Back to resultsA Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
Primary Purpose
Perineal Lacerations
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stirrups delivery vs bed delivery
Sponsored by
About this trial
This is an interventional prevention trial for Perineal Lacerations
Eligibility 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
Sites / Locations
- Parkland Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Stirrups delivery
Bed delivery
Arm Description
Mom will be assigned to deliver with legs positioned in stirrups
Mom will be assigned to deliver with the legs positioned in bed in the supine position
Outcomes
Primary Outcome Measures
Any perineal laceration (first through fourth degree)
Secondary Outcome Measures
Third and fourth-degree perineal lacerations
Full Information
NCT ID
NCT00895973
First Posted
May 8, 2009
Last Updated
November 15, 2018
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00895973
Brief Title
A Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
Official Title
A Randomized Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perineal Lacerations
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stirrups delivery
Arm Type
Experimental
Arm Description
Mom will be assigned to deliver with legs positioned in stirrups
Arm Title
Bed delivery
Arm Type
Experimental
Arm Description
Mom will be assigned to deliver with the legs positioned in bed in the supine position
Intervention Type
Other
Intervention Name(s)
Stirrups delivery vs bed delivery
Intervention Description
Position of legs at time of vaginal delivery (bed vs stirrups)
Primary Outcome Measure Information:
Title
Any perineal laceration (first through fourth degree)
Time Frame
Immediately post delivery
Secondary Outcome Measure Information:
Title
Third and fourth-degree perineal lacerations
Time Frame
Immediately post delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene M Corton, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial of Bed Versus Stirrups Delivery in Nulliparous Women for Prevention of Perineal Lacerations
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