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

Study Overview
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Brief Summary
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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.

Detailed Description
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In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to group A (immediate induction with antibiotic prophylaxis), group B (immediate induction without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).

Official Title
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The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial

Conditions
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Maternal Infection During Pregnancy (Diagnosis), Neonatal Infection

Intervention / Treatment
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* Drug: Cefoxitin
* Drug: oxytocin/misoprostol


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 and a 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, contraindication to expectant management or to vaginal delivery
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Immediate induction with antibiotic prophylaxis<br>Immediate induction with antibiotic prophylaxis | Drug: Cefoxitin<br> <br> Drug: oxytocin/misoprostol<br> <br> |
| Active Comparator: Immediate induction without antibiotic prophylaxis<br>Immediate induction without antibiotic prophylaxis | Drug: oxytocin/misoprostol<br> <br> |
| Active Comparator: Delayed induction with antibiotic prophylaxis<br>Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis | Drug: Cefoxitin<br> <br> Drug: oxytocin/misoprostol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal and neonatal infection rate |  | intrapartum and immediate postpartum | 

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