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NCT05556304 Clinical Trial

In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

Perineal Tear Clinical Trial

— MecaPer  

Official title:
In Vivo Evaluation of Perineal Mechanical Properties During Childbirth

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05556304
Other study ID # 2022/694
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date October 30, 2023

Study information
Verified date May 2022
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date October 30, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome
Type Measure Description Time frame Safety issue
Primary maximum value of equivalent deformation obtained by stereovision camera maximum value of equivalent deformation obtained by stereovision camera delivery
Secondary 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 pregnancy
Secondary Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB elta between the minimum and maximum width of GH, and between the maximum and minimum length of PB delivery
Secondary Correlation between perineal deformation values and perineal tears Correlation between perineal deformation values and perineal tears delivery
Secondary Correlation between perineal deformation values and fetal parameters Correlation between perineal deformation values and fetal parameters pregnancy
Secondary Correlation between perineal deformation values and fetal parameters Correlation between perineal deformation values and fetal parameters delivery
Secondary Correlation between fetal ultrasound and neonatal parameters and perineal tears Correlation between fetal ultrasound and neonatal parameters and perineal tears delivery
Secondary Evolution of the elasticity of the perineal body and the SAE during delivery Evolution of the elasticity of the perineal body and the SAE during delivery delivery
Secondary Correlation between elasticity of the perineal body and perineal tears Correlation between elasticity of the perineal body and perineal tears pregnancy
Secondary Correlation between elasticity of the perineal body and perineal tears Correlation between elasticity of the perineal body and perineal tears delivery
Secondary Correlation between the elasticity of the external anal sphincter and perineal tears Correlation between the elasticity of the external anal sphincter and perineal tears pregnancy
Secondary 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
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Completed NCT03163160 - Electrolysis Technique vs Manual Therapy in Pelvic Pain N/A
Completed NCT05282160 - The Influence of Prepartum Perineal Training With the Epi-No Device on Pelvic Floor Function. N/A
Completed NCT05955352 - The Effect of Using Perineal Warm Compress Techniques During the Second Stage of Labor on Perineal Outcomes N/A
Completed NCT03559816 - Selective Use of Episiotomy: the Impact on Perineal Trauma.
Recruiting NCT04544488 - Descriptive Evaluation of Expulsive Efforts During Pregnancy in Term Nulliparous Women by Measurement of Intra Bladder Pressure: Pilot Observational Study. N/A
Completed NCT03770962 - One Plus One Equals Two, Will That do? N/A
Completed NCT05946005 - Lidocaine, Povidone Iodine, and Honey Application on Second-degree Perineal Tear Healing Phase 4
Completed NCT05962918 - Perineal Massage Performed During the Labour N/A
Completed NCT04370340 - Application of a Perineal Protection Device in Vacuum-assisted Births Phase 3