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Head-perineum Distance and Delivery Mode (EchoPé)

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ClinicalTrials.gov Identifier: NCT04771091
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 8, 2020
Estimated Primary Completion Date : July 8, 2021
Estimated Study Completion Date : September 8, 2021
Arms and Interventions
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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 Name: Echography


Outcome Measures
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Primary Outcome Measures :
  1. Delivery mode [ Time Frame: Day 1 ]
    spontaneous or instrumental vaginal delivery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771091


Contacts
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Contact: kristell coat 2 99 28 25 55 kristell.coat@chu-rennes.fr
Contact: DRI 2 99 28 25 55 DRI@chu-rennes.fr

Locations
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France
Centre Hospitalier Universitaire de Rennes Recruiting
Rennes, France, 35000
Contact: Maela Le lous, MD       maela.le.lous@chu-rennes.fr   
Contact: Myriam Boulmedais, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Maela Le Lous, MD Rennes University Hospital
More Information
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04771091    
Other Study ID Numbers: 35RC20_3011_EchoPé
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
Head perineum distance
ultrasound measure
delivery mode
 instrumental delivery
spontaneous delivery
pushing maternal efforts