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

Perineal Lacerations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895973
• Other study ID #: 072008-053
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: January 2010

Study information

• Verified date: November 2018
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lacerations
• Perineal Lacerations

Intervention

Other:
• Stirrups delivery vs bed delivery
Position of legs at time of vaginal delivery (bed vs stirrups)

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any perineal laceration (first through fourth degree)		Immediately post delivery
Secondary	Third and fourth-degree perineal lacerations		Immediately post delivery