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Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Filipa Faria Vaz Passos, Hospital de Santa Maria, Portugal
ClinicalTrials.gov Identifier:
NCT01633294
First received: June 23, 2012
Last updated: June 30, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chorioamnionitis
Puerperal Endometritis
Neonatal Early Onset Sepsis
Neonatal Meningitis
Neonatal Pneumonia
 Drug: Ampicillin + gentamicin
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital de Santa Maria, Portugal:

Primary Outcome Measures:
  • neonatal infection rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    neonatal infection rate includes early onset sepsis, meningitis and pneumonia

  • maternal infection rate [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    maternal infection rate includes chorioamnionitis or puerperal endometritis


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    rate of maternal and neonatal infection between prompt (<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis


Enrollment: 161
Study Start Date: October 2008
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antibiotic group
women submitted to antibiotic prophylaxis
 Drug: Ampicillin + gentamicin
ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously
No Intervention: Control group

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633294

Locations
Portugal
Hospital Santa Maria
Lisboa, Portugal, 1649-035
Sponsors and Collaborators
Hospital de Santa Maria, Portugal
Investigators
Principal Investigator: Filipa Faria Vaz Passos, Dr Santa Maria Hospital
  More Information

No publications provided by Hospital de Santa Maria, Portugal

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Filipa Faria Vaz Passos, Principal investigator, Hospital de Santa Maria, Portugal
ClinicalTrials.gov Identifier: NCT01633294     History of Changes
Other Study ID Numbers: 335/08 - 28/07/08
Study First Received: June 23, 2012
Last Updated: June 30, 2012
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Hospital de Santa Maria, Portugal:
premature rupture of membranes
term pregnancy
chorioamnionitis
 endometritis
neonatal sepsis
antibiotic prophylaxis

Additional relevant MeSH terms:
Chorioamnionitis
Endometritis
Meningitis
Pneumonia
Sepsis
Rupture
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
 Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Wounds and Injuries
Ampicillin
Anti-Bacterial Agents
Gentamicins
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 16, 2013