CompletedPhase 2/3

Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term

Portugal161 participantsStarted 2008-10

Plain-language 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.

Who can participate

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

neonatal infection rate

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days

maternal infection rate

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 3 days

Trial details

NCT IDNCT01633294

SponsorHospital de Santa Maria, Portugal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-01

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