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1.
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.  相似文献   

2.
OBJECTIVE: Mifepristone and oral misoprostol are typically used for medical abortion in women up to 49 days of gestation, with a 36- to 48-hour interval between the medications. Alternative routes of misoprostol administration allow for use beyond 49 days of gestation. We designed this randomized, noninferiority trial to compare the efficacy, adverse effects, and acceptability of misoprostol 800 mcg vaginally administered simultaneously with, or 24 hours after, mifepristone 200 mg orally for abortion in women up to 63 days of gestation. METHODS: The 1,128 participants swallowed mifepristone 200 mg and were then randomized to self-administer misoprostol intravaginally immediately in the office (group 1) or 24 hours later at home (group 2). Subjects returned for an evaluation, including transvaginal ultrasonography, 7+/-1 days after initiating treatment. Women who had not aborted were offered a second dose of misoprostol and returned for another evaluation in approximately 1 week. A phone contact was also attempted approximately 5 weeks after treatment. Treatment was considered a failure if a suction aspiration was performed for any indication. RESULTS: The complete abortion rate for group 1 (95.1%, 95% confidence interval [CI] 93.0-96.8%) was statistically noninferior to that for group 2 (96.9%, 95% CI 95.1-98.2%) (P=.003). The abortion rates between groups did not significantly differ by gestational age. Adverse effects were mostly similar, although nausea, diarrhea, and warmth or chills were significantly more common in group 1. CONCLUSION: Mifepristone 200 mg and misoprostol 800 mcg vaginally used simultaneously is as effective for abortion as compared with regimens using a 24-hour dosing interval. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00269568 LEVEL OF EVIDENCE: I.  相似文献   

3.
Objective To examine the clinical efficacy of mifepristone 600 mg followed on the same day or two days later by misoprostol 400μg orally in women undergoing medical termination of pregnancy whose pregnancies have a gestational age up to 49 days.
Design Prospective, randomised trial.
Setting Clinical research office.
Participants Eighty-six women, requesting elective termination of a pregnancy which has a gestational age of  ≤ 49  days.
Methods After administration of mifepristone 600 mg, participants were randomised to take misoprostol six to eight hours later (Group 1) or 48 hours later (Group 2). Women returned for a follow up evaluation  24±1  hours after taking the misoprostol. Participants in Group 1 who had not aborted received a second dose of misoprostol to take 48 hours after the mifepristone. All women returned approximately two weeks after receiving mifepristone. If termination of pregnancy had still not occurred and the pregnancy was non-viable, the woman returned again in three weeks.
Main outcome measures Rate of complete abortion 24 hours after administration of misoprostol.
Results At 24 hours after receiving misoprostol, 21/42 (50%, 95% CI 35%, 65%) women in Group 1 and 40/44 (91%, 95% CI 82%, 99%) women in Group 2 had complete abortions. By follow up two weeks later after the administration of mifepristone, 40/42 (95%, 95% CI 89%, 100%) women in Group 1 and 43/44 (98%, 95% CI 93%, 99%) women in Group 2 were known to have complete abortions. Nausea, vomiting or diarrhoea in women using the standard regimen (Group 2) occurred in 68%, 36%, and 20%, respectively.
Conclusions After treatment with mifepristone 600 mg, administration of misoprostol  400 μg  orally on the same day is not as effective at causing abortion within the first 24 hours compared with the standard time interval of 48 hours between medications.  相似文献   

4.
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。  相似文献   

5.
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  相似文献   

6.
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   

7.
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.  相似文献   

8.
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.  相似文献   

9.
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   

10.
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.  相似文献   

11.
OBJECTIVE: To assess the effect of changing the regimen for second trimester induction of labour from gemeprost to mifepristone/misoprostol. DESIGN and SETTING: A retrospective study at a university teaching hospital over the 5-year period 1993-1997. SUBJECTS, METHODS and REGIMENS: 68 patients, 34 in the gemeprost group and 34 in the mifepristone/misoprostol group. The gemeprost group received 1mg vaginally every 3h to a maximum of five doses. The mifepristone/misoprostol group were pre-treated with 600 mg mifepristone orally followed by 800 microg misoprostol vaginally and then 400 microg orally every 3h to a maximum of four oral doses. MAIN OUTCOME MEASURES: Induction to abortion interval; delivery within 24h. RESULTS: The mifepristone/misoprostol group had a lower induction to abortion interval compared to the gemeprost group (median 8.9h versus 19.8h, respectively, p<0.01). The mifepristone/misoprostol regimen was more successful than the gemeprost regimen; 94% versus 68%, respectively, aborted without extra medical or surgical intervention, p=0.02. There were no significant differences in side effects, analgesia requirements or complications between the two groups. Three patients with previous Caesarean sections had a ruptured uterus; two from the gemeprost group and one from the mifepristone/misoprostol group. CONCLUSIONS: The new mifepristone/misoprostol regimen was more effective in second trimester induction of labour. Induction of labour with misoprostol or gemeprost should be used with care in patients with a previous Caesarean section.  相似文献   

12.
Objective To compare the effectiveness of gemeprost and misoprostol as prostaglandins used in combination with mifepristone for induction of mid-trimester termination.
Design Randomised trial.
Setting Scottish teaching hospital.
Sample One hundred women undergoing abortion between 12 and 20 weeks.
Methods Each woman received 200 mg mifepristone and 36–48 hours later either 1 mg gemeprost vaginal pessary every 6 hours for 18 hours or  4 × 200 μg  misoprostol tablets vaginally followed by  2 × 200 μg  misoprostol tablets orally every 3 hours for 12 hours. Success was defined as the percentage of women aborted within 24 hours of the first administration of prostaglandin.
Main outcome measures Prostaglandin–abortion interval and side effects.
Results There were no significant differences in median prostaglandin–abortion interval between gemeprost (6.6 hours 95% CI 6.0–10.7) and misoprostol (6.1 hours 95% CI 5.5–7.5) (   P = 0.22  ). The cumulative abortion rates at 24 hours (96% vs 94%, respectively), the surgical evacuation rates (12% and 10%) and the incidence of vomiting, diarrhoea and pain were similar.
Conclusion Two hundred milligrammes of mifepristone followed 36–48 hours later by either vaginal gemeprost or misoprostol is a highly effective way of inducing abortion in the second trimester of pregnancy.  相似文献   

13.
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 microg misoprostol administered either orally (n = 119) or vaginally (n = 118). A second dose of 400 microg 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 ofmisoprostol, the route of administration ofmisoprostol did not influence the time to abortion. Of the women who received a second dose ofmisoprostol, 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.  相似文献   

14.
OBJECTIVE: To investigate the adjunctive use of mifepristone in second-trimester induction abortions using misoprostol 1 day after feticidal digoxin. METHODS: This is a randomized, placebo-controlled, double-blind trial of mifepristone in second-trimester induction termination using misoprostol after feticidal digoxin. Women seeking abortion between 18 and 23 weeks of gestation were offered enrollment. At the time of digoxin amnioinfusion, participants received a randomly allocated, identical-appearing capsule containing either mifepristone, 200 mg, or placebo. Patients returned the following day for induction with buccal misoprostol. The primary outcome was the time interval from the first misoprostol dose to abortion. Analysis utilized survival curves with log-rank testing. RESULTS: Of 64 women, 32 received mifepristone and 32 received placebo. The groups did not differ by ethnicity, age, parity, reason for termination, or gestational age. Median procedure time was significantly shorter for those who received mifepristone, 10 hours (95% confidence interval [CI] 8-12), than those who did not, 18 hours (95% CI 15-22), P<.01, and those parous, 10 hours (95% CI 9-14), compared with nulliparous, 16 hours (95% CI 12-22, P=.02). Other findings in the mifepristone compared with placebo group included rates of placental retention, 3.1% compared with 6.3% (P=.61), length of hospitalization, 0.66 days compared with 0.8 days (P=.23), and analgesic requirements, 27.2 mg compared with 39.3 mg morphine (P=.22). Side effects during induction were similar between groups. CONCLUSION: Addition of mifepristone in second-trimester termination inductions using misoprostol significantly reduces the abortion time interval. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00382538 LEVEL OF EVIDENCE: I.  相似文献   

15.
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.  相似文献   

16.
OBJECTIVE: To compare the efficacy of 100 microg of oral misoprostol with 3 mg prostaglandin E2 vaginal tablets in term labour induction. DESIGN: A non-blinded, randomised, controlled trial. SETTING: A tertiary level, teaching Scottish Hospital. POPULATION: Two hundred women at term with indications for labour induction and modified Bishop's cervical score of less than 8. METHODS: The women were randomly allocated to receive either 100 microg of misoprostol orally (which could be repeated 4 hourly to a maximum of five doses if indicated), or a 3 mg tablet of prostaglandin E2 vaginally (which could be repeated in 6 hours, according to routine departmental protocol). MAIN OUTCOME MEASURE: The number delivering vaginally within 24 hours of the induction. RESULTS: Seventy-five women delivered vaginally in the misoprostol group and 73 in the PGE2 group. Of these, 50.7% in the misoprostol group and 54.8% in the PGE2 group delivered within 24 hours of the induction (RR 0.92, 95% CI 0.7 to 1.3). More women in the misoprostol group were given oxytocin, but this was not statistically significant (60%vs 47%, RR 1.3, 95% CI 0.98 to 1.7). Two women in the misoprostol group had uterine hyperstimulation. The neonatal outcomes were not significantly different in the two groups. There was a pound 1100 saving on direct drug costs in the misoprostol group. CONCLUSIONS: Oral misoprostol (100 microg) has similar efficacy to vaginal PGE2 tablets, and may be an option to consider for term labour induction.  相似文献   

17.
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.  相似文献   

18.
OBJECTIVE: To assess the efficacy of medical abortion performed according to a single protocol from 5 through 14 weeks. STUDY DESIGN: Retrospective observational study of medical abortions through 14 weeks performed from January 2000 through August 2001. The protocol combined 400mg of mifepristone orally, followed 48 h later by 800 microg of misoprostol, administered vaginally, and repeated after 4 h if the patient did not begin to abort. Outcome measures were the abortion rate, the rates of immediate manual uterine revision and of secondary vacuum aspiration, the time to expulsion, the misoprostol dose, and analgesic use. RESULTS: The study included 512 medical abortions. The abortion rate was 98.4% and the secondary vacuum aspiration rate 8.2%. The uterine exploration rate was 1.4%, but these occurred only at gestations above 13 weeks. The mean time to expulsion was 4.4+/-1.9 h (1-28), and the mean misoprostol dose 860+/-180 microg (0-2000). None of the characteristics studied differed significantly as a function of gestation. 1.6% of patients had complications. CONCLUSION: Medical abortion was consistently effective through 14 weeks and can be offered as an alternative to the surgical technique.  相似文献   

19.
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.  相似文献   

20.
In this prospective randomized parallel group study, subjects with a pregnancy of less than 63 d were randomized to receive either (i) 200?mg oral mifepristone plus 400?μg misoprostol per vaginally concurrently (group A); (ii) or the administration of misoprostol after 48?h (group B). Transvaginal sonography was performed on the 14th day of misoprostol administration to confirm complete abortion. The primary outcome was to compare the rates of complete abortion in two groups. Secondary outcomes were to compare induction abortion interval, side effects and compliance. A total of 200 subjects included in the study were randomized into groups A and B (100 each). Both the groups were comparable for age, parity, gestational age and history of previous abortion. The complete expulsion rate in group A was 96% (95% confidence interval (CI) 95.1–98.2%) and group B was 95% (95% CI 93.0–96.8%) (p?>?0.100). A gestational age of more than 56 d was found to predict failure of treatment in both groups. The adverse effect profile in the two groups was the same. Efficacy of concurrent mifepristone and misoprostol in combination is similar to that when misoprostol is given 48?h later (ctri.nic.in CTRI/2010/091/001422).  相似文献   

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