NCT05556304

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 27, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

September 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

September 19, 2022

Last Update Submit

September 22, 2022

Conditions

Perineum; RupturePerineum; TearPerineal Tear

Keywords

perineal tearhyperelasticity

Outcome Measures

Primary Outcomes (1)

  • maximum value of equivalent deformation obtained by stereovision camera

    maximum value of equivalent deformation obtained by stereovision camera

    delivery

Secondary Outcomes (11)

  • Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB

    pregnancy

  • Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB

    delivery

  • Correlation between perineal deformation values and perineal tears

    delivery

  • Correlation between perineal deformation values and fetal parameters

    pregnancy

  • Correlation between perineal deformation values and fetal parameters

    delivery

  • +6 more secondary outcomes

Study Arms (1)

assessment in the 8th month of pregnancy and during delivery

OTHER

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

Interventions

assessment in the 8th month of pregnancy and during deliveryOTHER

* 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

assessment in the 8th month of pregnancy and during delivery

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Lallemant M, Kadiake T, Lejeune A, Cosson M, Chambert J, Jacquet E, Mottet N. Perineal body and anal sphincter biometrics and stiffness using elastography during labor: a feasibility study. Eur J Obstet Gynecol Reprod Biol. 2025 May;309:48-54. doi: 10.1016/j.ejogrb.2025.03.034. Epub 2025 Mar 12.

    PMID: 40107173DERIVED

  • Lallemant M, Kadiake T, Lejeune A, Cosson M, Chambert J, Jacquet E, Mottet N. Exploring the influence of perineal biometrics and stiffness measured by elastography during pregnancy on perineal tears : A pilot study. J Gynecol Obstet Hum Reprod. 2025 Mar;54(3):102904. doi: 10.1016/j.jogoh.2025.102904. Epub 2025 Jan 11.

    PMID: 39805482DERIVED

MeSH Terms

Conditions

RuptureLacerations

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The study design includes a consultation during pregnancy between 36 and 38 weeks of gestation and an assessment in the delivery room during childbirth
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: prospective, longitudinal and single-center study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 27, 2022

Study Start

October 1, 2022

Primary Completion

December 1, 2022

Study Completion

October 30, 2023

Last Updated

September 27, 2022

Record last verified: 2022-05