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A Randomized, Control Trial for Preinduction Cervical Ripening

A Randomized, Control Trial for Preinduction Cervical Ripening

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00393731
Enrollment
540
Registered
2006-10-30
Start date
2004-01-31
Completion date
2007-08-31
Last updated
2008-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor, Induced

Keywords

labor, induction, misoprostol, oxytocin

Brief summary

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.

Interventions

DRUGMisoprostol
DRUGoxytocin

Sponsors

The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
FEMALE

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

Design outcomes

Primary

MeasureTime frame
Vaginal Delivery rates

Secondary

MeasureTime frame
Time interval to delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026