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Completed

NCT Number: NCT00393731

A Randomized, Control Trial for Preinduction Cervical Ripening

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Lyndon B. Johnson Hospital

Houston, Texas, 77026, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Oxytocin

Drug

Primary outcomes

  1. Vaginal Delivery rates

Secondary outcomes

  1. Time interval to delivery

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Oct 30, 2006
Registry last updated
Jan 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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