Clinical Trial: Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial
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 Summary:
Sponsor: Hospital de Santa Maria, Portugal
Current Primary Outcome:
- neonatal infection rate [ Time Frame: 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 [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]maternal infection rate includes chorioamnionitis or puerperal endometritis
Original Primary Outcome: Same as current
Current Secondary Outcome: comparison of the infection rates between prompt and delayed induction [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]
Original Secondary Outcome: Same as current
Information By: Hospital de Santa Maria, Portugal
Dates:
Date Received: June 23, 2012
Date Started: October 2008
Date Completion:
Last Updated: November 24, 2016
Last Verified: November 2016