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  • Title: Induction of therapeutic abortion in early pregnancy with mifepristone in combination with prostaglandin pessary.
    Author: Rodger MW, Baird DT.
    Journal: Lancet; 1987 Dec 19; 2(8573):1415-8. PubMed ID: 2891991.
    Abstract:
    Therapeutic abortion was induced in 100 women in early pregnancy (less than 56 days' amenorrhoea) with a combination of the antigestagen mifepristone (RU 486) and a synthetic prostaglandin analogue, gemeprost. Mifepristone in oral doses of 400-600 mg was followed 48 h later by a gemeprost vaginal pessary (0.5-1.0 mg). Bleeding was induced in all women 22-70 h after the mifepristone dose and although bleeding continued for 4-43 days (median 12) the total measured blood-loss was only a median of 72.5 ml (range 15-398). Complete abortion occurred in 95 women. Surgical evacuation of the uterus for minimum debris was required in the remaining 5. Only 10 women had diarrhoea or pain that required opioid analgesia. The combination of mifepristone and gemeprost provides a safe and effective alternative to surgical evacuation of the uterus for therapeutic abortion in early pregnancy. A combination of the antigestagen mifepristone (RU 486) and a synthetic prostaglandin analogue, gemeprost, was used to induce therapeutic abortion in 100 women in early pregnancy. Local family planning services and general practitioners in Edinburgh referred women of less than 56 days' amenorrhea who had requested abortion. Pregnancy was confirmed by measurement of the serum level of human chorionic gonadotropin. Group I (n=20) received 150 mg mifepristone orally each day for 4 days. Groups II (n=30), III (n=30), and IV (n=20) received a single oral dose of mifepristone, 400 mg, 500 mg, or 600 mg, respectively. Samples of peripheral blood were collected at recruitment for measurement of the concentration of hemoglobin, urea, electrolytes, cortisol, and HCG and for liver function tests. Blood also was taken for estradiol and progesterone essay from women in Groups II, III, and IV. Each woman recorded symptoms in a diary from the day prior to the start of treatment. Study participants were reviewed 1, 2, and 4 weeks after treatment and discharged from followup after the onset of the next menstrual period. The effectiveness of the 4 treatment regimens was similar. Only 10 (14%) of the 74 women who received half a gemeprost pessary required the 2nd half. 95 of the women aborted completely; 5 women needed surgical intervention. Data were pooled for analysis because there was no significant difference between the 4 groups in the onset of bleeding and pain, requirement for analgesia, side effects, duration of bleeding, measured blood loss, and the time until the next menstrual period. The 94 women who experienced pain became aware of pelvic discomfort 46.6 hours after the initiation of treatment. No patient needed analgesia during the first 48 hours of treatment. After insertion of the pessary, 44 women received an oral analgesic drug and 9 an intramuscular opioid. 47 women did not need an analgesia. There was no significant difference in the frequency of nausea before and during treatment, but there was a significant increase in the incidence of vomiting and of diarrhea. 30 women vomited after the pessary was inserted compared with 13 the day before treatment; 10 women had diarrhea compared with 3 before treatment. No women had clinical evidence of pelvic infection. Liver function tests and cortisol levels were similar prior to and following treatment. Levels of HCG, and estradiol and progesterone decreased significantly after treatment. There were no significant differences in the results between those who needed evacuation and those who did not.
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