Clinical Trial: Safety and Efficacy Study of Intentional Delivery in Women With Preterm and Prelabour Rupture of the Membranes

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Effects of Intentional Delivery After Preterm and Prelabor Rupture of Membranes Between 32 and 35 Weeks of Gestation: A Multicentre Randomized and Controlled Trial

Brief Summary:

Two-year multicentre randomized controlled parallel trial to compare intentional delivery and conservative management in pregnant women with preterm and prelabour rupture of membranes between 32 and 35 weeks.

The purpose of this study is to determine whether intentional delivery of women with PPROM between 32 and 35 week's gestation can decrease the overall neonatal morbidity associated with PPROM-related complications without increasing the morbidity associated with a shortened pregnancy.


Detailed Summary:
Sponsor: University of Alberta

Current Primary Outcome: Length of Stay in hospital [ Time Frame: time between birth and readiness for discharge ]

Original Primary Outcome: NICU Length of Stay (duration between birth and "readiness for discharge")

Current Secondary Outcome:

  • MAIN Score (Morbidity Assessment Index for Newborns) [ Time Frame: From birth to discharge ]
  • Early Onset Neonatal Sepsis [ Time Frame: from birth to discharge ]
  • Clinical and Histological Chorioamnionitis [ Time Frame: from birth to discharge ]
  • Antepartum Length of stay [ Time Frame: From diagnosis to delivery ]
  • C-Section [ Time Frame: delivery ]


Original Secondary Outcome:

  • Main secondary outcomes are:
  • - MAIN Score (Morbidity Assessment Index for Newborns)
  • - Early Onset Neonatal Sepsis
  • - Clinical and Histological Chorioamnionitis
  • - Antepartum Length of stay
  • - C-Section


Information By: University of Alberta

Dates:
Date Received: November 25, 2005
Date Started: January 2006
Date Completion: September 2011
Last Updated: April 5, 2010
Last Verified: April 2010