Perineum; RuptureMecaPerNCT05556304
In Vivo Evaluation of Perineal Mechanical Properties During Childbirth
A study testing assessment in the 8th month of pregnancy and during delivery in people with Perineum; Rupture and Perineum; Tear, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perineum; Rupture, Perineum; Tear, Perineal Tear
- What is being tested?
- assessment in the 8th month of pregnancy and during delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.
Read the detailed description
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
- Being tested
- assessment in the 8th month of pregnancy and during delivery
- Keywords
- perineal tear, hyperelasticity
- Medical subject headings
- Rupture, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: assessment in the 8th month of pregnancy and during delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum value of equivalent deformation obtained by stereovision camera
maximum value of equivalent deformation obtained by stereovision camera
Measured: delivery
Secondary outcomes (11)
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
Measured: pregnancy
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
Measured: delivery
Correlation between perineal deformation values and perineal tears
Correlation between perineal deformation values and perineal tears
Measured: delivery
Correlation between perineal deformation values and fetal parameters
Correlation between perineal deformation values and fetal parameters
Measured: pregnancy
Correlation between perineal deformation values and fetal parameters
Correlation between perineal deformation values and fetal parameters
Measured: delivery
Correlation between fetal ultrasound and neonatal parameters and perineal tears
Correlation between fetal ultrasound and neonatal parameters and perineal tears
Measured: delivery
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
Measured: delivery
Correlation between elasticity of the perineal body and perineal tears
Correlation between elasticity of the perineal body and perineal tears
Measured: pregnancy
Correlation between elasticity of the perineal body and perineal tears
Correlation between elasticity of the perineal body and perineal tears
Measured: delivery
Correlation between the elasticity of the external anal sphincter and perineal tears
Correlation between the elasticity of the external anal sphincter and perineal tears
Measured: pregnancy
Correlation between the elasticity of the external anal sphincter and perineal tears
Correlation between the elasticity of the external anal sphincter and perineal tears
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perineum; RuptureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, longitudinal and single-center study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556304
- Sponsor's protocol ID
- 2022/694
- Acronym
- MecaPer
- Status last verified
- May 2022
- First submitted
- 19 Sep 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40107173Lallemant 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.
PubMed 39805482
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Evaluation of Perineal Mechanical Properties During Childbirth
- ClinicalTrials.gov ID
- NCT05556304
- Acronym / sponsor ID
- MecaPer / 2022/694
- Conditions
- Perineum; Rupture, Perineum; Tear, Perineal Tear
- Keywords
- perineal tear, hyperelasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this work is to evaluate perineal elasticity and deformation and the perineal stresses induced by the fetus during delivery.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, longitudinal and single-center study
| Arm | Type | Receives |
|---|---|---|
| assessment in the 8th month of pregnancy and during delivery | Other | Other: assessment in the 8th month of pregnancy and during deliveryThe study design includes a consultation during pregnancy between 36 and 38 weeks of gestation and an assessment in the delivery room during childbirth |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | assessment in the 8th month of pregnancy and during delivery |
Primary outcome
maximum value of equivalent deformation obtained by stereovision camera
Time frame: delivery
maximum value of equivalent deformation obtained by stereovision camera
11 secondary outcomes
Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
Time frame: pregnancy
Delta between the minimum and maximum width of GH, and between the maximum and minimum length of PB
Time frame: delivery
Correlation between perineal deformation values and perineal tears
Time frame: delivery
Correlation between perineal deformation values and fetal parameters
Time frame: pregnancy
Correlation between perineal deformation values and fetal parameters
Time frame: delivery
Correlation between fetal ultrasound and neonatal parameters and perineal tears
Time frame: delivery
Evolution of the elasticity of the perineal body and the SAE during delivery
Time frame: delivery
Correlation between elasticity of the perineal body and perineal tears
Time frame: pregnancy
Correlation between elasticity of the perineal body and perineal tears
Time frame: delivery
Correlation between the elasticity of the external anal sphincter and perineal tears
Time frame: pregnancy
Correlation between the elasticity of the external anal sphincter and perineal tears
Time frame: delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Derived from this study: PubMed 40107173Lallemant 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.
- Derived from this study: PubMed 39805482Lallemant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing assessment in the 8th month of pregnancy and during delivery in people with Perineum; Rupture and Perineum; Tear, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum value of equivalent deformation obtained by stereovision camera (time frame: delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05556304, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2022.