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NCT04616170 · ClinicalTrials.gov registry record · NA

The Patient Positioning for Perineal Protection Study

A NA study, sponsored by Massachusetts General Hospital.

Completed
Registry status
NA
Development phase
1,206
Enrollment target

NCT04616170: Completed NA study, sponsored by Massachusetts General Hospital.

NCT04616170 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 1,206 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT04616170, a NA study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
NA
Development phase
1,206 participants
Enrollment target

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.

Primary Outcome

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

Interventions

  • OTHER Usual Care
  • OTHER Hip extension

Trial Details

FieldValue
Enrollment Target 1,206 participants
Start Date 2021-04-05
Est. Completion 2025-07-11
Phase NA
Massachusetts General Hospital

2,032 total trials

What the finished NCT04616170 record still lists

NCT04616170 is an interventional study that assigns participants to a tested intervention. Its 1,206 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (14% lower).

The record links to 0 conditions, and to 2 interventions - of which Usual Care is the first listed.

NCT04616170 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04616170 about?

NCT04616170 is a clinical study titled "The Patient Positioning for Perineal Protection Study". 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 highe...

What is the current status of trial NCT04616170?

This trial is currently completed. It is a NA study. The enrollment target is 1,206 participants. The study started on 2021-04-05. Estimated completion is 2025-07-11.

What interventions are being tested in trial NCT04616170?

The interventions under investigation include: Usual Care (OTHER), Hip extension (OTHER).

Who is sponsoring clinical trial NCT04616170?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04616170's enrollment target sits among peer trials

1,206 83rd of 2000 higher than 1,918 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04616170, the US trial registry maintained by the National Library of Medicine. NCT04616170 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.