Oral Misoprostol for Labor Augmentation: A Pilot Study

Phase 1

Completed

• Conditions: Arrest of Dilation in Labor
• Interventions: Drug: Misoprostol

• Registration Number: NCT00906126
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2008-09
• Status Verified: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-20
• Last Update Submitted: 2009-05-20
• Study First Posted: 2009-05-21
• Last Update Posted: 2009-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral Misoprostol 2	Misoprostol	Oral misoprostol 50 micrograms every 4 hours for up to two doses.
Oral Misoprostol 1	Misoprostol	Oral misoprostol 25 micrograms every 4 hours for up to two doses.
Oral Misoprostol 4	Misoprostol	Oral Misoprostol 50 micrograms every 2 hours for up to two doses.
Oral Misoprostol 3	Misoprostol	Oral misoprostol 100 micrograms every 4 hours for up to two doses.
Oral Misoprostol 5	Misoprostol	Oral Misoprostol 75 micrograms every 4 hours for up to two doses.

Primary Outcome Measures

Name	Time	Method
uterine hyperstimulation

Secondary Outcome Measures

Name	Time	Method
need for oxytocin augmentation
adequate uterine activity
time from administration of study drug to delivery
route of delivery and indications
maternal and neonatal infectious morbidity
neonatal outcomes

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States