.4% in group B). No significant difference in the duration and amount of vaginal bleeding was observed. The incidence of side-effects, such as vomiting, nausea, headache, diarrhea and lower abdominal pain was similar in the two groups. CONCLUSIONS: Our results indicate that 75 mg mifepristone in capsule form combined with 600 microg misoprostol is as effective and safe as 150 mg mifepristone in tablet form for the termination of pregnancy up to 49 days.     

Early pregnancy termination with mifepristone and misoprostol in Norway.

OBJECTIVES: Medical abortion was first introduced in Norway in April 1998. The aims of this study were to assess the efficacy, side effects, and acceptability of medical abortion using mifepristone orally and misoprostol vaginally in a Norwegian population. DESIGN: The study included the first 226 pregnant women with gestational age of <63 days who requested nonsurgical abortion during the first year in the first Norwegian hospital using this regimen. METHODS: All women received a single dose of mifepristone 600 mg orally, followed at 48 hours by 800 microg misoprostol vaginally. Treatment outcome and complications were the principal outcome measures. We also measured the rates of side effects such as abdominal pain and bleeding and the women's acceptability of treatment. RESULTS: Abortion was successful in 95%, surgical evacuation became necessary in 4%, and the pregnancy continued in one woman. During the study period the method was chosen by 23% of those requesting abortion before 63 days amenorrhea; 80% would use the method again; 81% would recommend it to a friend; in retrospect, 69% would not have been willing to be randomly allocated to either a medical or a surgical method. CONCLUSIONS: The combination of orally administrated mifepristone and vaginally administrated misoprostol is an abortion method that is both effective and safe, has few side effects and is well accepted by Norwegian women.     

Medical termination of pregnancy at 63 to 83 days gestation.

OBJECTIVE: To assess the efficacy of a medical regimen for the termination of pregnancy within the gestational age range of 63 to 83 days. DESIGN: Prospective observational study. SETTING: Gynaecology department within a district general hospital. POPULATION: Women attending the pregnancy advisory clinic between June 1996 and December 1997. METHODS: The medical regimen used was mifepristone 200 mg orally followed after 36 to 48 h by misoprostol 800 microg administered vaginally. MAIN OUTCOME MEASURES: The success rate of the medical termination of pregnancy regimen, where success was defined as achieving complete abortion without the need for secondary intervention by either surgical or repeat medical means. RESULTS: Primary medical termination of pregnancy was chosen by 253 (80.8%) of the 313 women and was successful in 239 (94.5%). Repeat medical treatment achieved completion of the abortion in a further three women (1.2%) and surgical evacuation of the uterus was required in 10 (4.0%). One woman declined further intervention after failed medical treatment but subsequently miscarried. CONCLUSIONS: The combination of mifepristone and misoprostol is effective for the termination of pregnancy for gestations of 63 to 83 days.     

Oral versus vaginal misoprostol administered one hour before surgical termination of pregnancy: a randomised controlled trial

OBJECTIVE: To assess the efficacy of oral and vaginal misoprostol as cervical priming agents administered 1 hour before first trimester surgical termination of pregnancy. DESIGN: A randomised controlled trial. SETTING: Chelsea and Westminster Hospital, London. POPULATION: Pregnant women of 10 weeks or less gestation attending the termination of pregnancy clinic. METHODS: Ninety eligible women were recruited to the study during September 2001 and September 2002. Women were randomised to one of the three groups: misoprostol administered orally (400 microg), misoprostol administered vaginally (800 microg) and standard care (no cervical priming agent) administered prior to surgical termination of pregnancy. Under general anaesthesia, and prior to the operation, a cervical tonometer was used to determine the main outcome measures. MAIN OUTCOME MEASURES: Baseline cervical dilatation and the cumulative force required to dilate the cervix from 3 to 9 mm. RESULTS: There was no significant difference in the mean baseline cervical dilation (P= 0.16) or the cumulative force required to dilate the cervix (P= 0.12) between the three randomised groups. CONCLUSION: No cervical priming effects were detectable with oral or vaginal misoprostol administered 1 hour before first trimester surgical termination of pregnancy.     

Gemeprost versus misoprostol for cervical priming before first-trimester abortion: a randomized controlled trial

OBJECTIVE: To compare the efficacy of 400 microg of misoprostol with that of 1 mg of gemeprost as cervical priming agents when administered vaginally 3 to 4 hours before first-trimester vacuum aspiration abortion. METHODS: In a prospective controlled trial 90 nulliparous women who requested termination of pregnancy before 12 weeks' gestation were randomized to receive vaginally either misoprostol or gemeprost for cervical priming. The force to dilate the cervix was measured by the use of a cervical tonometer connected to Hegar dilators from 3 to 10 mm. The main outcome measures were baseline cervical dilation; the peak force to dilate the cervix at 8, 9, and 10 mm; and the cumulative force to dilate the cervix to 10 mm. RESULTS: Baseline cervical dilation did not differ significantly between the women who received misoprostol and those who were treated with gemeprost. Neither the peak force required to dilate the cervix at 8, 9, and 10 mm nor the cumulative force to dilate the cervix to 10 mm showed any significant difference between the two groups. CONCLUSION: Vaginally administered misoprostol (400 microg) is as effective as gemeprost (1 mg) for cervical priming 3 to 4 hours before surgical termination of first-trimester pregnancies.     

The use of misoprostol in termination of second-trimester pregnancy

Misoprostol, a synthetic prostaglandin E1 analog, is initially used to prevent peptic ulcer. The initial US Food and Drug Administration-approved indication in the product labeling is the treatment and prevention of intestinal ulcer disease resulting from nonsteroidal anti-inflammatory drugs use. In recent two decades, misoprostol has approved to be an effective agent for termination of pregnancy in various gestation, cervical ripening, labor induction in term pregnancy, and possible management of postpartum hemorrhage. For the termination of second-trimester pregnancy using the combination of mifepristone and misoprostol seems to have the highest efficacy and the shortest time interval of abortion. When mifepristone is not available, misoprostol alone is a good alternative. Misoprostol, 400 μg given vaginally every 3-6 hours, is probably the optimal regimen for second-trimester abortion. More than 800 μg of misoprostol is likely to have more side effects, especially diarrhea. Although misoprostol can be used in women with scarred uterus for termination of second-trimester pregnancy, it is recommended that women with a scarred uterus should receive lower doses and do not double the dose if there is no initial response. It is also important for us to recognize the associated teratogenic effects of misoprostol and thorough consultation before prescribing this medication to patients regarding these risks, especially when failure of abortion occurs, is needed.