Head-perineum Distance and Delivery Mode

Obstetric Labor Clinical Trial

— EchoPé  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771091
• Other study ID #: 35RC20_3011_EchoPé
• Status: Completed
• Phase: N/A
• Start date: July 8, 2020
• Est. completion date: April 4, 2021

Study information

• Verified date: April 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: April 4, 2021
• Est. primary completion date: April 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor
• Pregnancies

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery mode	spontaneous or instrumental vaginal delivery	Day 1