MecaPer: In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05556304

Collaborator

(none)

Enrollment

Arm

12.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Perineum; Rupture Perineum; Tear Perineal Tear	Other: assessment in the 8th month of pregnancy and during delivery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

prospective, longitudinal and single-center studyprospective, longitudinal and single-center study

Masking:

None (Open Label)

Masking Description:

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 Purpose:

Basic Science

Official Title:

In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

maximum value of equivalent deformation obtained by stereovision camera [delivery]
maximum value of equivalent deformation obtained by stereovision camera

Secondary Outcome Measures

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
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 perineal deformation values and perineal tears [delivery]
Correlation between perineal deformation values and perineal tears
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 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 [pregnancy]
Correlation between elasticity of the perineal body and perineal tears
Correlation between elasticity of the perineal body and perineal tears [delivery]
Correlation between elasticity of the perineal body 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]
Correlation between the elasticity of the external anal sphincter and perineal tears

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT05556304

Other Study ID Numbers:

2022/694

First Posted:

Sep 27, 2022

Last Update Posted:

Sep 27, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Besancon

perineal tear

hyperelasticity

Additional relevant MeSH terms:

Rupture

Study Results

No Results Posted as of Sep 27, 2022