Clinical Trial: A Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations

Brief Summary: The investigators hypothesize that the rate of perineal lacerations in nulliparous women will be reduced by a simple change in common obstetrical delivery practice, i.e., bed delivery versus conventional delivery in obstetrical stirrups.

Detailed Summary: This is a randomized controlled trial of bed delivery in the supine position versus conventional delivery in obstetrical stirrups. It will include nulliparous women presenting in active labor to the L&D East (low risk) Unit at Parkland Hospital, > 370/7 weeks gestation, with singleton fetuses in cephalic presentation. The primary outcome variable is any perineal laceration. Secondary outcomes measures include (1) 3rd or 4th degree lacerations and (2) any lacerations in subgroup comparisons between study arms.
Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: Any perineal laceration (first through fourth degree) [ Time Frame: Immediately post delivery ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Third and fourth-degree perineal lacerations [ Time Frame: Immediately post delivery ]

Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: May 8, 2009
Date Started: March 2009
Date Completion: January 2010
Last Updated: May 8, 2009
Last Verified: May 2009