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

Study Overview
=================
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.

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

Conditions
-----------------
Perineal Lacerations

Intervention / Treatment
-----------------
* Other: Stirrups delivery vs bed delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stirrups delivery<br>Mom will be assigned to deliver with legs positioned in stirrups | Other: Stirrups delivery vs bed delivery<br>* Position of legs at time of vaginal delivery (bed vs stirrups)<br>|
| Experimental: Bed delivery<br>Mom will be assigned to deliver with the legs positioned in bed in the supine position | Other: Stirrups delivery vs bed delivery<br>* Position of legs at time of vaginal delivery (bed vs stirrups)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any perineal laceration (first through fourth degree) |  | Immediately post delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Third and fourth-degree perineal lacerations |  | Immediately post delivery |