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Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

NCT01633294 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2016-11-28

No results posted yet for this study

Summary

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.

Conditions

  • Chorioamnionitis
  • Puerperal Endometritis
  • Neonatal Early Onset Sepsis
  • Neonatal Meningitis
  • Neonatal Pneumonia

Interventions

DRUG

Ampicillin + gentamicin

ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously

Sponsors & Collaborators

  • Hospital de Santa Maria, Portugal

    lead OTHER

Principal Investigators

  • Filipa Faria Vaz Passos, Dr · Santa Maria Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-01-31
Completion
2012-01-31

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 NCT01633294 on ClinicalTrials.gov