This open multicenter study was performed in 20 hospital gynecological units in the UK. The effects of 600 mg oral mifepristone as pretreatment to vaginal prostaglandin induction of second second trimester abortion was studied in 267 women.
The primary efficacy variable was the abortion induction interval, defined as the time taken to expel the fetus from the time of administration of the first prostaglandin pessary. Induction was commenced 36 to 48 hours following mifepristone intake.
The mean abortion induction interval was 7 h. A total of 81.9% of women aborted within 12 h. There was a significant relationship between abortion induction interval and age of gestation, and a significant inverse relationship between abortion induction interval and parity.
Vomiting, pelvic pain, and nausea were the most frequently reported adverse events. Two patients required transfusion and one patient with a uterine scar from a previous cesarean section suffered a ruptured uterus and hysterotomy. 相似文献
The maternal and fetal endocrine effects of the maternal administration of the anti-progestin mifepristone in mid-pregnancy have been investigated. Mifepristone and the metabolite RU 42,633 were detected in the fetal circulation and in the amniotic fluid 4, 24 and 48 h after oral ingestion. Maximum fetal plasma concentrations of mifepristone occurred 4 h after treatment indicating rapid placental transfer of the drug. No significant changes in progesterone, cortisol, oestradiol or aldosterone concentrations were detected in the maternal circulation after mifepristone treatment. No significant changes occurred in the fetal progesterone, oestradiol or cortisol concentrations, but a significant increase in fetal aldosterone occurred 4 and 24 h after treatment. The significance of these results is discussed in relation to the possible therapeutic uses of mifepristone for inducing labour. 相似文献
BACKGROUND: Vaginal misoprostol has been shown to be an effective single agent for medical abortion. This randomized, double-blinded, placebo-controlled trial compared a regimen of mifepristone and misoprostol with misoprostol alone for termination of early pregnancy. METHODS: 250 women with gestations < or = 56 days were randomized by a random number table to receive either 200 mg mifepristone orally or placebo followed 48 h later by 800 microg vaginal misoprostol. Administration of misoprostol was repeated every 24 h up to three doses if abortion failed to occur. Abortion success was defined as complete abortion without the use of surgical aspiration. RESULTS: Successful medical abortions occurred in 114 out of 119 subjects (95.7%) after mifepristone followed by vaginal misoprostol. In all, 110 out of 125 subjects (88.0%) successfully aborted after placebo and vaginal misoprostol. The higher success rate of complete abortion with the mifepristone and misoprostol regimen was statistically significant compared with the placebo and misoprostol regimen (P < 0.05). CONCLUSIONS: A regimen of mifepristone and misoprostol was significantly more effective for termination of pregnancies < or = 56 days than misoprostol alone. The 88% efficacy obtained with vaginal misoprostol alone may be clinically acceptable when mifepristone is not available. 相似文献
A combination of the anti-progesterone mifepristone and gemeprostprovides an effective non-surgical method for the inductionof abortion at gestations up to 63 days, achieving completeabortion rates of over 95%. We report our experience with analternate regimen, comprising a reduced dose of mifepristonein combination with vaginal misoprostol. A consecutive seriesof 2000 women requesting early medical abortion at gestationsup to 63 days was studied retrospectively. Each woman receivedmifepristone 200 mg orally, followed 3648 h later bymisoprostol 800 µg vaginally. Of the 2000 women, 39 (2.0%)aborted completely following administration of mifepristonealone and a further 1912 experienced complete abortion followingadministration of misoprostol (a complete abortion rate of 97.5%).Surgical intervention was required in 49 women (2.5%): for incompleteabortion in 27 (1.4%), for missed abortion in seven (0.4%),for continuing pregnancy in 11 (0.6%) and to exclude ectopicpregnancy in four (0.2%). The surgical intervention rate wassignificantly higher among women at gestations 49 days thanamong those at 49 days (3.3 versus 1.5%, P = 0.0193). The regimenappears as effective, in terms of high complete abortion rateand low continuing pregnancy rate, as any published alternative.This regimen has the benefit of being less costly as the doseof mifepristone is 67% lower and misoprostol is substantiallyless expensive than gemeprost. Additionally, misoprostol doesnot require special transport or storage requirements. As such,the combination of mifepristone and gemeprost. 相似文献
The ultrastructural characteristics of peri-implantation stage embryos recovered on day 6 after ovulation from rhesus monkeys with or without mifepristone (RU486) treatment during the early luteal phase were examined in the present study. Monkeys were randomly allocated to two groups; group 1 animals were injected s.c. with 2 ml vehicle (1:4, benzyl benzoate: olive oil, v/v, n = 21) and group 2 animals received a single dose of mifepristone (2 mg/kg body weight, w/v, n = 30) in the same volume of vehicle on day 2 after ovulation in mated cycles. On day 6 after ovulation, female monkeys of both groups were laparotomized and their reproductive tracts were flushed to retrieve preimplantation stage embryos. Embryos that showed frank degeneration or desynchrony on gross microscopical examination were not included in the present study. Preimplantation embryo growth on day 6 after ovulation was significantly (P < 0.05) affected in the morula-blastocyst transition stage in mifepristone-treated monkeys compared with that in the control group of monkeys. Ultrastructurally, administration of mifepristone on day 2 after ovulation depressed preimplantation stage embryo development, characterized by loss of cell polarity, lack of mitochondrial maturity, and lack of differentiation in trophoblast cells. Furthermore, preimplantation embryos from mifepristone-treated animals displayed a higher occurrence of inter-blastomere space, intra-cytoplasmic vacuoles, myelinoid bodies, accumulation of lipid droplets, lysosomes, lipofuscins, autophagosomes and multivesicular bodies. Collectively, it appears that the developmental potential of preimplantation embryos was significantly compromised in mifepristone-treated cycles. 相似文献
Mifepristone (600 mg) in combination with a prostaglandin hasbeen demonstrated to be a safe, acceptable alternative to vacuumaspiration for induction of abortion in the first 9 weeks ofpregnancy. However, the efficacy and side-effects of differentprostaglandins used in combination with mifepristone have notbeen assessed in a randomized trial. In this study, 800 womenseeking an abortion at gestational age 63 days amenorrhoea wererandomized to receive either 0.5 mg gemeprost by vaginal pessary(group I) or 600 µg misoprostol (group II) by mouth 48h after taking 200 mg mifepristone by mouth. The side-effectsand number of complete abortions were used as measures of efficacy.There was no significant difference in the rate of completeabortion between group I [96.7%; 95% confidence interval (CI)94.998.5%, n = 391] and group II (94.6%; 95% CI 92.396.9,n = 386). It was not possible to assess the outcome with certaintyin the remaining 23 women. However, there were significantlymore ongoing pregnancies in the women who received misoprostolthan in those who received gemeprost (nine versus one, P <0.01) and in eight of these 10 women the gestation was >49days. Fewer women in group II required analgesia than in groupI (48 versus 60%, P < 0.001) although the number requestingopiate was similar in each group (6.9 versus 5.2%, P > 0.4).The incidence of nausea and vomiting after misoprostol (47.8and 21.9% respectively) was higher (P < 0.001) than aftergemeprost (33.9 and 12% respectively). The incidence of infectionand heavy bleeding was low in both groups (<2%) and onlyone woman required blood transfusion. We conclude that the recommendeddose of mifepristone and gemeprost can be reduced without impairingclinical efficacy in pregnancies up to 63 days amenorrhoea.Misoprostol is a safe alternative prostaglandin but has a higherincidence of ongoing pregnancies especially at gestation after49 days amenorrhoea. 相似文献
Although it has been demonstrated that a combination of mifepristoneand a prostaglandin is an effective method of inducing abortionin early pregnancy, the optimum dose of the antigestogen isunknown. Women (n = 220) requesting abortion in early pregnancy(63 days amenorrhoea) were randomized to receive a single doseof either 600 or 200 mg mifepristone followed 48 h later bya single dose of 600 µg misoprostol by mouth. The percentageof women who had a complete abortion (93.6% confidence interval90.495.5%) was identical in the two groups. There wasno significant difference in the number of women who passedthe fetus within 4 h of receiving the prostaglandin (64 versus74%), the days of bleeding (14.6 ± 1.1 versus 15.3 ±0.9) nor in the onset of the next period (39.7 ± 1.3versus 36.7 ± 1.3) respectively between the groups receiving200 or 600 mg mifepristone. However, the complete abortion ratewas significantly higher in women 49 days compared to women5063 days amenorrhoea (97.5 versus 89.1% respectively;P < 0.02). There was no difference in any of the other parametersat different weeks of gestation. We conclude: (i) that the recommendeddose of mifepristone could be reduced from 600 to 200 mg withoutloss of clinical efficacy, (ii) that the combination of mifepristoneand 600 µg misoprostol is a highly effective alternativeto vacuum aspiration for inducing abortion in women < 50days amenorrhoea and (iii) at gestation >56 days, this combinationmay result in too many incomplete abortions to be clinicallyacceptable. 相似文献