Head-perineum Distance and Delivery Mode

NCT ID: NCT04771091

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-08

Study Completion Date

2021-04-04

Brief Summary

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In a prospective cohort of patients in the second phase of labor, the investigators measured the head-perineum distance and correlate it to the mode of delivery (spontaneous delivery - instrumental delivery - ceasarean section).

Detailed Description

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Head-perineum distance measured by transperineal ultrasound is a simple and well-known tool to help diagnose the fetal head engagement and predictive value to instrumental extraction succeeds.

It is performed in labor room and is a non-invasive test, realized on a healthy skin.

The investigators performed a systematical measure of head perineum distance at the beginning of the expulsive labor phase. The investigators made the hypothesis, based on our clinical experience, that starting expulsive labor phase with head perineum distance greater than forty five millimeters, lead to an increased risk of instrumental extraction and therefore an increase in materno-fetal morbidity and mortality.

The investigators sought to evaluate the optimal head perineum distance at the beginning of expulsive efforts.

Conditions

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Pregnancies Obstetric Labor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Mesure of head-perineum distance by transperineal ultrasound

A mesure of head-perineum distance by ultrasound will be realized at the beginning of maternal pushing efforts by a junior gynecologist.

Group Type EXPERIMENTAL

Mesure of head-perineum distance by transperineal ultrasound

Intervention Type DIAGNOSTIC_TEST

A mesure of head-perineum distance by ultrasound will be realized at the beginning of maternal pushing efforts by a junior gynecologist

Interventions

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Mesure of head-perineum distance by transperineal ultrasound

A mesure of head-perineum distance by ultrasound will be realized at the beginning of maternal pushing efforts by a junior gynecologist

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Echography

Eligibility Criteria

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Inclusion Criteria

* Single pregnancy
* In labor (spontaneous or induced)
* Term superior at 37 SA
* Delivery by summit presentation

Exclusion Criteria

* Non single pregnancy
* Suspected malformative abnormalities in the unborn fetus
* Refusal of participation
* Minor patient
* Adult patient subject to legal protection or patient deprived of liberty
* Poor French language understanding
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maela Le Lous, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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Centre Hospitalier Universitaire de Rennes

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC20_3011_EchoPĂ©

Identifier Type: -

Identifier Source: org_study_id

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