Oral Misoprostol for Labor Augmentation: A Pilot Study

University of Texas Southwestern Medical Center46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arrest of Dilation in Labor

Interventions

MisoprostolDRUG

Oral misoprostol

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

uterine hyperstimulation

Secondary Outcomes

adequate uterine activity

need for oxytocin augmentation

time from administration of study drug to delivery

route of delivery and indications

maternal and neonatal infectious morbidity

neonatal outcomes

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.