Oral Misoprostol for Labor Augmentation: A Pilot Study

• Sponsor: University of Texas Southwestern Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00906126
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 5
• Duration (Months): 25
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrest of Dilation in Labor	Drug: Misoprostol	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Oral Misoprostol for Labor Augmentation: A Dose-Finding Pilot Study
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oral Misoprostol 1 Oral misoprostol 25 micrograms every 4 hours for up to two doses.	Drug: Misoprostol; Oral misoprostol; Other Names: Cytotec
Experimental: Oral Misoprostol 2 Oral misoprostol 50 micrograms every 4 hours for up to two doses.	Drug: Misoprostol; Oral misoprostol; Other Names: Cytotec
Experimental: Oral Misoprostol 3 Oral misoprostol 100 micrograms every 4 hours for up to two doses.	Drug: Misoprostol; Oral misoprostol; Other Names: Cytotec
Experimental: Oral Misoprostol 4 Oral Misoprostol 50 micrograms every 2 hours for up to two doses.	Drug: Misoprostol; Oral misoprostol; Other Names: Cytotec
Experimental: Oral Misoprostol 5 Oral Misoprostol 75 micrograms every 4 hours for up to two doses.	Drug: Misoprostol; Oral misoprostol; Other Names: Cytotec

Outcome Measures

Primary Outcome Measures

1. uterine hyperstimulation []

Secondary Outcome Measures

1. adequate uterine activity []

2. need for oxytocin augmentation []

3. time from administration of study drug to delivery []

4. route of delivery and indications []

5. maternal and neonatal infectious morbidity []

6. neonatal outcomes []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

• University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Kathryn S Villano, M.D., University of Texas Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00906126
• Other Study ID Numbers: 122006051
• First Posted: May 21, 2009
• Last Update Posted: May 21, 2009
• Last Verified: May 1, 2009

• Keywords provided by , ,: oral misoprostol; labor augmentation; arrest of dilation; nulliparous
• Additional relevant MeSH terms: Dilatation, Pathologic; Misoprostol

Study Results

No Results Posted as of May 21, 2009