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The Patient Positioning for Perineal Protection Study (4P)

Primary Purpose

Perineal Tear, Delivery; Trauma, Perineal Laceration

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hip extension
Usual Care
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perineal Tear focused on measuring perineal tear, perineal laceration, vaginal delivery, delivery position

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Nulliparous women
  • Non-anomalous fetuses
  • Term gestation
  • Vertex presentation
  • Eligible for trial of labor

Exclusion Criteria:

  • Multiparous women
  • Prior perineal malformations
  • History female genital mutilation
  • Prior perineal surgery
  • Anomalous fetuses
  • Multiple gestations
  • Fetal status incompatible with labor

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care

Hip extension

Arm Description

Patients in this arm will be randomized to the routine positioning instructions given at the time of crowning of the fetal vertex during vaginal delivery.

Patients in this arm will be randomized to hip extension at the time of crowning of the fetal vertex during vaginal delivery.

Outcomes

Primary Outcome Measures

Classification of perineal laceration
The degree of perineal laceration as classified by the American College of Obstetricians and Gynecologists (ACOG) classification system

Secondary Outcome Measures

Rate of OASIS laceration
Number of obstetric anal sphincter injury lacerations compared to all deliveries

Full Information

First Posted
October 26, 2020
Last Updated
March 18, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04616170
Brief Title
The Patient Positioning for Perineal Protection Study
Acronym
4P
Official Title
The Patient Positioning for Perineal Protection Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
It is common practice for practitioners to instruct patients to forcibly flex the hips at the time of delivery of the fetal vertex. Though this is commonplace, it is reasonable to assume that this forced stretching of the perineum at the time of fetal vertex emergence could potentially lead to higher rates of severe lacerations and their sequelae. This study will examine whether extending the hips, as compared to usual care, at the time of crowning of the fetal vertex during vaginal delivery decreases maternal perineal trauma among nulliparous women.
Detailed Description
Perineal trauma at the time of vaginal delivery is a significant cause of maternal morbidity including vaginal pain, dyspareunia, urinary incontinence, infection, and social isolation in severe cases. There are well known risk factors in the literature for OASIS (obstetric anal sphincter injuries), however, this literature is by no means comprehensive. A prior RCT in 2012 looked at the role of patient positioning at the time of pushing and delivery to determine whether stirrup positioning and forced hip flexion leads to higher rates of any perineal tears. The study concluded that stirrup positioning did not lead to higher rates of perineal tearing but was not powered to evaluate the role of positioning on OASIS tears or on postpartum perineal morbidity. In addition to lacking data with respect to patient positioning, data is limited regarding perineal morbidity beyond the traditional grading system of 1st, 2nd, 3rd, and 4th degree tears. 3rd and 4th degree lacerations are labeled as OASIS, however, perineal morbidity can result from "lower" orders of perineal tearing at the time of delivery. Prior studies have tried to illustrate various subsets of second degree lacerations in an attempt to subdivide 2nd degree lacerations into categories of severity, however, little has been done in practice with this form of division and little is written on the topic of perineal morbidity beyond OASIS tears. It is common practice for practitioners to instruct patients to flex the hips at the time of delivery of the fetal vertex. Though this is commonplace, it is reasonable to assume that this stretching of the perineum at the time of fetal vertex emergence could potentially lead to higher rates of severe lacerations and their sequelae. The closest studies to examine this have been in comparing women who deliver in the squatting position compared to in lithotomy. Those who deliver in squatting positions have been found to have deeper perineal lacerations, which demonstrate the possibility that forced flexion at the hips could lead to the same outcome in the lithotomy position. Should research show an increased risk of morbidity with this near universal positioning practice as compared to hip extension, this study could change practice patterns for the betterment of patients worldwide.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perineal Tear, Delivery; Trauma, Perineal Laceration
Keywords
perineal tear, perineal laceration, vaginal delivery, delivery position

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be assigned to usual care or hip extension at the time of delivery of the fetal vertex
Masking
Outcomes Assessor
Masking Description
The statistician performing the primary analysis will be blinded to the assignment of the patients
Allocation
Randomized
Enrollment
1206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Patients in this arm will be randomized to the routine positioning instructions given at the time of crowning of the fetal vertex during vaginal delivery.
Arm Title
Hip extension
Arm Type
Experimental
Arm Description
Patients in this arm will be randomized to hip extension at the time of crowning of the fetal vertex during vaginal delivery.
Intervention Type
Other
Intervention Name(s)
Hip extension
Intervention Description
Hips extended at the time of vaginal delivery
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Hips positioned in the "usual care" position per provider preference at the time of vaginal delivery
Primary Outcome Measure Information:
Title
Classification of perineal laceration
Description
The degree of perineal laceration as classified by the American College of Obstetricians and Gynecologists (ACOG) classification system
Time Frame
At the time of vaginal delivery
Secondary Outcome Measure Information:
Title
Rate of OASIS laceration
Description
Number of obstetric anal sphincter injury lacerations compared to all deliveries
Time Frame
At the time of vaginal delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Nulliparous women Non-anomalous fetuses Term gestation Vertex presentation Eligible for trial of labor Exclusion Criteria: Multiparous women Prior perineal malformations History female genital mutilation Prior perineal surgery Anomalous fetuses Multiple gestations Fetal status incompatible with labor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marti D Soffer, MD MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
William H Barth, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Patient Positioning for Perineal Protection Study

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