A dose-finding study of oral misoprostol for labor augmentation

Kathryn S. Villano, Julie Y. Lo, James M. Alexander, Donald D. McIntire, Kenneth J. Leveno

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


Objective: We designed a dose-finding trial of oral misoprostol administered for labor augmentation. Study Design: Healthy, nulliparous women in active labor and diagnosed with arrest of dilation were enrolled in cohorts of 10 at a time. Five regimens were studied: (1) 25 μg every 4 hours, (2) 50 μg every 4 hours, (3) 100 μg every 4 hours, (4) 50 μg every 2 hours, and (5) 75 μg every 4 hours. Results: A total of 46 women were enrolled. Baseline uterine activity approximately doubled with 4 of the regimens and tripled with the highest dosage regimen (100 μg) (P < .001). The 100-μg regimen was truncated due to excessive uterine hyperstimulation (40%). Conclusion: An oral dose of 75 μg of misoprostol given at a 4-hour interval for a maximum of 2 doses is the highest tolerated dose. Randomized, controlled trials will be required before a regimen is employed routinely.

Original languageEnglish (US)
Pages (from-to)560.e1-560.e5
JournalAmerican journal of obstetrics and gynecology
Issue number6
StatePublished - Jun 2011


  • dose-finding
  • labor augmentation
  • oral misoprostol
  • phase I trial

ASJC Scopus subject areas

  • Obstetrics and Gynecology


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