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1.

Background

Nonsurgical abortion methods have the potential to improve access to high-quality abortion care. Until recently, availability and utilization of mifepristone medical abortion in low-resource countries were restricted due to the limited availability and perceived high cost of mifepristone, leading some providers and policymakers to support use of misoprostol-only regimens. Yet, this may not be desirable if misoprostol-only regimens are considerably less effective and ultimately more costly for health care systems. This study sought to document the differences in efficacy between two nonsurgical abortion regimens.

Study Design

This double-blind randomized placebo-controlled trial enrolled women with gestational ages up to 63 days seeking early medical abortion from August 2007 to March 2008 at a large tertiary hospital in Ho Chi Minh City, Vietnam. Eligible consenting women received either (1) two doses of 800 mcg buccal misoprostol 24 h apart or (2) 200 mg mifepristone and 800 mcg buccal misoprostol 24 h later. Participants self-administered all study drugs and returned to the hospital for follow-up 1 week later. The trial is registered at ClinicalTrials.gov as NCT00680394.

Results

Four hundred women were randomized to either misoprostol-only (198) or mifepristone+misoprostol (202). Complete abortion occurred for 76.2% (n=147) of women allocated to misoprostol-only vs. 96.5% (n=194) of those given mifepristone+misoprostol (RR 0.79, 95% CI 0.73–0.86). Ongoing pregnancy was documented for 16.6% (32) of misoprostol-only users and 1.5% (3) of mifepristone+misoprostol users (1.62, 0.68–3.90). Side effects were generally similar for both groups, although significantly more women allocated to misoprostol-only reported diarrhea.

Conclusions

Mifepristone+misoprostol is significantly more effective than use of misoprostol-alone for early medical abortion. The number of ongoing pregnancies documented with misoprostol-only warranted an early end of the trial after unblinding of the study at interim analysis. Policymakers should advocate for greater access to mifepristone. Future research should prioritize misoprostol-only regimens with shorter dosing intervals.  相似文献   

2.
Our objective was to evaluate relative differences in direct and total (direct and indirect) costs for medical abortion regimens using mifepristone and misoprostol or misoprostol alone. We created formulas to evaluate relative differences in costs in the United States, Chennai (Madras), India, and a hypothetical developing country based on published protocols and efficacy data. Follow-up visits and suction aspiration procedures in the United States were evaluated over a range of costs. American indirect costs were estimated using earning data. Indirect costs in India and the hypothetical developing country were based on mifepristone cost differences between the United States and India. Although mifepristone costs US dollar 83.33 for every 200-mg tablet in the United States, the actual excess cost of using a mifepristone regimen, as compared with a misoprostol-alone regimen, is only US dollar 22 to US dollar 32. The actual cost of a mifepristone regimen is lower than that of a misoprostol-alone regimen in India. In a hypothetical developing country, a mifepristone regimen is likely to be less expensive than regimens using misoprostol alone. Because of the higher efficacy of medical abortion regimens using mifepristone and misoprostol and the need for fewer follow-up evaluations, such regimens are less expensive or only minimally more expensive than those using misoprostol alone.  相似文献   

3.
Mifepristone dose in the regimen with misoprostol for medical abortion   总被引:2,自引:0,他引:2  
Marions L 《Contraception》2006,74(1):21-25
Medical abortion with the antiprogesterone mifepristone followed by a prostaglandin is highly effective and widely used. The mifepristone dose registered is a single dose of 600 mg followed by a suitable prostaglandin analogue 36-48 h later. The 600-mg dose was chosen arbitrarily, and later studies have proven one third of this dose to be equally effective when combined with a prostaglandin analogue. This report reviews published data on the efficacy of mifepristone in different doses and demonstrates that there are no differences neither clinically nor in pharmacokinetics if the dose is reduced to 200 mg.  相似文献   

4.
BACKGROUND: Simultaneous oral mifepristone and vaginal misoprostol has a 24-h expulsion rate of approximately 90% when used for abortion through 63 days' gestation. This pilot study sought to determine if a simultaneous regimen using buccal misoprostol would be similarly effective and merit further investigation. STUDY DESIGN: One hundred twenty women were enrolled into three equal groups by gestational age: < or =49 days (Group 1), 50-56 days (Group 2) and 57-63 days (Group 3). After swallowing 200 mg of mifepristone, subjects received 800 mcg buccal misoprostol. Participants returned in 24+/-1 h for evaluation of expulsion by ultrasonography. Women with a persistent gestational sac received 800 mcg vaginal misoprostol. Further follow-up occurred at 1, 2 and 5 weeks by telephone or in person, as appropriate. Sample sizes for each group were estimated with the aim of establishing a 24-h expulsion rate of 90% (95% CI=76-95). RESULTS: The 24-h expulsion rates for Groups 1, 2 and 3 were 73% (95% CI=56-85), 69% (95% CI=52-83) and 73% (95% CI=56-85), respectively. Common side effects were nausea (62%), vomiting (33%) and diarrhea (48%), which did not differ by gestational age. Forty-three percent of subjects found the taste of buccal misoprostol objectionable; 30% found buccal retention uncomfortable or inconvenient, and 10% reported oral irritation, sensitivity, numbness or oral ulcers. CONCLUSIONS: Simultaneous oral mifepristone and buccal misoprostol had a lower-than-hypothesized expulsion rate at 24 h. Although overall success rates at 7 or 15 days could have been higher than those observed at 24 h, we believe that this regimen does not warrant further study.  相似文献   

5.
目的研究米非司酮配伍米索前列醇舌下含服及口服的药物流产效果。方法将158例早孕妇女(停经≤56天)随机分为2组,连续口服米非司酮2天,3次/d,每次25mg,第3天上午使用米索前列醇(本文简称米索)口服400μg同时阴道给400μg(组Ⅰ),或者舌下含400μg同时阴道给400μg(组Ⅱ)以终止妊娠。结果总体完全流产率为94.9%,组I为92.5%,组Ⅱ为97.4%,两组无显著性差异(P>0.05);总体不全流产率为4.43%,组I为7.5%(6/80),高于组Ⅱ1.28%(1/78),但两组无显著性差异(P>0.05);总体失败率为0.63%,其中组Ⅰ为0,组Ⅱ为1.28%,两组亦无显著性差异(P>0.05);组Ⅰ从应用米索至孕囊排出时间为(2.39±1.20)h,明显低于组Ⅱ(2.98±1.33)h(P<0.01)。结论组I终止早孕的不全流产率高于组Ⅱ(但无明显组间差异,可能与样本较小有关),可能与舌下含服米索可使有效血药浓度维持时间较长,生物利用度较高有关,故在药物流产中米非司酮配伍舌下含服米索是1种很有前景的用药方法。  相似文献   

6.

Background

A 400 mcg dose of sublingual misoprostol has high efficacy and few side effects when used with 200 mg mifepristone for medical abortion through 63 days' gestation.

Study Design

Eligible and consenting women (n=480) were randomized to 400 mcg of misoprostol sublingually or orally, 24 h after 200 mg of mifepristone. Abortion status was assessed two weeks later.

Results

Complete abortion occurred in 98.7% of the sublingual group and 94.0% of the oral group (p value=.006, RR: 1.05, 95% CI=1.01--1.09). Over 90% of women in both arms expressed high satisfaction with the method. Side effects were similar in both groups, with only fever or chills reported by significantly more women in the sublingual arm.

Conclusions

The sublingual route appears superior to the regimen of 400 mcg misoprostol used orally and may be a good option for mifepristone medical abortion.  相似文献   

7.
Of the total women included in the study, 96 women chose to receive misoprostol 600 microg sublingually while 53 women received misoprostol 800 microg vaginally 36-48 h after receiving mifepristone 200 mg. Complete abortion occurred in 93 women (98.9%) in the sublingual and 51 women (96.2%) in the vaginal group (p = 0.27). The mean induction-to-abortion interval was 3.2 h (SD = 1.4) in the sublingual and 4.1 h (SD = 1.5) in the vaginal group (p = 0.02). The mean gestation at abortion in weeks was 7.1 (SD = 1.0) in the sublingual and 7.7 (SD = 1.3) in the vaginal group (p = 0.003). Women in the sublingual group experienced more vomiting (p = 0.03), diarrhea (p = 0.02) and unpleasant taste in their mouth (p = 0.0001) while those in the vaginal group experienced more headache (p = 0.002). Of women in the sublingual group, 77% were satisfied with the route of misoprostol administration compared to 68% in the vaginal group (p = 0.25). These findings now need to be assessed in the context of a randomized controlled trial.  相似文献   

8.

Background

The administration interval between mifepristone and misoprostol is usually about 36-48 h, which might affect a woman's choice of method of termination. Unwanted outcomes such as uterine bleeding, painful cramps and psychosocial issues which may occur during this long interval can be altered by a shorter administration interval. A shorter interval will be cost-effective as it saves both women's and clinician's time and other resources. If the waiting time interval between therapeutic interventions could be reduced without compromising efficacy, it will potentially improve compliance, patient acceptability and quality of care.

Study design

A systematic review of randomized controlled trials published from 1999 to 2008 was conducted to assess the evidence for a shorter mifepristone and misoprostol administration interval at first trimester medical termination. Searching strategy included MEDLINE, EMBASE, CLINAHL and Cochrane Library. The primary outcome measure was complete abortion without the need for a surgical procedure.

Results

Five randomized controlled trials (RCT) compared the efficacy of mifepristone and misoprostol administration intervals between 0 and 72 h in 5139 participants. The complete abortion rates varied between 90% and 98%. Although the meta-analysis of pooled data of all RCTs shows no statistically significant difference in efficacy between the shorter and longer dosing intervals, there is a trend toward slightly lower success rates with administration intervals earlier than 8 h.

Conclusions

Overall efficacy of complete abortion is not statistically different between the longer and shorter administration intervals. This might encourage the clinician to adopt a ‘flexible policy’ with fully informed consent and consideration of all circumstances.  相似文献   

9.
目的:观察米非司酮配伍米索前列醇治疗妊娠10 ~ 16周稽留流产的疗效,探讨可行性及安全性.方法:收集经B超确诊的孕10~16周稽留流产妇女150例(稽留流产组),要求终止妊娠的10 ~16周正常妊娠者80例(正常妊娠组),两组均采用米非司酮配伍米索前列醇进行药物流产,比较两组治疗效果、清宫率、阴道出血量及不良反应.结果:稽留流产组完全流产121例(80.7%),不全流产23例(15.3%),无效6例(4.0%);正常妊娠组完全流产70例(87.5%),不全流产9例(11.3%),无效1例(1.3%),两组疗效差异无统计学意义(Z=-1.359,P>0.05);稽留流产组清宫率(19.33%)与正常妊娠组(12.50%)比较无统计学差异(x2=1.730,P>0.05),阴道流血量(68.24±27.62ml)高于正常妊娠组(46.81 ±23.37ml)(t=9.147,P<0.05);两组不良反应出现情况无明显差异.结论:米非司酮配伍米索前列醇治疗稽留流产的疗效与终止相同孕周正常妊娠疗效相当,除阴道流血量略高于正常妊娠组外,未增加清宫率与不良反应,具有可靠的疗效与安全性.  相似文献   

10.
In a previous study of 40 women up to 49 days' gestation, our research center demonstrated that mifepristone 200 mg followed on the same day by misoprostol 800 microg vaginally produced abortion at rates similar to standard regimens which administer the two drugs 24 or 48 h apart. We performed this study to evaluate the same regimen in women with pregnancies at 50 to 63 days' gestation. Forty women from 50 to 56 days' gestation (Group 1) and 40 women from 57 to 63 days' gestation (Group 2) inserted misoprostol vaginally 6 to 8 h after taking mifepristone. Participants were instructed to return 24 +/- 1 h after using misoprostol for an evaluation that included transvaginal ultrasonography. Subjects who had not aborted received a second dose of misoprostol to administer 48 h after the mifepristone. All participants were to return 2 weeks later. Ultrasound examinations were performed in those who required a second dose of misoprostol to confirm the abortion was successful. At 24 h after receiving misoprostol, 37/40 (93%, 95% CI 80, 98%) and 36/40 (90%, 95% CI 76, 97%) women from Groups 1 and 2, respectively, had expelled the pregnancy. By follow-up 2 weeks after taking mifepristone, all 40 women in Group 1 (100%, 95% CI 91,100%) and 39/40 women in Group 2 (98%, 95% CI 87,100%) had complete abortions. One woman in the latter group who aborted within the first 24 h had an incomplete abortion treated by suction curettage. This pilot study suggests that mifepristone 200 mg, followed on the same day by misoprostol 800 microg vaginally, effects abortion in women 50 to 63 days' gestation at rates comparable to regimens using longer dosing intervals between medications. Though this regimen is promising, larger randomized trials comparing it to standard regimens are needed before widespread use.  相似文献   

11.
HYPOTHESIS: Simultaneous administration of mifepristone and misoprostol for medical abortion in women up to 49 days gestation will result in complete abortion in 90% of women within 24 h of treatment. MATERIALS AND METHODS: Forty women with pregnancies up to 49 days gestation inserted 800 mug vaginal misoprostol in our office immediately after taking mifepristone 200 mg orally. Follow-up visits, which included vaginal ultrasonography, occurred 24+/-1 h and 2 weeks after treatment. If a gestational sac was still present at the first follow-up visit, the misoprostol dose was repeated. Suction abortion was performed for a viable gestation at the second follow-up visit, presence of a nonviable gestation within 5 weeks of treatment and when clinically indicated. RESULTS: Expulsion occurred in 36/40 (90%, 95% CI 80-99) and 39/40 (98%, 95% CI 93-100) women by the first and second follow-up visits, respectively. One woman who had initially expelled the gestational sac after a single dose of misoprostol later required a suction curettage for an incomplete abortion. CONCLUSION: Simultaneous administration of mifepristone and vaginal misoprostol is a promising regimen for medical abortion up to 49 days gestation.  相似文献   

12.
BACKGROUND: We sought to examine outcomes after a second dose of misoprostol was given at a 1-week follow-up visit after medical abortion for the presence of a persistent gestational sac (GS) on ultrasound examination. STUDY DESIGN: We examined outcomes in women who were enrolled in two randomized trials of medical abortion regimens. Pregnant women up to 63 days' gestation received mifepristone followed by misoprostol 800 mcg vaginally either 24 h later, 6-8 h later or within 15 min. Participants in both studies returned for an evaluation, including transvaginal ultrasonography, approximately 7 days after initiating treatment. We included women with a GS present at the follow-up visit. Subjects who had not expelled the GS received a second dose of misoprostol 800 mcg vaginally. Participants returned approximately 1 week later and were contacted by telephone 5 weeks after treatment. RESULTS: Of 1972 women who had a follow-up ultrasound examination within 11 days of treatment, a persistent GS was identified in 82 women (4.2%) of whom 68 opted to receive a second dose of misoprostol. All 68 women returned for follow-up evaluation and 42 (62%) expelled the GS. In the 26 women with an embryonic pole within the persistent sac, expulsion occurred in 5 (36%) of 14 with and 7 (54%) of 13 without gestational cardiac activity (GCA) (p = .45). Of the 14 pregnancies with GCA, only 5 (36%) had GCA at follow-up. CONCLUSIONS: More than half of women with a persistent GS after medical abortion will expel the pregnancy when treated with a second dose of misoprostol. One-third of women who have a GS with cardiac activity will expel the GS with a second dose of misoprostol, making a second dose a reasonable option.  相似文献   

13.
OBJECTIVE: Mifepristone-misoprostol medical abortion has been approved in the United States since 2000. U.S. providers have preferred to use vaginal misoprostol because of evidence that such a regimen is more effective in later gestations. Buccal administration of misoprostol may be equally effective and more acceptable to some women. METHODS: This open-label, randomized trial was conducted at two sites in Rochester, NY, and involved healthy women with pregnancies through 56 days since the last menstrual period (LMP) as indicated by sonogram. Women received mifepristone 200 mg orally and were randomized to use 800 mug of misoprostol either buccally or vaginally 1 to 2 days later. They returned within 15 days for repeat sonogram. If the woman's pregnancy had not been completely aborted by day 36, a suction abortion was performed. The primary outcome was a complete abortion without surgical intervention. RESULTS: Four hundred forty-two women were enrolled in the study, and complete data were available on 429. The efficacy rate was 95% (205/216) in the buccal group and 93% (199/213) in the vaginal group (chi(2)=0.43, p=.51). Nausea was the most commonly reported side effect, affecting 70% in the buccal group and 62% in the vaginal group. There were no differences in the satisfaction with the overall procedure between the buccal (92%) and the vaginal groups (95%) (chi(2)=1.87, p=.17). CONCLUSION: Buccal administration of misoprostol after low-dose mifepristone for medical abortion appears to be a highly effective and acceptable alternative compared with vaginal administration for medical abortion in pregnancies through 56 days LMP.  相似文献   

14.
Schaff E 《Contraception》2006,74(1):42-44
OBJECTIVES: The aim of this study was to compare regimens that shorten the interval between mifepristone and the prostaglandin misoprostol or gemeprost for medical abortion. METHODS: The Cochrane Controlled Trials Register and MEDLINE were systematically searched for the words mifepristone and abortion. Only randomized controlled trials comparing different mifepristone regimens with either misoprostol or gemeprost were included. The outcome was a complete abortion not requiring surgical evacuation. RESULTS: Five randomized trials were identified and all were published since 1999. Four were from the United States and three had enrollments of >1000. The route of administration of the prostaglandin was used vaginally, except in one study where misoprostol was divided in two doses 2 h apart. Four studies provided information about a 1-day interval and two trials provided information about an interval of 6-8 h evaluating mifepristone 200 mg and misoprostol 800 microg vaginally. There were no significant differences noted between the current 2-day interval compared with the 1-day interval. There was one study suggesting no difference with an interval of 6-8 h. CONCLUSIONS: The interval between mifepristone and misoprostol 800 microg vaginally can be decreased from 48 to 6-8 h without loss of efficacy.  相似文献   

15.
Rossi B  Creinin MD  Meyn LA 《Contraception》2004,70(4):313-317
We performed this analysis to evaluate the ability of both women and their clinicians to predict pregnancy expulsion after using mifepristone and misoprostol for medical abortion up to 63 days gestation. Women who participated in a multicenter, randomized trial comparing misoprostol 6-8 h vs. 23-25 h after mifepristone attended a follow-up visit approximately 7 days after mifepristone treatment. Each subject was asked if she felt she had expelled the gestational sac. Clinicians also assessed if the sac had been expelled based on the woman's history. Vaginal ultrasonography was then performed to assess the uterine cavity. Of the 1080 women enrolled in the multicenter study, 931 (86.2%) who attended the first follow-up visit by study day 12 and did not have a uterine suction aspiration prior to this visit were included in this analysis. Vaginal ultrasonography at the first follow-up visit demonstrated expulsion in 915 [98.3%, 95% confidence interval (CI): 97.2-99.0] women. Overall, sensitivity, specificity, and positive and negative predictive values for subjects were 96.5%, 31.3%, 98.8% and 13.5%, respectively. When both the clinician and patient felt that the gestational sac had passed (n = 880 [94.5%, 95% CI: 92.9-95.9]), expulsion was confirmed by sonography in 99.1% (95% CI: 98.2-99.6) of cases. Women and clinicians are very accurate at determining expulsion of gestational sac during medical abortion with mifepristone and misoprostol without ultrasonography or a physical examination.  相似文献   

16.
The objective of this study was to identify predictors of narcotic analgesic use during medical abortion. Two-thousand-seven-hundred-forty-seven women with pregnancies of 63 days gestational age or less received 200 mg mifepristone followed by at-home use of 800 μg vaginal misoprostol in two consecutive clinical trials in the United States, and also reported their use of analgesics. Overall, 79% of these subjects used narcotic analgesics. Women in the 2nd of the two studies were randomized to use misoprostol 24, 48, or 72 h after mifepristone. Those who were randomized to 24 h were more likely to use narcotic analgesics than those who were randomized to 48 or 72 h. In both studies, the use of narcotic analgesia during medical abortion was less prevalent among parous women and Asian women, and among those with a gestational age of 56 days or less. The clinic providing care for the patient was the most important determinant of narcotic analgesia use, even though the analgesia was used at home. Use of narcotic analgesics in these women undergoing medical abortion at home was more prevalent than use reported in previous studies where women underwent medical abortion in a clinical setting.  相似文献   

17.
INTRODUCTION: In the interest of decreasing the amount of time it takes to achieve a medical abortion, we performed a pilot study to evaluate the simultaneous administration of mifepristone and vaginal misoprostol for women with gestation from 50 to 63 days. MATERIALS AND METHODS: Forty women were enrolled with undesired pregnancies from 50 to 56 days' gestation (group 1) and 40 from 57 to 63 days' gestation (group 2). All women used misoprostol 800 mug vaginally immediately after having swallowed the 200 mg mifepristone tablet. Follow-up evaluations with transvaginal ultrasonography occurred at 24 h and 2 weeks after treatment. RESULTS: The 24-h expulsion rates were 88% (95% CI, 77-98) and 83% (95% CI, 7-94) in groups 1 and 2, respectively. The complete abortion rates at 2 weeks were 93% (95% CI, 84-100) and 90% (95% CI, 81-99), respectively. DISCUSSION: Simultaneous administration of oral mifepristone and vaginal misoprostol provides 24-h expulsion rates in women with gestation from 50 to 63 days, comparable to those reported in the medical literature for standard treatment regimens. Further study of this regimen in a large randomized trial is warranted.  相似文献   

18.
Induced abortion is still a major health problem in the world and the most frequently performed intervention in obstetrics and gynecology with an estimated total of 46 million worldwide each year. Medical abortion with mifepristone and prostaglandin was first introduced in 1988 and is now approved in 31 countries. This combination of drugs has recently been included in the List of Essential Medicines by the World Health Organisation. The present review summarizes the development, physiology and the development of the currently used regimens.  相似文献   

19.
路运珍 《中国妇幼保健》2011,26(24):3752-3753
目的:探讨稽留流产应用米非司酮配伍米索前列醇的临床疗效。方法:选择滕州市中心人民医院收治的稽留流产患者1 960例,随机分为观察组和对照组,每组各980例。观察组口服米非司酮配伍米索前列醇;对照组口服己烯雌酚。根据子宫大小行钳刮术或静脉滴注缩宫素,待其自然排出胎儿、胎盘后行清宫术,观察两组清宫情况。结果:观察组流产成功率为91.84%,对照组流产成功率为59.18%,观察组流产成功率明显高于对照组。结论:米非司酮配伍米索前列醇口服能安全有效地终止稽留流产,具有疗效好、出血量少,方法简便、用药剂量小等优点,可减少术后不全流产的几率,避免人工流产综合征的发生。  相似文献   

20.

Background

From 2001 to March 2006, Planned Parenthood Federation of America (Planned Parenthood) health centers throughout the United States provided medical abortions principally by a regimen of oral mifepristone, followed 24-48 h later by vaginal misoprostol. In late March 2006, analyses of serious uterine infections following medical abortions led Planned Parenthood to change the route of misoprostol administration and to employ additional measures to minimize subsequent serious uterine infections. In August 2006, we conducted an extensive audit of medical abortions with the new buccal misoprostol regimen so that patients could be given accurate information about the success rate of the new regimen.

Objectives

We sought to evaluate the effectiveness of the buccal medical abortion regimen and to examine correlates of its success during routine service delivery.

Methods

In 2006, audits were conducted in 10 large urban service points to estimate the success rates of the buccal regimen. Success was defined as medical abortion without vacuum aspiration. These audits also permitted estimates of success rates with oral misoprostol following mifepristone in a subset in which 98% of the subjects stemmed from two sites.

Results

The effectiveness of the buccal misoprostol-mifepristone regimen was 98.3% for women with gestational ages below 60 days. The oral misoprostol-mifepristone regimen, used by 278 women with a gestational age below 50 days, had a success rate of 96.8%.

Conclusion

In conjunction with 200 mg of mifepristone, use of 800 mcg of buccal misoprostol up to 59 days of gestation is as effective as the use of 800 mcg of vaginal misoprostol up to 63 days of gestation.  相似文献   

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