In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

Not Applicable

• Conditions: Perineal Tear; Perineum; Rupture; Perineum; Tear
• Interventions: Other: assessment in the 8th month of pregnancy and during delivery

• Registration Number: NCT05556304
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

• Status Verified: 2022-05
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-22
• Last Update Submitted: 2022-09-22
• Study First Posted: 2022-09-27
• Last Update Posted: 2022-09-27
• Study Start: 2022-10-01
• Primary Completion: 2022-12-01
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
assessment in the 8th month of pregnancy and during delivery	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

Primary Outcome Measures

Name	Time	Method
maximum value of equivalent deformation obtained by stereovision camera	delivery	maximum value of equivalent deformation obtained by stereovision camera

Secondary Outcome Measures

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