EchoPé: Head-perineum Distance and Delivery Mode

Sponsor

Rennes University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04771091

Collaborator

(none)

280

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Pregnancies Obstetric Labor	Diagnostic Test: Mesure of head-perineum distance by transperineal ultrasound	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Correlation Between Head Perineum Distance Measured by Trans-périneal Ultrasound and Delivery Mode in Patient in the Second Stage of Labor

Actual Study Start Date :

Jul 8, 2020

Anticipated Primary Completion Date :

Jul 8, 2021

Anticipated Study Completion Date :

Sep 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Diagnostic Test: 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 Other Names: Echography

Arm

Intervention/Treatment

Experimental: 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.

Diagnostic Test: 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

Other Names:

Echography

Outcome Measures

Primary Outcome Measures

Delivery mode [Day 1]
spontaneous or instrumental vaginal delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Rennes	Rennes		France	35000

Sponsors and Collaborators

Rennes University Hospital

Investigators

Principal Investigator: Maela Le Lous, MD, Rennes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT04771091

Other Study ID Numbers:

35RC20_3011_EchoPé

First Posted:

Feb 25, 2021

Last Update Posted:

Mar 2, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rennes University Hospital

Head perineum distance

ultrasound measure

delivery mode

instrumental delivery

spontaneous delivery

pushing maternal efforts

Study Results

No Results Posted as of Mar 2, 2021