drugset / Trial / NCT01633294

Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

NCT01633294

Phase 2/3 Completed 161 enrolled Hospital de Santa Maria, Portugal
RandomizedParallel-groupOpen-labelPrevention

Summary

The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (\< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.

Timeline

Start
2008-10
Primary completion
2011-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ampicillin Unknown 1 g Intravenous
Comparator Gentamicin Small molecule 240 mg Intravenous