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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Induction of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Oxytocin

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

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

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

Misoprostol

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

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

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

Interventions

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Oxytocin

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

Intervention Type DRUG

Misoprostol

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

Intervention Type DRUG

Other Intervention Names

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pitocin cytotec

Eligibility Criteria

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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