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 ]

rate of maternal and neonatal infection between prompt (<12h) and delayed induction (≥12h) in the group of patients not submitted to antibiotic prophylaxis


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