Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

Study Overview
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Brief Summary
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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.

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

Conditions
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Chorioamnionitis, Puerperal Endometritis, Neonatal Early Onset Sepsis, Neonatal Meningitis, Neonatal Pneumonia

Intervention / Treatment
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* Drug: Ampicillin + gentamicin


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antibiotic group<br>women submitted to antibiotic prophylaxis | Drug: Ampicillin + gentamicin<br>* ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal infection rate | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature rupture of membranes, term pregnancy, chorioamnionitis, endometritis, neonatal sepsis, antibiotic prophylaxis