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NCT05556304 | Not yet recruiting | Perineum; Rupture


In Vivo Evaluation of Perineal Mechanical Properties During Childbirth
Sponsor:

Besancon University Hospital Center

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

Perineum; Rupture

Perineum; Tear

Perineal Tear

Intervention/treatment

assessment in the 8th month of pregnancy and during delivery

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 10 participants
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
Actual Study Start Date : October 1, 2022
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : October 30, 2023
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

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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

In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

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In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

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