Oral Misoprostol for Labor Augmentation: A Pilot Study

Completed · Phase 1

Conditions studied: Arrest of Dilation in Labor

In brief

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.

Key facts

Study ID

NCT00906126

Run by

University of Texas Southwestern Medical Center

People needed

46

Starts

2007-04-01

Expected to finish

2009-05-01

Last updated by the study team

2009-05-21

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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