Outpatient cervical ripening with intravaginal misoprostol1,

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Abstract

Objective: To determine if outpatient cervical ripening using misoprostol can initiate labor within 48 hours of medication administration and to determine if time from medication administration to time of delivery is decreased using outpatient cervical ripening.

Methods: Uncomplicated singleton, vertex pregnancies at 41 weeks’ gestation or later with Bishop score of 4 or less were eligible for enrollment. Other inclusion criteria included intact membranes, less than eight uterine contractions per hour, a reactive nonstress test, and amniotic fluid index (AFI) over 5 cm. After randomization, 25 μcg of misoprostol or placebo was placed within the posterior vaginal fornix. Patients were continuously monitored for 4 hours, then discharged if not in active labor. Patients returned in 24 hours for a repeat administration of the respective medication. Patients not delivered within 48 hours were admitted for inpatient induction of labor. Statistical analysis was performed with the Fisher, Student t, χ2, and Mann-Whitney U tests, with P < .05 considered statistically significant.

Results: Among the 60 patients enrolled, 27 (45%) received misoprostol and 33 (55%) received placebo. The majority (24 of 27, 88.9%) of study group patients entered active labor within 48 hours after dosing, compared with 16.7% (five of 33) of placebo group patients (P < .001). The time from initial dose to delivery was significantly shorter in the misoprostol group (36.9 ± 3.8 compared with 61.3 ± 3.8 hours, P < .001).

Conclusion: Intravaginal misoprostol is effective for outpatient cervical ripening. No adverse effects were encountered, although further study is required to determine the safety of this treatment regimen. (Obstet Gynecol 2000;96:684–8.)

Section snippets

Materials and methods

This clinical study was conducted between December 7, 1997 and December 10, 1999 at Naval Medical Center, Portsmouth (Portsmouth, VA) and National Naval Medical Center (Bethesda, MD). The study protocol was approved by the Clinical Investigation and Review Department of each participating hospital prior to patient enrollment. In March 1998, the Food and Drug Administration (FDA) granted an investigational new drug application for off-label usage of misoprostol. All subjects were thoroughly

Results

Among the 60 enrolled patients, 27 (45%) received misoprostol and 33 (55%) received placebo. No patient disenrolled once entering the study and all patients returned for scheduled follow-up visits and medication administration as described in the study protocol. Of the 45 patients requiring two doses, 37 (82.2%) patients had the same examiner assigning the Bishop score.

As listed in Table 1, the two groups, at time of enrollment, were similar with respect to maternal age, gravidity, parity, and

Discussion

Using the key words misoprostol, cervical ripening, cervical priming, induction, outpatient, and ambulatory cervical ripening, we performed a MEDLINE search of English-language articles published between 1966 and 1999. No publications were found that described an outpatient protocol for cervical ripening with misoprostol. In our trial, most of the patients who were randomized to daily administration of a single 25 μcg dose of intravaginal misoprostol entered active labor within 48 hours of

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This study was supported by the Chief, Navy Bureau of Medicine and Surgery, Washington, DC, Clinical Investigation Program (grants CIP #98–006 and #B99–005).

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The views expressed in this article are those of the authors and do not reflect the official policy or position of the Department of Defense, Department of the Navy, or the United States Government.

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