Skip to main content
OpenTrials
Completed

NCT Number: NCT00895973

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Perineal Lacerations

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stirrups delivery vs bed delivery

Other

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

Primary outcomes

  1. Any perineal laceration (first through fourth degree)

    Time frame: Immediately post delivery

Secondary outcomes

  1. Third and fourth-degree perineal lacerations

    Time frame: Immediately post delivery

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 11, 2009
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.