CompletedPhase 1

Oral Misoprostol for Labor Augmentation: A Pilot Study

United States46 participantsStarted 2007-04

Plain-language summary

A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * nulliparous * gestational age of at least 36 weeks * singleton gestation * cephalic presentation * reassuring fetal heart rate * 4 cm or greater cervical dilation * ruptured membranes with clear amnionic fluid * intrauterine pressure catheter in place * less than 200 MVU's Exclusion Criteria: * non-reassuring fetal heart rate * meconium-stained amnionic fluid * previous uterine incision * maternal fever * pregnancy-induced hypertension or other pregnancy-related complications * known fetal anomalies * placenta previa or unexplained vaginal bleeding * estimated fetal weight of 4,500 grams or greater * evidence of cephalopelvic disproportion * any moderate or severe preexisting disease * contraindication to the use of prostaglandins

What they're measuring

uterine hyperstimulation

Trial details

NCT IDNCT00906126

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-09

View on ClinicalTrials.gov More Arrest of Dilation in Labor trials