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

Neonatal Infection Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02985086
Study type Interventional
Source Hospital de Santa Maria, Portugal
Contact Filipa FV Passos, MD
Phone 00351966634530
Email filipafariavazpassos@gmail.com
Status Recruiting
Phase N/A
Start date July 2013
Completion date July 2018
View Details
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