Oral Misoprostol for Labor Augmentation: A Pilot Study

The University of Texas System (UT)

Status and phase: Completed; Phase 1

Conditions: Arrest of Dilation in Labor

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00906126

122006051

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 5 patient groups

Oral Misoprostol 1

Experimental group

Description:

Oral misoprostol 25 micrograms every 4 hours for up to two doses.

Treatment:

Drug: Misoprostol

Oral Misoprostol 2

Experimental group

Description:

Oral misoprostol 50 micrograms every 4 hours for up to two doses.

Treatment:

Drug: Misoprostol

Oral Misoprostol 3

Experimental group

Description:

Oral misoprostol 100 micrograms every 4 hours for up to two doses.

Treatment:

Drug: Misoprostol

Oral Misoprostol 4

Experimental group

Description:

Oral Misoprostol 50 micrograms every 2 hours for up to two doses.

Treatment:

Drug: Misoprostol

Oral Misoprostol 5

Experimental group

Description:

Oral Misoprostol 75 micrograms every 4 hours for up to two doses.

Treatment:

Drug: Misoprostol