In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-10-30

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.

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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.

Conditions

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Perineum; Rupture Perineum; Tear Perineal Tear

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

prospective, longitudinal and single-center study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

The study design includes a consultation during pregnancy between 36 and 38 weeks of gestation and an assessment in the delivery room during childbirth

Study Groups

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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

Group Type OTHER

assessment in the 8th month of pregnancy and during delivery

Intervention Type OTHER

* 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

Interventions

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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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes