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

NCT02985086 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2016-12-13

No results posted yet for this study

Summary

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.

Conditions

  • Maternal Infection During Pregnancy (Diagnosis)
  • Neonatal Infection

Interventions

DRUG

Cefoxitin

DRUG

oxytocin/misoprostol

Sponsors & Collaborators

  • Hospital de Santa Maria, Portugal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985086 on ClinicalTrials.gov