The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Cefoxitin
- Conditions
- Maternal Infection During Pregnancy (Diagnosis)
- Sponsor
- Hospital de Santa Maria, Portugal
- Enrollment
- 568
- Locations
- 2
- Primary Endpoint
- Maternal and neonatal infection rate
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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).
Investigators
Filipa Faria Vaz Passos
Principal Investigator
Hospital de Santa Maria, Portugal
Eligibility Criteria
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
Arms & Interventions
Immediate induction with antibiotic prophylaxis
Immediate induction with antibiotic prophylaxis
Intervention: Cefoxitin
Immediate induction with antibiotic prophylaxis
Immediate induction with antibiotic prophylaxis
Intervention: oxytocin/misoprostol
Immediate induction without antibiotic prophylaxis
Immediate induction without antibiotic prophylaxis
Intervention: oxytocin/misoprostol
Delayed induction with antibiotic prophylaxis
Delayed induction (\>= 12 hours after PROM) with antibiotic prophylaxis
Intervention: Cefoxitin
Delayed induction with antibiotic prophylaxis
Delayed induction (\>= 12 hours after PROM) with antibiotic prophylaxis
Intervention: oxytocin/misoprostol
Outcomes
Primary Outcomes
Maternal and neonatal infection rate
Time Frame: intrapartum and immediate postpartum