The Patient Positioning for Perineal Protection Study

NCT04616170 | Completed DMC

• 1 other identifier: 2020P003603
• Study Type: interventional
• Target: 1,206
• Locations: 1 country
• Sites: 1

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.

Conditions

Perineal Tear; Delivery; Trauma; Perineal Laceration

Keywords

perineal tear; perineal laceration; vaginal delivery; delivery position

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of OASIS laceration

  At the time of vaginal delivery

Study Arms (2)

Usual care

ACTIVE COMPARATOR

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

Hip extension

EXPERIMENTAL

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

Interventions

Hip extension OTHER

Hips extended at the time of vaginal delivery

Hip extension

Usual Care OTHER

Hips positioned in the "usual care" position per provider preference at the time of vaginal delivery

Usual care

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Marti D Soffer, MD MPH

  Massachusetts General Hospital

  STUDY DIRECTOR

• William H Barth, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician performing the primary analysis will be blinded to the assignment of the patients
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Obstetrics (Chief of Obstetrics)

Model Details: Patients will be assigned to usual care or hip extension at the time of delivery of the fetal vertex

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 4, 2020
• Study Start: April 5, 2021
• Primary Completion: July 11, 2025
• Study Completion: July 11, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)