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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00895973
Enrollment
214
Registered
2009-05-11
Start date
2009-03-31
Completion date
2010-01-31
Last updated
2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal Lacerations

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.

Interventions

OTHERStirrups delivery vs bed delivery

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

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Any perineal laceration (first through fourth degree)Immediately post delivery

Secondary

MeasureTime frame
Third and fourth-degree perineal lacerationsImmediately post delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026