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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Perineal Lacerations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Stirrups delivery

Mom will be assigned to deliver with legs positioned in stirrups

Group Type EXPERIMENTAL

Stirrups delivery vs bed delivery

Intervention Type OTHER

Position of legs at time of vaginal delivery (bed vs stirrups)

Bed delivery

Mom will be assigned to deliver with the legs positioned in bed in the supine position

Group Type EXPERIMENTAL

Stirrups delivery vs bed delivery

Intervention Type OTHER

Position of legs at time of vaginal delivery (bed vs stirrups)

Interventions

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Stirrups delivery vs bed delivery

Position of legs at time of vaginal delivery (bed vs stirrups)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes