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  • Title: Menstrual regulation with prostaglandin (Pg ONO 802) in Indonesia.
    Author: Agoestina T, Sastrawinata S, Prayitno W, Gonta P.
    Journal: Int J Gynaecol Obstet; 1984 Oct; 22(5):403-9. PubMed ID: 6151928.
    Abstract:
    This study was conducted to evaluate the safety, efficacy and acceptability of PGE1 vaginal suppositories (Pg ONO 802) in menstrual regulation. Each vaginal suppository contains 1 mg of 16,16 dimethyl-trans-delta 2 PGE1 methyl ester. Five suppositories were inserted as high as possible into the fornix posterior of the vagina at intervals of 3 h. Five hundred thirty four subjects with delay of menses mostly of up to 14 days were included in the study. Blood chemistry was evaluated and urine analysis performed in all subjects. Success of treatment was assessed on two alternative groups of criteria: (A) induction of bleeding by Pg ONO 802; (B) induction of bleeding achieved by Pg ONO 802 and not followed by surgical intervention. The success rate based on criteria A was 98.9%, and on criteria B 86%. If heavy bleeding occurred and signs of pregnancy were found during the trial period, intervention was made by vacuum aspiration or curettage when necessary. If bleeding did not occur and/or pregnancy continued, treatment was declared a failure and pregnancy was terminated by vacuum extraction or curettage. For non-pregnant subjects no intervention was made but careful re-evaluation was carried out. Mean duration of bleeding after Pg ONO 802 treatment was 6.7 days. Side-effects were generally mild. The incidence of diarrhea was 8.8%, nausea 7.8%, headache 5.8%, vomiting 2.8%; abdominal cramp occurred in as many as 66% of subjects. No treatment was given for these side-effects as they were within acceptable limits.(ABSTRACT TRUNCATED AT 250 WORDS) The safety, efficacy, and acceptability of menstrual regulation with prostaglandin (PG) El vaginal suppositories was investagated in 534 women whose menses was delayed up to 8 weeks from the last menstrual period. 5 suppositories, each containing 1 mg of 16,16 dimethyl-trans-delta 2 PG El methyl ester, were inserted high in the vagina at 3 hour intervals. The success of treatment was assessed by 2 alternate criteria: 1) induction of bleeding, or 2) induction of bleeding and no surgical intervention. The success rate was 98.9% according to the 1st criterion and 86% according to the 2nd criterion. The mean duration of bleeding after treatment was 6.7 days. 47.9% of women experienced moderate bleeding and 43.8% reported heavy bleeding following treatment. Surgical intervention (curettage or vacuum aspiration) was required in 74 of the 528 bleeding cases and in 1 of the 6 nonbleeding cases with positive signs of pregnancy. The surgical intervention was performed because bleeding was considered to be either excessive or prolonged. Side effects tended to manifest themselves between the 1st and 2nd administration of suppositories. Abdominal cramps occurred in 66% of subjects; other side effects were minimal, including vomiting (2.8%), headache (5.8%), nausea (7.8%), and diarrhea (8.8%). These findings suggest that menstrual regulation with PGE1 suppositories is a safe method with the advantages of ease of administration, reversibility, a high success rate, acceptable bleeding duration, only mild side effects, and induction of menses without the need for surgical intervention. The simplicity of vaginal administration offers potential for self-treatment. Use of this method of menstrual regulation could be especially advantageious in countries with restrictive abortion laws. Single administration of a suppository, or parenteral administration, could improve the acceptability of this method.
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