A randomized trial of mifepristone in combination with misoprostol administered sublingually or vaginally for medical abortion at 13-20 weeks gestation

BACKGROUND: Several studies have now reported the successful use of the sublingual administration of misoprostol for medical abortion in the first trimester. The objective of this study was to assess the acceptability to women, the efficacy of the regimen, as well as the acceptability to staff of sublingual versus vaginal administration of misoprostol following mifepristone for medical abortion at 13-20 weeks gestation. METHODS: Women were randomized by opening consecutive sealed envelopes generated using random number tables. Mifepristone (200 mg) was followed 36-48 h later by sublingual administration of misoprostol 600 microg or vaginal misoprostol 800 microg. This was followed by 3 hourly doses of misoprostol 400 microg administered sublingually or vaginally. RESULTS: A total of 76 women were randomized. Of women in the sublingual group, 24 (66.7%) expressed satisfaction with the route of misoprostol administration compared with 25 (62.5%) in the vaginal group. A higher proportion in the sublingual group used intramuscular opiates. There was no significant difference in the surgical evacuation rate between the sublingual (three out of 36 women, 8.3%) and vaginal groups (one out of 40, 2.5%), (P=0.26) and acceptability to staff was the same for both methods. CONCLUSIONS: Sublingual administration of misoprostol following mifepristone is an acceptable and effective alternative to vaginal administration for medical abortion at 13-20 weeks gestation. However, women should be advised about the greater likelihood of requiring stronger analgesia.     

A prospective randomized,double-blinded,placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy

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.     

Pregnacny: The abortifacient effect of misoprostol in the second trimester. A randomized comparison with gemeprost in patients pre-treated with mifepristone (RU486)

The objective of this work was to study the abortifacient effectsof misoprostol, an orally active prostaglandin E₁ (PGE₁) analogue,in the second trimester. A randomized study of two prostaglandinregimens in women pre-treated with the antiprogesterone mifepristonewas carried out in the gynaecological wards of Aberdeen RoyalHospitals, NHS Trust, and included 60 women at 13–20 weeks‘gestation, in whom termination of pregnancy had been agreed.Following pre-treatment with mifepristone 600 mg women wererandomly allocated to one of two prostaglandin regimens whichstarted 36–48 h later. The first misoprostol 400 µgorally (up to three doses) followed by gemeprost vaginal pessary1 mg up to two doses. The second was gemeprost vaginal pessary1 mg up to five doses. The main outcome measures were successrate induction-to-abortion interval and side-effects. Therewere no significant differences between the two groups in anyof the main outcome measures. We conclude that misoprostol isa stable, cheap PGE₁ analogue with demonstrable efficacy andacceptable side-effects in the management of second trimesterabortion. Further work is needed to establish the optimum doseand regimen.     

Pregnancy: The effect of dose of mifepristone and gestation on the efficacy of medical abortion with mifepristone and misoprostol

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 interval90.4–95.5%) 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 women50–63 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.     

Endocrinology: Randomized trial of misoprostol and cervagem in combination with a reduced dose of mifepristone for induction of abortion

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)94.9–98.5%, n = 391] and group II (94.6%; 95% CI 92.3–96.9,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.     

Pilot study on the use of sublingual misoprostol with mifepristone in termination of first trimester pregnancy up to 9 weeks gestation

BACKGROUND: A combination of mifepristone and misoprostol provides an effective method of medical abortion for early pregnancy. A new route of administration of misoprostol, the sublingual route, was investigated in this study. METHODS: One hundred women who requested legal termination of pregnancy up to 63 days were given 200 mg of oral mifepristone followed 48 h later by 800 microg (4 x 200 microg tablets) of sublingual misoprostol. RESULTS: Ninety-four women (94%) had a complete abortion with this regimen. There was one ongoing pregnancy. The median duration of vaginal bleeding was 15 days. There were no serious complications. However, lower abdominal pain, diarrhoea, chills and fever were the commonest side-effects with incidences of 89, 42, 38 and 79% respectively. CONCLUSIONS: The combination of mifepristone and sublingual misoprostol is effective for medical abortion up to 63 days gestation. Randomized trials are required to compare its efficacy and side-effect profile with vaginal misoprostol.     

A prospective, randomized, placebo-controlled trial on the use of mifepristone with sublingual or vaginal misoprostol for medical abortions of less than 9 weeks gestation

BACKGROUND: A combination of mifepristone and misoprostol provides an effective method of medical abortion for early pregnancy. This is the first randomized trial comparing the use of sublingual misoprostol with vaginal misoprostol in combination with mifepristone for termination of early pregnancies up to 63 days. METHODS: A total of 224 women who requested legal termination of pregnancy up to 63 days were randomized by computer- generated list into two groups and given 200 mg of oral mifepristone followed 48 h later by either 800 micro g of sublingual (n = 112) or vaginal (n = 112) misoprostol. RESULTS: Complete abortion occurred in 98.2% (95% CI: 93-99) of women in the sublingual group and 93.8% (95% CI: 88-97) in the vaginal group. There were three ongoing pregnancies in the vaginal group but none in the sublingual group. The median duration of vaginal bleeding was 17 days. There was no serious complication. Fever, chills and gastrointestinal side-effects (nausea, vomiting and diarrhoea) were significantly more common in the sublingual group. CONCLUSIONS: The combination of mifepristone and misoprostol is effective for medical abortion up to 63 days. Both the sublingual and vaginal are effective routes of administration. Further randomized trials are required to find out the optimal dose of sublingual misoprostol that can give the highest complete abortion rate and lowest incidence of side-effects.     

Pregnancy: Induction of abortion in the second trimester by a combination of misoprostol and mifepristone: a randomized comparison between two misoprostol regimens

The combination of mifepristone (RU486) and prostaglandin iseffective in the induction of abortion in the second trimester.The optimal regimen is still under development, but is likelyto be characterized by a short induction-to-abortion interval,low incidence of side-effects and high acceptability. We haveinvestigated further whether misoprostol, a synthetic prostaglanginE₁ analogue, can reliably induce second trimester abortion in70 women pre-treated with mifepristone, and whether differentroutes of administration affect the induction-to-abortion interval.Abortion was achieved in 97% [95% confidence interval (CI) 90–100%]of cases without resort to other prostaglandin agents. The meaninduction abortion time for the studied population was 6.4 h(95% CI 5.6–7.0 h). No significant difference was foundbetween two different routes of administration, namely vaginalversus a combination of vaginal and oral. Misoprostol has anumber of advantages over other prostaglandin preparations.We recommend that, following pre-treatment with mifepristone,misoprostol is used as the prostaglandin of choice to induceabortion in the second trimester.     

Early pregnancy termination with vaginal misoprostol before and after 42 days gestation

BACKGROUND: Misoprostol is a prostaglandin E(1) analogue that has been used for medical abortion. We conducted this prospective study to compare the efficacy of vaginal misoprostol for abortion in women at a gestational age of <42 days and in women at a gestational age of 42-56 days. METHODS: A total of 160 women seeking medical termination of a pregnancy of <56 days were enrolled in the study. Medical termination was performed using 800 micro g of vaginal misoprostol, repeated every 24 h for a maximum of three doses. RESULTS: The overall complete abortion rate was 91.3%. In group A (gestation <42 days) complete abortion occurred in 96.3% of women, whereas in group B (gestation = 42-56 days) complete abortion occurred in 86.3% of women (P < 0.025). The two groups did not differ significantly with respect to side-effects (incidence of pain, bleeding, nausea, diarrhoea, fever and headache). Women who had aborted successfully were significantly more satisfied with the method compared with women who did not (P < 0.001). CONCLUSIONS: The vaginal misoprostol-alone regimen is highly effective for women seeking medical abortion of pregnancies of 相似文献   

A comparative study of surgical and medical procedures: 932 pregnancy terminations up to 63 days gestation

The aim of this retrospective study was to compare the efficacy and complications associated with early medical and surgical pregnancy termination. The study population comprised 932 consecutive women undergoing pregnancy termination at gestations of 63 days or less. There were no age or parity differences between the study groups. Medical termination was performed with mifepristone 200 mg orally and misoprostol 800 microgram vaginally; surgical aspiration termination was performed under general anaesthesia. Outcome measures were: surgical curettage for presumed retained products of conception; ongoing pregnancy; and planned and emergency review in the unit. Early medical and surgical termination were associated with a 90.2 and 94.5% complete abortion rate respectively (P = 0.025). The complete abortion rate with medical termination decreased significantly with increasing parity; no such relationship with surgical abortion was found. Women of parity three or more were less likely to have a complete abortion following a medical (83.3%) compared to surgical procedure (97.7%) (P = 0.028). The ongoing pregnancy rate was 0.9% with medical and 0.5% with surgical termination (P = NS). Medical termination was associated with a lower complete abortion rate than surgical termination, particularly for women of higher parity. However, early medical termination allows over 90% of women to avoid the risks of surgical instrumentation of the uterus and anaesthesia.     

A randomized comparison of medical abortion and surgical vacuum aspiration at 10-13 weeks gestation.

BACKGROUND: Since 1991, mifepristone in combination with a prostaglandin analogue has been licensed for termination of pregnancy in the UK at up to 9 weeks amenorrhoea, and since 1995, beyond 13 weeks. Surgical methods are used almost exclusively at 10-13 weeks amenorrhoea. METHODS: A patient-centred, partially randomized, controlled trial was carried out. Those who expressed a strong preference for either medical (n = 15) or surgical (n = 62) abortion were allocated to that method. The remainder agreed to be randomized. The medical method (n = 188) was mifepristone 200 mg followed by misoprostol up to 3 doses, and surgery (n = 180) was by vacuum aspiration under general anaesthesia. Outcome measures included efficacy rates, medical complications within 8 weeks of the procedure, patient preferences and acceptability. RESULTS: Among women who underwent medical abortion, 5.4% required a second procedure compared with 2.1% who had surgery, although this difference was not statistically significant. Side effects experienced were higher in women who underwent medical abortion compared with those who underwent surgery. There were no significant differences in the rates of major complications up to 8 weeks. Prior to termination, 80% of women had a preference for a method, with 72% preferring medical and 28% preferring surgical abortion. Following abortion, 70% of those who underwent medical termination and 79% who underwent surgery would opt for the same method in the future. CONCLUSION: Medical abortion is safe and effective at 10-13 weeks gestation and should be considered an option for those women who wish to avoid surgery and anaesthesia.     

Comparison of vaginal and sublingual misoprostol for second trimester abortion: randomized controlled equivalence trial

BACKGROUND: To identify an effective misoprostol-only regimen for the terminationof second trimester pregnancy, we compared sublingual and vaginaladministration of multiple doses of misoprostol in a randomized,placebo-controlled equivalence trial. METHODS: Six hundred and eighty-one healthy pregnant women requestingmedical abortion at 13–20 weeks' gestation were randomlyassigned within 11 gynaecological centres in seven countriesinto two treatment groups: 400 µg of misoprostol administeredeither sublingually or vaginally every 3 h up to five doses,followed by sublingual administration of 400 µg misoprostolevery 3 h up to five doses if abortion had not occurred at 24h after the start of treatment. We chose 10% as the margin ofequivalence. The primary end-point was the efficacy of the treatmentsto terminate pregnancy in 24 h. Successful abortion within 48h was also considered as an outcome along with the induction-to-abortion-interval,side effects and women's perceptions on these treatments. RESULTS: At 24 h, the success (complete or incomplete abortion) ratewas 85.9% in the vaginal administration group and 79.8% in thesublingual group (difference: 6.1%, 95% CI: 0.5 to 11.8). Thus,equivalence could not be concluded overall; the difference,however, was driven by the nulliparous women, among whom vaginaladministration was clearly superior to sublingual administration(87.3% versus 68.5%), whereas no significant difference wasobserved between vaginal and sublingual treatments among parouswomen (84.7% versus 88.5%). The rates of side effects were similarin both groups except for fever, which was more common in thevaginal group. About 70% of women in both groups preferred sublingualadministration. CONCLUSIONS: Equivalence between vaginal and sublingual administration couldnot be demonstrated overall. Vaginal administration showed ahigher effectiveness than sublingual administration in terminatingsecond trimester pregnancies, but this result was mainly drivenby nulliparous women. Fever was more prevalent with vaginaladministration. Registered with International Standard RandomizedControlled Trial number ISRCTN72965671 [controlled-trials.com] .     

A prospective randomized comparison of sublingual and oral misoprostol when combined with mifepristone for medical abortion at 12-20 weeks gestation

BACKGROUND: Sublingual misoprostol has been shown to be effective in medical abortion. A prospective double-blinded placebo-controlled trial was done to compare the efficacy and side-effects of sublingual to oral misoprostol when used with mifepristone for medical abortion from 12 to 20 weeks gestation. METHODS: A total of 120 women at 12-20 weeks of gestation were randomized to receive 200 mg oral mifepristone followed by either sublingual or oral misoprostol 400 mg every 3 h for a maximum of five doses 36-48 h later. The course of misoprostol was repeated if the woman did not abort within 24 h. RESULTS: There was no significant difference (P = 0.43) in the success rate at 24 h [relative risk = 1.075; 95% confidence interval (CI): 0.94-1.19]. Abortion occurred in 91.4% in the sublingual group (95% CI: 81.0-96.7%) as compared to 85.0% (95% CI: 73.7-92.1%) in the oral group. The median induction-to-abortion interval was significantly shorter (P = 0.009) in the sublingual group (5.5 h) as compared to the oral group (7.5 h). The incidence of fever was higher in the sublingual group (P < 0.0001). The incidences of other side-effects were similar. CONCLUSION: Sublingual misoprostol, when combined with mifepristone, is effective for medical abortion in the second trimester. The induction-to-abortion interval is shorter when sublingual misoprostol is used when compared to oral misoprostol.     

The effect of non-steroidal anti-inflammatory drugs on medical abortion with mifepristone and misoprostol at 13-22 weeks gestation

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) inhibit the biosynthesis of prostaglandins and concerns have been expressed that they might attenuate the effects of exogenous prostaglandins. This randomized study was conducted to evaluate whether NSAID given during medical abortion with mifepristone/misoprostol in the second trimester has a negative effect on the efficacy of the abortifacient by prolonging the induction-to-abortion interval. METHODS: Seventy-four women were treated with the anti-progesterone mifepristone, followed by repeated doses of misoprostol 36-48 h later. They were randomized to receive a prophylactic pain treatment of either paracetamol and codeine or diclofenac with the first dose of misoprostol. RESULTS: Co-treatment of NSAID with misoprostol did not attenuate the efficacy of mifepristone and misoprostol. There was no significant difference between the NSAID and the non-NSAID group in the induction-to-abortion interval (5.4 versus 6.5 h) or the total doses of misoprostol needed (2 versus 3). The frequency of surgical intervention was similar (55.6 versus 52.6%). Women in the group treated with NSAID required significantly less opiates (P = 0.042). CONCLUSION: Co-treatment with NSAID and misoprostol does not interfere with the action of mifepristone and/or misoprostol to induce uterine contractions and pregnancy expulsion in medical abortion. Prophylactic NSAID administration reduces the need for opiate injections.     

The kinetics of serum hCG and progesterone in response to oral and vaginal administration of misoprostol during medical termination of early pregnancy

BACKGROUND: Misoprostol is widely used in combination with mifepristone for medical termination of pregnancy. We studied the endocrine parameters of trophoblast function during medical termination of early pregnancy using mifepristone in combination with oral or vaginal misoprostol. The effect of prolonged misoprostol administration was also examined. METHODS: Thirty-four women, requesting termination of pregnancy and with 相似文献   

Randomized comparison of vaginal (200 microg every 3 h) and oral (400 microg every 3 h) misoprostol when combined with mifepristone in termination of second trimester pregnancy

It is known that when misoprostol is given at 200 microg every 3 h after mifepristone pretreatment, the vaginal route is more effective than the oral route. However, women prefer the oral route. This randomized study was to test our hypothesis that oral misoprostol 400 microg is as effective as vaginal misoprostol 200 microg when given every 3 h in termination of second trimester pregnancy after priming with mifepristone. A total of 142 patients was randomly assigned to group 1 (200 mg mifepristone + 400 microg oral misoprostol every 3 h up to five doses) or group 2 (200 mg mifepristone + 200 microg vaginal misoprostol every 3 h up to five doses). The incidence of side-effects and the preference study were assessed through a standardized questionnaire during and after the abortion. For the oral group, both the incidence of diarrhoea (40.0 versus 23.2%, P = 0.03) and the amount of drug used (1734 compared with 812 microg, P < 0.0001) were significantly higher than that of the vaginal group but the incidence of fever appeared to be lower (not significant). There was no significant difference in complete abortion rate: 81.4% in the oral group and 75.4% in the vaginal group. The median induction-abortion interval was similar in the two groups (10.4 versus 10.0 h). The percentage of women who aborted in 24 h was also similar: 57/70 (81.4%) in the oral group and 58/69 (87.0%) in the vaginal group. Overall, 82.0% of women preferred the oral route. Oral misoprostol (400 microg) given every 3 h up to five doses, when combined with mifepristone, was as effective as the vaginal (200 microg) route in second trimester termination of pregnancy. This regimen could also be offered to those women who found repeated vaginal administration unacceptable.     

Once-a-month treatment with a combination of mifepristone and the prostaglandin analogue misoprostol

In this two centre study, the efficacy of 200 mg mifepristone orally followed 48 h later by 0.4 mg misoprostol orally for menstrual regulation was investigated. The dose of mifepristone was taken the day before the expected day of menstruation. Each volunteer was planned to participate for up to 6 months. A plasma beta human chorionic gonadotrophin (HCG) was measured on the day of mifepristone intake. The study was disrupted prematurely due to low efficacy. In 125 treatment cycles the overall pregnancy rate was 17.6% (22 pregnancies) and the rate of continuing pregnancies (failure) was 4.0%. Eight women discontinued the study due to bleeding irregularities which were seen in 15 cycles (12%). These effects on bleeding pattern made the timing of treatment day difficult. Late luteal phase treatment with a combination of mifepristone and misoprostol is not adequately effective for menstrual regulation.     

A randomized double-blind placebo-controlled study to assess the effect of oral contraceptive pills on the outcome of medical abortion with mifepristone and misoprostol

This was a randomized double-blind placebo-controlled trial to determine the effect of oral contraceptive (OC) pills taken immediately after medical abortion on the duration of bleeding and complete abortion rate. Two hundred women in the first 49 days of pregnancy were given 200 mg mifepristone orally followed by 400 microg misoprostol vaginally 48 h later. One day later, they were randomized to receive either OC pills (30 microg of ethinyl oestradiol and 0.15 mg of levonorgestrel per tablet) or placebo for 21 days. The complete abortion rates were 98% in the OC group and 99% in the placebo group. The median duration of bleeding was similar: 17 (range: 5-57) days in the OC group and 16 (range: 6-55) days in the placebo group. In the OC group there was a small but significant fall in the haemoglobin concentration by 14 days (5.3 g/dl) after administration of mifepristone. The incidence of side-effects was similar in the two groups. We conclude that the use of OC pills does not decrease the duration of bleeding after medical abortion nor does it affect the abortion rate.     

Pilot study on the use of repeated doses of sublingual misoprostol in termination of pregnancy up to 12 weeks gestation: efficacy and acceptability

BACKGROUND: A sublingual misoprostol-alone regimen was used in 50 women requesting medical abortion at up to 12 weeks gestation. The efficacy and acceptability of this regimen were studied. METHODS: The women were given 600 microg misoprostol sublingually every 3 h for a maximum of 5 doses. RESULTS: The overall complete abortion rate was 86% (95% confidence interval: 74-93). The mean number of doses of misoprostol required was 4.1 +/- 1.1. There was no significant change in haemoglobin concentration and the median duration of vaginal bleeding was 15 days (range: 7-56). Diarrhoea, fever and chills were the most common side-effects. The acceptability of this regimen of misoprostol was good: 97.7% of the women who had a complete abortion would choose this method again and 88.4% would recommend it to others. They preferred sublingual misoprostol as it is convenient to take, avoids the painful vaginal administration and gives more privacy during the abortion process. CONCLUSION: This regimen of sublingual misoprostol is an effective and acceptable method of medical abortion. Randomized controlled trials are required to compare the efficacy of various misoprostol-alone regimens of medical abortion. Pharmacokinetic studies and clinical trials are needed to find out the most appropriate dose, dosing interval and route of administration of misoprostol.     

Medical management of early fetal demise using a combination of mifepristone and misoprostol

BACKGROUND: This study aims to assess the efficacy of a combination of mifepristone and misoprostol in the management of missed miscarriage and anembryonic pregnancy. METHODS: Data of 220 consecutive women with miscarriage, undergoing medical evacuation of the uterus were collected prospectively at an early pregnancy assessment unit in a tertiary referral hospital. 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, two further doses of misoprostol, 400 microg each, were administered vaginally or orally at 3 h intervals. Women who failed to pass products of conception were offered repeat medical regime with misoprostol. Success was defined as complete uterine evacuation within 3 days, without the need for surgical evacuation. RESULTS: The overall success rate of medical management was 84.1%. Mifepristone alone induced natural expulsion of products of conception in 18.1% of women. The median dose of misoprostol required was 1600 microg and the median induction miscarriage interval after first prostaglandin administration was 8.04 h (range: 0.58-50.54 h). Of the 142 women who were symptomatic at presentation the medical regime failed in 30 (21.1%), compared with five (6.4%) failures of the 78 who were asymptomatic (P = 0.007). Of the 35 women who had surgical evacuation, eight required an emergency curettage for bleeding. CONCLUSIONS: The combination of oral mifepristone 200 mg with vaginal or oral misoprostol is an alternative to surgical management of early fetal demise, although it is not as effective as surgery.