Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Santa Maria, Portugal
• Treatments: Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Gentamicins

Criteria

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