NCT02985086

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 568 (estimated)
• Sponsor: Hospital de Santa Maria, Portugal · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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).

Conditions

• Maternal Infection During Pregnancy (Diagnosis)
• Neonatal Infection

Interventions

Type	Name	Description
DRUG	Cefoxitin
DRUG	oxytocin/misoprostol

Timeline

• Start date: 2013-07-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2016-12-07
• Last updated: 2016-12-13

Locations

2 sites across 1 country: Portugal