Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

Phase 2

Completed

• Conditions: Puerperal Endometritis; Neonatal Meningitis; Chorioamnionitis; Neonatal Early Onset Sepsis; Neonatal Pneumonia
• Interventions: Drug: Ampicillin + gentamicin

• Registration Number: NCT01633294
• Lead Sponsor: Hospital de Santa Maria, Portugal

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2011-01
• Study Completion: 2012-01
• Study First Submitted: 2012-06-23
• Study First Submitted QC: 2012-06-30
• Study First Posted: 2012-07-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-24
• Last Update Posted: 2016-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic group	Ampicillin + gentamicin	women submitted to antibiotic prophylaxis

Primary Outcome Measures

Name	Time	Method
neonatal infection rate	participants will be followed for the duration of hospital stay, an expected average of 3 days	neonatal infection rate includes early onset sepsis, meningitis and pneumonia
maternal infection rate	participants will be followed for the duration of hospital stay, an expected average of 3 days	maternal infection rate includes chorioamnionitis or puerperal endometritis

Secondary Outcome Measures

Name	Time	Method
comparison of the infection rates between prompt and delayed induction	participants will be followed for the duration of hospital stay, an expected average of 3 days	rate of maternal and neonatal infection between prompt (\<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis

Trial Locations

Locations (1)

Hospital Santa Maria; 🇵🇹 Lisboa, Portugal