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Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

Primary Purpose

Chorioamnionitis, Puerperal Endometritis, Neonatal Early Onset Sepsis

Status
Completed
Phase
Phase 2
Locations
Portugal
Study Type
Interventional
Intervention
Ampicillin + gentamicin
Sponsored by
Hospital de Santa Maria, Portugal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chorioamnionitis focused on measuring premature rupture of membranes, term pregnancy, chorioamnionitis, endometritis, neonatal sepsis, antibiotic prophylaxis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Santa Maria

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Antibiotic group

Control group

Arm Description

women submitted to antibiotic prophylaxis

Outcomes

Primary Outcome Measures

neonatal infection rate
neonatal infection rate includes early onset sepsis, meningitis and pneumonia
maternal infection rate
maternal infection rate includes chorioamnionitis or puerperal endometritis

Secondary Outcome Measures

comparison of the infection rates between prompt and delayed induction
rate of maternal and neonatal infection between prompt (<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis

Full Information

First Posted
June 23, 2012
Last Updated
November 24, 2016
Sponsor
Hospital de Santa Maria, Portugal
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1. Study Identification

Unique Protocol Identification Number
NCT01633294
Brief Title
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
Official Title
Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Santa Maria, Portugal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chorioamnionitis, Puerperal Endometritis, Neonatal Early Onset Sepsis, Neonatal Meningitis, Neonatal Pneumonia
Keywords
premature rupture of membranes, term pregnancy, chorioamnionitis, endometritis, neonatal sepsis, antibiotic prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic group
Arm Type
Active Comparator
Arm Description
women submitted to antibiotic prophylaxis
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Ampicillin + gentamicin
Intervention Description
ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously
Primary Outcome Measure Information:
Title
neonatal infection rate
Description
neonatal infection rate includes early onset sepsis, meningitis and pneumonia
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 days
Title
maternal infection rate
Description
maternal infection rate includes chorioamnionitis or puerperal endometritis
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary Outcome Measure Information:
Title
comparison of the infection rates between prompt and delayed induction
Description
rate of maternal and neonatal infection between prompt (<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 days

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filipa Faria Vaz Passos, Dr
Organizational Affiliation
Santa Maria Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
23090521
Citation
Passos F, Cardoso K, Coelho AM, Graca A, Clode N, Mendes da Graca L. Antibiotic prophylaxis in premature rupture of membranes at term: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1045-51. doi: 10.1097/aog.0b013e31826e46bc.
Results Reference
derived

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Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

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