A multicentre randomized comparative clinical trial of 200 mg RU486 (mifepristone) single dose followed by either 5 mg 9-methylene PGE(2) gel (meteneprost) or 600 microg oral PGE(1) (misoprostol) for termination of early pregnancy within 28 days of missed menstrual period. ICMR Task Force Study. Indian Council of Medical Research.

2区 · 医学

Article

A multicentre, randomized, comparative clinical trial of 200 mg RU486 (Mifepristone) followed 48 h later by either 5 mg 9-methylene PGE(2) vaginal gel (meteneprost) or 600 microg oral PGE(1) (misoprostol) for termination of pregnancy within 28 days of the missed period, was carried out through the Indian Council of Medical Research's (ICMR) network of Human Reproduction Research Centres (HRRCs). A total of 893 subjects were assessed regarding their therapeutic responses to the two different treatment groups. The results indicated a success rate of 84.6% among 453 women treated with RU486 followed by 9 methylene PGE(2) vaginal gel, that was not significantly different from the success rate of 87.7% observed in 440 women treated with RU486 followed by oral PGE(1). The majority of study subjects (90%) started bleeding within 72 h. About 26% of the subjects had started bleeding before the administration of any prostaglandin. The average duration of bleeding in all the subjects was about 7 days. No life threatening side effects were observed among the subjects in two treatment groups. Gastro-intestinal complaints were reported more often by women treated with oral PGE(1) as compared to those treated with 9-methylene vaginal PGE(2) gel; nausea occurred in 25.7% and 19.2%, vomiting in 6.8% and 4.6%, and diarrhoea in 4.8% and 0.9% of the subjects in the 2 treatment groups, respectively. Fever higher than 38 degrees C and severe abdominal pain were reported by 4.2% and 5.0% of all subjects treated, respectively. Intravenous infusion of glucose and saline was required by 6 subjects in each treatment of the prostaglandin treated groups. Blood transfusion was required in 2 subjects, one in each treatment group, for profuse bleeding.

1999-01-01·Advances in Contraception

Early abortion by mifepristone (RU 486) followed by vaginal gel (meteneprost) versus oral (misoprostol) prostaglandin.

Article

作者: K. Buckshee ; R. Sehgal ; N. Agarwal ; D. Takkar

The present study was conducted to compare the therapeutic regimens of low-dose mifepristone (200 mg) plus vaginal meteneprost versus oral misoprostol in terms of efficacy and safety for medical termination of early pregnancy. A randomized clinical trial was conducted by the Department of Obstetrics and Gynecology at the All India Institute of Medical Sciences, New Delhi. A total of 101 subjects were enrolled within 56 days of amenorrhea. A single dose of 200 mg of mifepristone (RU 486) was given and, 48 hr later, prostaglandin was administered as either 5 mg of 9 methylene PGE2 vaginal gel, meteneprost (classified as group I) or 600 microg of oral PGE1 derivative misoprostol (classified as group II). In group I, 50 subjects and in group II, 51 subjects were treated with the respective schedule. The success rate with mifepristone + misoprostol (group II) was 88.63% which was significantly higher than that with mifepristone + meteneprost (group I) which was 82% (p < 0.05). The average duration of bleeding in cases with complete abortion was 8.95+/-5.67 and 9.77+/-6.51 in group I and II, respectively. There were no serious side-effects. Only one subject in group I (2%) required blood transfusion for heavy bleeding. This study indicated that oral prostaglandin after a low dose of mifepristone (200 mg) could be developed into an effective method to terminate early pregnancy. Oral administration of both drugs would be a more convenient, feasible, private and acceptable regimen.

1990-10-01·European Journal of Obstetrics & Gynecology and Reproductive Biology4区 · 医学

Termination of early pregnancy through a combination of the antiprogestin and prostaglandin analogue

4区 · 医学

Article

作者: Catherine Dubois ; Anne Goepp ; Françoise Stampf ; Bernard Maria

Termination of early pregnancy (less than 49 days of amenorrhea) was induced in 75 patients with the combination of the antigestagen mifepristone and a prostaglandin analogue, meteneprost. After 48 h a single oral dose of 600 mg of mifepristone was followed by a 10 mg meteneprost vaginal pessary. Pregnancy was confirmed by clinical and ultrasound examinations and plasma HCG assessment. Complete abortion occurred in 72 patients (96%) and the three others required a surgical uterine aspiration. Bleeding continued for 4 to 12 days (mean = 8). Uterine pain and side effects occurred during the 3 h following the use of prostaglandin. Only minor analgesic were required in 30 patients. The combination of mifepristone and meteneprost is a safe and effective method to terminate an early pregnancy.

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