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  • Title: Clinical trial on termination of early pregnancy with RU486 in combination with prostaglandin.
    Author: Wu S, Gao J, Wu Y, Wu M, Fan H, Yao G, Zheng S, Wang P, Du M, Huang Z.
    Journal: Contraception; 1992 Sep; 46(3):203-10. PubMed ID: 1451516.
    Abstract:
    Termination of early pregnancy was performed in 1572 healthy women with RU486 (mifepristone, 600mg orally once), followed 36-60 hours later by administration of methyl ester of dl-15-methyl-PGF2 alpha (PG05, 1mg vaginal suppository). Complete abortion was accomplished in 91.2% (1433/1571), incomplete abortion in 4.8% (76/1571), and continued pregnancy in 3.9% (62/1571). The time elapsed between RU486 intake and complete expulsion was 2.4 +/- 1.3 days. Expulsion took place on the third day in 935 women (72%), and on the 4th day in 273 women (21.0%). Uterine bleeding occurred on the second or third day after RU486 intake in 1256 women (88.8%), and lasted 11.7 +/- 6.4 (SD) days, range 2-55 days. One subject had blood transfusion due to excessive bleeding. The main side effects were nausea/vomiting (22.3%), abdominal pain (10.2%), headache/dizziness (4.1%) and diarrhea (2.8%). Fatal side effects have not been reported in this study. About 73% of subjects with complete abortion assessed the treatment as good to excellent. Even in the failed cases, 25-42% of subjects considered the treatment as good. Further studies are needed to determine the optimal dose of the RU486 regimen. It should be emphasized that the treatment must be used under close medical supervision in order to monitor the uterine bleeding. Researchers analyzed data on 1572 18-44 year old women attending 1 of 10 institutions in 7 provinces and cities in China to examine the side effects of oral administration of 600 mg RU-486 followed by 1 mg of a prostaglandin (PG05) vaginal suppository and this combination's efficacy in terminating early pregnancy. Incomplete abortion occurred in 4.8% of the women; continuation of pregnancy, in 3.9%. 91.2% of the women experienced a complete abortion, which took an average of 2.4 days. Just 3.3% of the women experienced expulsion before insertion of the PG05 vaginal suppository. 81% expelled the fetal sac within 6 hours after PG05 insertion. 88% of women with complete abortion had bleeding on day 2 or 3 and bled on average 11.7 days. 24.5% experienced bleeding for more than 14 days; the bleeding was heavy for 47.4% of them. 1 women bled so profusely she required 2 blood transfusions. The leading side effects were nausea and vomiting (22.3%), abdominal pain (10.2%), headache and dizziness (4.1%), diarrhea (2.8%), and thirst (1.2%). 79.5-96.2% of subjects considered these side effects to be mild or moderate. The side effects persisted for 17-36 hours. None of the women experienced any serious complications that sometimes occur with intramuscularly injected prostaglandins. 92% of the women who experienced complete abortion considered this method to be at least good. The corresponding figure for the incomplete abortion and failed groups was 26.3% and 41.9%, respectively. The researchers concluded that this combination was effective and safe for termination of early pregnancy. They suggested that health workers counsel the women before treatment to increase tolerance of the mild to moderate side effects.
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