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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Texas Southwestern Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00895973
First received: May 8, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Perineal Lacerations
Other: Stirrups delivery vs bed delivery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Any perineal laceration (first through fourth degree) [ Time Frame: Immediately post delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Third and fourth-degree perineal lacerations [ Time Frame: Immediately post delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 194
Study Start Date: March 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stirrups delivery
Mom will be assigned to deliver with legs positioned in stirrups
Other: Stirrups delivery vs bed delivery
Position of legs at time of vaginal delivery (bed vs stirrups)
Experimental: Bed delivery
Mom will be assigned to deliver with the legs positioned in bed in the supine position
Other: Stirrups delivery vs bed delivery
Position of legs at time of vaginal delivery (bed vs stirrups)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nulliparous women presenting in active labor to Parkland L&D East Unit
  • ≥ 370/7 weeks gestation
  • Singleton fetus in cephalic presentation
  • ≥ 4 cm but ≤ 8 cm of cervical dilation
  • No medical or obstetrical complication

Exclusion Criteria:

  • Women with any obstetric or medical complication of pregnancy, such as pregnancy related hypertension, diabetes, labor induction
  • Prior history of perineal trauma requiring surgical repair or known congenital perineal malformation
  • Non-English or non-Spanish speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895973

Locations
United States, Texas
Parkland Memorial Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: Marlene M Corton, M.D.    214-648-6430    marlene.corton@utsouthwestern.edu   
Principal Investigator: Marlene M Corton, M.D.         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Marlene M Corton, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Marlene M. Corton, Associate Professor of Obstetrics and Gynecology, UT Southwestern Medical Center, Dallas, Texas
ClinicalTrials.gov Identifier: NCT00895973     History of Changes
Other Study ID Numbers: 072008-053
Study First Received: May 8, 2009
Last Updated: May 8, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries

ClinicalTrials.gov processed this record on July 23, 2014