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  • Title: Randomized trial of two doses of the prostaglandin E1 analog misoprostol for labor induction.
    Author: Farah LA, Sanchez-Ramos L, Rosa C, Del Valle GO, Gaudier FL, Delke I, Kaunitz AM.
    Journal: Am J Obstet Gynecol; 1997 Aug; 177(2):364-9; discussion 369-71. PubMed ID: 9290452.
    Abstract:
    OBJECTIVE: Our purpose was to compare the safety and effectiveness of intravaginally administered misoprostol at doses of 25 micrograms and 50 micrograms for indicated labor induction in patients with an unfavorable cervix. STUDY DESIGN: Three hundred ninety-nine patients received either 25 micrograms or 50 micrograms of misoprostol, placed intravaginally in the posterior fornix, in this randomized double-blind trial. The dose was repeated every 3 hours until adequate labor was achieved (at least three contractions in 10 minutes). RESULTS: Among 399 patients evaluated, 192 patients were allocated to the 25 micrograms group and 207 patients to the 50 micrograms group. The start-to-delivery interval was shorter in the 50 micrograms group (826 minutes vs 970 minutes, p = 0.02). The incidence of vaginal delivery after one dose was higher in the 50 micrograms group (38.2% vs 25.0%, p = 0.007). Patients receiving 25 micrograms required oxytocin augmentation more frequently than did those receiving 50 micrograms (27.1% vs 16.9%, p = 0.02). No differences were noted in the cesarean or other operative delivery rates among patients in the two treatment groups. The incidence of newborns with a cord pH < 7.16 was greater in the 50 micrograms group (13.0% vs 6.8%, p = 0.04). Although the incidence of hyperstimulation was similar between the groups, the incidence of tachysystole was higher in the 50 micrograms group (32.8% vs 15.6%, p = 0.0001). CONCLUSIONS: Although a dose of 50 micrograms is associated with a shorter start-to-delivery interval and a higher incidence of vaginal delivery after one dose, 25 micrograms of intravaginal misoprostol is effective and associated with a lower incidence of tachysystole and cord pH values < 7.16. The safety and effectiveness of 25 and 50 mcg of intravaginally administered misoprostol for cervical ripening and labor induction were evaluated in a randomized double-blind trial involving 395 US women. The most frequent indications for labor induction in both dosage groups were pregnancy-induced hypertension and premature rupture of the membranes. The prostaglandin dosage was repeated every 3 hours until labor was induced. The mean start-to-delivery interval among the 192 women in the 25 mcg group was 970 minutes, compared to only 826 minutes among the 207 women in the 50 mcg group. 82% of women in the 25 mcg group and 84% of those in the 50 mcg group were delivered within 24 hours. The incidence of vaginal delivery after 1 dose was higher in the 50 mcg group (38.2%) than in the 25 mcg group (25.0%) and women in the lower-dose group required oxytocin administration more frequently than those in the 50 mcg group (27.1% and 16.9%, respectively). On the other hand, the incidence of newborns with a cord pH under 7.16 was greater in the 50 mcg group (13.0%) than in the 25 mcg group (6.8%), and the incidence of tachysystole was higher (32.8% and 15.6%, respectively). Thus, despite the greater effectiveness of the 50 mcg dosage, a regimen of 25 mcg of misoprostol administered intravaginally every 3 hours is indicated to minimize neonatal morbidity.
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