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

December 10, 2016 updated by: Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal

The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Anticipated)

568

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Almada, Portugal
        • Recruiting
        • Hospital Garcia de Orta, EPE
      • Lisbon, Portugal
        • Recruiting
        • Hospital de Santa Maria, CHLN, EPE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Exclusion Criteria:

  • active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis, contraindication to expectant management or to vaginal delivery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Immediate induction with antibiotic prophylaxis
Drug: Cefoxitin
Drug: oxytocin/misoprostol
ACTIVE_COMPARATOR: Immediate induction without antibiotic prophylaxis
Drug: oxytocin/misoprostol
ACTIVE_COMPARATOR: Delayed induction with antibiotic prophylaxis
Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis
Drug: Cefoxitin
Drug: oxytocin/misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maternal and neonatal infection rate
Time Frame: intrapartum and immediate postpartum
intrapartum and immediate postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Santa Maria, Portugal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ANTICIPATED)

July 1, 2018

Study Completion (ANTICIPATED)

July 1, 2018

Study Registration Dates

First Submitted

December 5, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (ESTIMATE)

December 7, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2016

Last Update Submitted That Met QC Criteria

December 10, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SantaMariaGarciadeOrtaPortugal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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