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The Patient Positioning for Perineal Protection Study

NCT04616170 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1206

Last updated 2025-07-17

No results posted yet for this study

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

Interventions

OTHER

Hip extension

Hips extended at the time of vaginal delivery

OTHER

Usual Care

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Marti D Soffer, MD MPH · Massachusetts General Hospital

  • William H Barth, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-05
Primary Completion
2025-07-11
Completion
2025-07-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04616170 on ClinicalTrials.gov