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

Sponsor

Hospital de Santa Maria, Portugal (Other)

Overall Status

Unknown status

CT.gov ID

NCT02985086

Collaborator

(none)

568

Enrollment

Locations

Arms

Duration (Months)

284

Patients Per Site

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Infection During Pregnancy (Diagnosis) Neonatal Infection	Drug: Cefoxitin Drug: oxytocin/misoprostol	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

568 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Immediate induction with antibiotic prophylaxis Immediate induction with antibiotic prophylaxis	Drug: Cefoxitin Drug: oxytocin/misoprostol
Active Comparator: Immediate induction without antibiotic prophylaxis Immediate induction without antibiotic prophylaxis	Drug: oxytocin/misoprostol
Active Comparator: Delayed induction with antibiotic prophylaxis Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis	Drug: Cefoxitin Drug: oxytocin/misoprostol

Arm

Intervention/Treatment

Active Comparator: Immediate induction with antibiotic prophylaxis

Immediate induction with antibiotic prophylaxis

Drug: Cefoxitin

Drug: oxytocin/misoprostol

Active Comparator: Immediate induction without antibiotic prophylaxis

Immediate induction without antibiotic prophylaxis

Drug: oxytocin/misoprostol

Active Comparator: Delayed induction with antibiotic prophylaxis

Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis

Drug: Cefoxitin

Drug: oxytocin/misoprostol

Outcome Measures

Primary Outcome Measures

Maternal and neonatal infection rate [intrapartum and immediate postpartum]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.