In Vivo Evaluation of Perineal Mechanical Properties During Childbirth (MecaPer)

The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.

Study Overview

• Status: Not yet recruiting
• Conditions: Perineal Tear; Perineum; Rupture; Perineum; Tear
• Intervention / Treatment: Other: assessment in the 8th month of pregnancy and during delivery

Detailed Description

The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant and volunteer women >18 years old
• Primiparous
• With a singleton pregnancy
• No objection from the subject and the spouse to participate in the study

Exclusion Criteria:

• History of prior delivery or c-section
• History of perineal troubles
• BMI > à 35 mg/m²
• History of chronic muscular disease or connective tissue pathology
• Psychiatric pathology requiring hospitalization
• Patients who do not understand the French language
• Legal incapacity or limited legal capacity
• Patients unlikely to cooperate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: assessment in the 8th month of pregnancy and during delivery; The study design includes a consultation during pregnancy between 36 and 38 weeks of gestation and an assessment in the delivery room during childbirth

Other: assessment in the 8th month of pregnancy and during delivery; Day 0: presentation of the study; During pregnancy between Day 0 and 36-38SA: inclusion; During pregnancy: collection of pelvic MRI data if performed during pregnancy for maternal or fetal reasons; Between 36 and 38 WG: collection of demographic, obstetrical, fetal ultrasound and clinical data / Perineal elastographic recording / Recording of the perineal deformation by stereovision camera; In the delivery room, at the beginning of labor and before pushing: collection of clinical data / Collection of obstetrical ultrasound data / Perineal elastographic recordings / Recording of the perineal deformation by stereovision camera; In the delivery room, during expulsion : recording of the perineal deformation by stereovision camera; In the delivery room, after childbirth: collection of obstetrical, clinical and neonatal data / Perineal elastographic recordings / Cephalic and shoulder measurements of the newborn with a tape measure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum value of equivalent deformation obtained by stereovision camera	maximum value of equivalent deformation obtained by stereovision camera	delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB	Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB	pregnancy
Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB	elta between the minimum and maximum width of GH, and between the maximum and minimum length of PB	delivery
Correlation between perineal deformation values and perineal tears	Correlation between perineal deformation values and perineal tears	delivery
Correlation between perineal deformation values and fetal parameters	Correlation between perineal deformation values and fetal parameters	pregnancy
Correlation between perineal deformation values and fetal parameters	Correlation between perineal deformation values and fetal parameters	delivery
Correlation between fetal ultrasound and neonatal parameters and perineal tears	Correlation between fetal ultrasound and neonatal parameters and perineal tears	delivery
Evolution of the elasticity of the perineal body and the SAE during delivery	Evolution of the elasticity of the perineal body and the SAE during delivery	delivery
Correlation between elasticity of the perineal body and perineal tears	Correlation between elasticity of the perineal body and perineal tears	pregnancy
Correlation between elasticity of the perineal body and perineal tears	Correlation between elasticity of the perineal body and perineal tears	delivery
Correlation between the elasticity of the external anal sphincter and perineal tears	Correlation between the elasticity of the external anal sphincter and perineal tears	pregnancy
Correlation between the elasticity of the external anal sphincter and perineal tears	Correlation between the elasticity of the external anal sphincter and perineal tears	delivery

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): October 30, 2023

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: perineal tear; hyperelasticity
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 2022/694

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No