Outpatient cervical ripening with intravaginal misoprostol1☆,
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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Cited by (0)
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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.