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In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

NCT05556304 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-09-27

No results posted yet for this study

Summary

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

Conditions

  • Perineum; Rupture
  • Perineum; Tear
  • Perineal Tear

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2022-12-01
Completion
2023-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05556304 on ClinicalTrials.gov