Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-10-31

Brief Summary

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The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.

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Detailed Description

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This is a prospective, randomized trial that aims to enroll 200 singleton pregnancies presenting for preinduction ripening. Patients will be randomized to receive either TFC alone (control) or TFC plus low-dose oxytocin (treatment). Providers will not blinded to use of oxytocin and labor was managed according to routine obstetric protocols. This study is powered to detect a 20% difference in the proportion of patients delivered within 24 hours, the primary outcome. Secondary outcomes are related to vaginal delivery rate, duration of induction, complications, and pain management.

Conditions

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Pregnancy Induced Labor Cervical Ripening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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low dose oxytocin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* singleton gestation
* presenting for induction as determined by their primary obstetrical provider
* with fetuses in cephalic presentation
* gestational age greater than 23 weeks

Exclusion Criteria

* any condition precluding vaginal delivery
* estimated fetal weight \>4500 grams
* a previous attempt at ripening or induction during the pregnancy
* clinically significant cervical or vaginal infection
* chorioamnionitis
* HIV
* hepatitis B or C
* unexplained vaginal bleeding
* low-lying placenta
* abnormal cervical anatomy or cervical cerclage
* latex allergy

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No