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Completed

NCT Number: NCT01139801

Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.

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Key information

Conditions

Induction of Labor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aultman Health Foundation

Canton, Ohio, 44710, United States

About this study

The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participant or surrogate is capable of giving informed consent
  • Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
  • Participant is undergoing an indicated induction of labor
  • Participant is found to have cervical Bishop score ≤5 on initial cervical exam
  • Participant has no medical or obstetrical contraindications to induction of labor

Exclusion criteria

  • Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
  • Manufacturer's contraindications to misoprostol or oxytocin

Treatment and study plan

Oxytocin

Drug

Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.

Other names: pitocin

Misoprostol

Drug

Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement

Other names: cytotec

Primary outcomes

  1. Rate of Induction To Delivery

    Time frame: 24 hrs

    To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times

Secondary outcomes

  1. Delivery Route

    Time frame: 24 hrs

    To assess for differences in delivery routes

Sponsors and collaborators

Lead sponsor

Aultman Health Foundation

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 9, 2010
Registry last updated
Aug 24, 2018

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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