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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by University of Texas Southwestern Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00895973
First Posted: May 11, 2009
Last Update Posted: May 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Texas Southwestern Medical Center
  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: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations

Resource links provided by NLM:


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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 8, 2009
First Posted: May 11, 2009
Last Update Posted: May 11, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries