NCT00895973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 11, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

May 8, 2009

Last Update Submit

November 15, 2018

Conditions

Perineal Lacerations

Outcome Measures

Primary Outcomes (1)

  • Any perineal laceration (first through fourth degree)

    Immediately post delivery

Secondary Outcomes (1)

  • Third and fourth-degree perineal lacerations

    Immediately post delivery

Study Arms (2)

Stirrups delivery

EXPERIMENTAL

Mom will be assigned to deliver with legs positioned in stirrups

Other: Stirrups delivery vs bed delivery

Bed delivery

EXPERIMENTAL

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

Other: Stirrups delivery vs bed delivery

Interventions

Stirrups delivery vs bed deliveryOTHER

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

Bed deliveryStirrups delivery

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

Study Officials

  • Marlene M Corton, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 8, 2009

First Posted

May 11, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

November 19, 2018

Record last verified: 2018-11

Locations

US(1)