In Vivo Evaluation of Perineal Mechanical Properties During Childbirth (MecaPer)

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Perineum; Tear; Perineum; Rupture; Perineal Tear

Treatments: Other: assessment in the 8th month of pregnancy and during delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT05556304

2022/694

Details and patient eligibility

About

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

Full description

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

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

assessment in the 8th month of pregnancy and during delivery

Other group

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

Treatment:

Other: assessment in the 8th month of pregnancy and during delivery