The Patient Positioning for Perineal Protection Study (4P)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Perineal Tear; Delivery; Trauma; Perineal Laceration
• Intervention / Treatment: Other: Usual Care; Other: Hip extension

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; 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.	Other: Usual Care; Hips positioned in the "usual care" position per provider preference at the time of vaginal delivery
Experimental: Hip extension; Patients in this arm will be randomized to hip extension at the time of crowning of the fetal vertex during vaginal delivery.	Other: Hip extension; Hips extended at the time of vaginal delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification of perineal laceration	The degree of perineal laceration as classified by the American College of Obstetricians and Gynecologists (ACOG) classification system	At the time of vaginal delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of OASIS laceration	Number of obstetric anal sphincter injury lacerations compared to all deliveries	At the time of vaginal delivery

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Study Director: Marti D Soffer, MD MPH, Massachusetts General Hospital; Principal Investigator: William H Barth, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 30, 2020
• First Posted (Actual): November 4, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 18, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: perineal tear; vaginal delivery; perineal laceration; delivery position
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: 2020P003603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No