Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

November 24, 2016 updated by: Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal

Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial

The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.

Study Overview

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 2
  • Phase 3

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

      • Lisboa, Portugal, 1649-035
        • Hospital Santa Maria

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • term (≥ 37+0 weeks) singleton pregnancy
  • a vertex presentation
  • ruptured membranes for less than 12 hours
  • 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 (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)
  • contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) 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
NO_INTERVENTION: Control group
ACTIVE_COMPARATOR: Antibiotic group
women submitted to antibiotic prophylaxis
ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal infection rate
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
neonatal infection rate includes early onset sepsis, meningitis and pneumonia
participants will be followed for the duration of hospital stay, an expected average of 3 days
maternal infection rate
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
maternal infection rate includes chorioamnionitis or puerperal endometritis
participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of the infection rates between prompt and delayed induction
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
rate of maternal and neonatal infection between prompt (<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis
participants will be followed for the duration of hospital stay, an expected average of 3 days

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Filipa Faria Vaz Passos, Dr, Santa Maria Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

October 1, 2008

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2012

Study Registration Dates

First Submitted

June 23, 2012

First Submitted That Met QC Criteria

June 30, 2012

First Posted (ESTIMATE)

July 4, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 28, 2016

Last Update Submitted That Met QC Criteria

November 24, 2016

Last Verified

November 1, 2016

More Information

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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