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

Not Applicable

• Conditions: Maternal Infection During Pregnancy (Diagnosis); Neonatal Infection
• Interventions: Drug: Cefoxitin; Drug: oxytocin/misoprostol

• Registration Number: NCT02985086
• Lead Sponsor: Hospital de Santa Maria, Portugal

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).

Study Timeline

• Study Start: 2013-07
• Status Verified: 2016-12
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-07
• Last Update Submitted: 2016-12-10
• Last Update Posted: 2016-12-13
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 568

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate induction with antibiotic prophylaxis	oxytocin/misoprostol	Immediate induction with antibiotic prophylaxis
Immediate induction without antibiotic prophylaxis	oxytocin/misoprostol	Immediate induction without antibiotic prophylaxis
Delayed induction with antibiotic prophylaxis	oxytocin/misoprostol	Delayed induction (\>= 12 hours after PROM) with antibiotic prophylaxis
Immediate induction with antibiotic prophylaxis	Cefoxitin	Immediate induction with antibiotic prophylaxis
Delayed induction with antibiotic prophylaxis	Cefoxitin	Delayed induction (\>= 12 hours after PROM) with antibiotic prophylaxis

Primary Outcome Measures

Name	Time	Method
Maternal and neonatal infection rate	intrapartum and immediate postpartum

Trial Locations

Locations (2)

Hospital Garcia de Orta, EPE; 🇵🇹 Almada, Portugal

Hospital de Santa Maria, CHLN, EPE; 🇵🇹 Lisbon, Portugal