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Completed

NCT Number: NCT04771091

Head-perineum Distance and Delivery Mode

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).

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Rennes

Rennes, 35000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesure of head-perineum distance by transperineal ultrasound

Diagnostic Test

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

Primary outcomes

  1. Delivery mode

    Time frame: Day 1

    spontaneous or instrumental vaginal delivery

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: EchoPé

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2021
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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