Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-07-31

Brief Summary

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The primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with PROM later than the 37+0 weeks of gestation. The secondary aim is to compare the rates of infection between immediate and delayed induction in women submitted to antibiotic prophylaxis.

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Detailed Description

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In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to group A (immediate induction with antibiotic prophylaxis), group B (immediate induction without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).

Conditions

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Maternal Infection During Pregnancy (Diagnosis) Neonatal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immediate induction with antibiotic prophylaxis

Group Type ACTIVE_COMPARATOR

Cefoxitin

Intervention Type DRUG

oxytocin/misoprostol

Intervention Type DRUG

Immediate induction without antibiotic prophylaxis

Group Type ACTIVE_COMPARATOR

oxytocin/misoprostol

Intervention Type DRUG

Delayed induction with antibiotic prophylaxis

Delayed induction (\>= 12 hours after PROM) with antibiotic prophylaxis

Group Type ACTIVE_COMPARATOR

Cefoxitin

Intervention Type DRUG

oxytocin/misoprostol

Intervention Type DRUG

Interventions

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Cefoxitin

Intervention Type DRUG

oxytocin/misoprostol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* term (≥ 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes for less than 12 hours and a negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks.