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

Not Applicable

Completed

• Conditions: Perineal Lacerations
• Interventions: Other: Stirrups delivery vs bed delivery

• Registration Number: NCT00895973
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-08
• Study First Posted: 2009-05-11
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-15
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bed delivery	Stirrups delivery vs bed delivery	Mom will be assigned to deliver with the legs positioned in bed in the supine position
Stirrups delivery	Stirrups delivery vs bed delivery	Mom will be assigned to deliver with legs positioned in stirrups

Primary Outcome Measures

Name	Time	Method
Any perineal laceration (first through fourth degree)	Immediately post delivery

Secondary Outcome Measures

Name	Time	Method
Third and fourth-degree perineal lacerations	Immediately post delivery

Trial Locations

Locations (1)

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States