A dose-finding study of oral misoprostol for labor augmentation

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 e...

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Bibliographic Details
Published in:American journal of obstetrics and gynecology 2011-06, Vol.204 (6), p.560.e1-560.e5
Main Authors: Villano, Kathryn S., MD, Lo, Julie Y., MD, Alexander, James M., MD, McIntire, Donald D., PhD, Leveno, Kenneth J., MD
Format: Article
Language:English
Subjects:
Administration, Oral
Biological and medical sciences
Delivery. Postpartum. Lactation
Digestive system
dose-finding
Drug Dosage Calculations
Female
Gynecology. Andrology. Obstetrics
Humans
labor augmentation
Medical sciences
Misoprostol - administration & dosage
Obstetrics and Gynecology
oral misoprostol
Oxytocics - administration & dosage
Pharmacology. Drug treatments
phase I trial
Pregnancy
Young Adult
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Summary: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.
ISSN:0002-9378
1097-6868
DOI:10.1016/j.ajog.2011.02.064