In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

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

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

Official Title
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In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

Conditions
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Perineum; Rupture, Perineum; Tear, Perineal Tear

Intervention / Treatment
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* Other: assessment in the 8th month of pregnancy and during delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, longitudinal and single-center study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: assessment in the 8th month of pregnancy and during delivery<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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perineal tear, hyperelasticity