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In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05556304
Acronym
MecaPer
Enrollment
10
Registered
2022-09-27
Start date
2022-10-01
Completion date
2023-10-30
Last updated
2022-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineal Tear, Perineum; Rupture, Perineum; Tear

Keywords

perineal tear, hyperelasticity

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.

Interventions

OTHERassessment 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

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

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

Intervention model description

prospective, longitudinal and single-center study

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
maximum value of equivalent deformation obtained by stereovision cameradeliverymaximum value of equivalent deformation obtained by stereovision camera

Secondary

MeasureTime frameDescription
Correlation between perineal deformation values and perineal tearsdeliveryCorrelation between perineal deformation values and perineal tears
Correlation between perineal deformation values and fetal parameterspregnancyCorrelation between perineal deformation values and fetal parameters
Correlation between fetal ultrasound and neonatal parameters and perineal tearsdeliveryCorrelation between fetal ultrasound and neonatal parameters and perineal tears
Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PBpregnancyDelta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
Correlation between elasticity of the perineal body and perineal tearspregnancyCorrelation between elasticity of the perineal body and perineal tears
Correlation between the elasticity of the external anal sphincter and perineal tearspregnancyCorrelation between the elasticity of the external anal sphincter and perineal tears
Evolution of the elasticity of the perineal body and the SAE during deliverydeliveryEvolution of the elasticity of the perineal body and the SAE during delivery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026