Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

Hospital de Santa Maria, Portugal

Status and phase

Completed

Phase 3

Phase 2

Conditions

Chorioamnionitis

Puerperal Endometritis

Neonatal Meningitis

Neonatal Pneumonia

Neonatal Early Onset Sepsis

Treatments

Drug: Ampicillin + gentamicin

Study type

Interventional

Funder types

Other

Identifiers

NCT01633294

335/08 - 28/07/08

Details and patient eligibility

About

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.

Enrollment

161 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

term (≥ 37+0 weeks) singleton pregnancy
a vertex presentation
ruptured membranes for less than 12 hours
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 (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)
contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery