A Randomized, Control Trial for Preinduction Cervical Ripening

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Labor, Induced

Treatments: Drug: Misoprostol; Drug: oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT00393731

HSC-MS-04-008

Details and patient eligibility

About

The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.

Enrollment: 540 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women that are hospitalized for induction of labor that have a Bishop's score <5
• singleton gestation
• cephalic presentation
• 24 weeks gestational age

Exclusion criteria

• Prior uterine surgery
• malpresentation
• placenta previa or abruption
• clinically suspected or diagnosed intra amniotic infection
• genital HSV infection
• multiple gestation
• premature rupture of the membranes
• active labor
• maternal/fetal conditions that may preclude labor induction in the opinion of the investigators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind