PregnanciesEchoPéNCT04771091
Head-perineum Distance and Delivery Mode
A study testing Mesure of head-perineum distance by transperineal ultrasound in people with Pregnancies and Obstetric Labor, run by Rennes University Hospital at 1 site in France.
Trial summary
In a prospective cohort of patients in the second phase of labor, the investigators measured the head-perineum distance and correlate it to the mode of delivery (spontaneous delivery - instrumental delivery - ceasarean section). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancies, Obstetric Labor
- What is being tested?
- Mesure of head-perineum distance by transperineal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2020to 4 Apr 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single pregnancy
- In labor (spontaneous or induced)
- Term superior at 37 SA
- Delivery by summit presentation
Who cannot join
- Non single pregnancy
- Suspected malformative abnormalities in the unborn fetus
- Refusal of participation
- Minor patient
- Adult patient subject to legal protection or patient deprived of liberty
- Poor French language understanding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Head Perineum Distance Measured by Trans-périneal Ultrasound and Delivery Mode in Patient in the Second Stage of Labor
In a prospective cohort of patients in the second phase of labor, the investigators measured the head-perineum distance and correlate it to the mode of delivery (spontaneous delivery - instrumental delivery - ceasarean section).
Read the detailed description
Head-perineum distance measured by transperineal ultrasound is a simple and well-known tool to help diagnose the fetal head engagement and predictive value to instrumental extraction succeeds.
It is performed in labor room and is a non-invasive test, realized on a healthy skin.
The investigators performed a systematical measure of head perineum distance at the beginning of the expulsive labor phase. The investigators made the hypothesis, based on our clinical experience, that starting expulsive labor phase with head perineum distance greater than forty five millimeters, lead to an increased risk of instrumental extraction and therefore an increase in materno-fetal morbidity and mortality.
The investigators sought to evaluate the optimal head perineum distance at the beginning of expulsive efforts.
- Conditions
- Pregnancies, Obstetric Labor
- Being tested
- Mesure of head-perineum distance by transperineal ultrasound
- Keywords
- Head perineum distance, ultrasound measure, delivery mode, instrumental delivery, spontaneous delivery, pushing maternal efforts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesure of head-perineum distance by transperineal ultrasoundDiagnostic test
Also called Echography
A mesure of head-perineum distance by ultrasound will be realized at the beginning of maternal pushing efforts by a junior gynecologist
| Study group | Role | What they receive |
|---|---|---|
| Mesure of head-perineum distance by transperineal ultrasound | Experimental | A mesure of head-perineum distance by ultrasound will be realized at the beginning of maternal pushing efforts by a junior gynecologist. Receives: Diagnostic Test: Mesure of head-perineum distance by transperineal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery mode
spontaneous or instrumental vaginal delivery
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start8 Jul 2020
- Primary completion4 Apr 2021
- Study completion4 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnanciesStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maela Le Lous, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771091
- Sponsor's protocol ID
- 35RC20_3011_EchoPé
- Acronym
- EchoPé
- Status last verified
- Apr 2023
- First submitted
- 22 Feb 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Head Perineum Distance Measured by Trans-périneal Ultrasound and Delivery Mode in Patient in the Second Stage of Labor
- ClinicalTrials.gov ID
- NCT04771091
- Acronym / sponsor ID
- EchoPé / 35RC20_3011_EchoPé
- Conditions
- Pregnancies, Obstetric Labor
- Keywords
- Head perineum distance, ultrasound measure, delivery mode, instrumental delivery, spontaneous delivery, pushing maternal efforts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 4 Apr 2021 (actual)
- Study completion
- 4 Apr 2021 (actual)
- First posted
- 25 Feb 2021 (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.
In a prospective cohort of patients in the second phase of labor, the investigators measured the head-perineum distance and correlate it to the mode of delivery (spontaneous delivery - instrumental delivery - ceasarean section).
Detailed description
Head-perineum distance measured by transperineal ultrasound is a simple and well-known tool to help diagnose the fetal head engagement and predictive value to instrumental extraction succeeds.
It is performed in labor room and is a non-invasive test, realized on a healthy skin.
The investigators performed a systematical measure of head perineum distance at the beginning of the expulsive labor phase. The investigators made the hypothesis, based on our clinical experience, that starting expulsive labor phase with head perineum distance greater than forty five millimeters, lead to an increased risk of instrumental extraction and therefore an increase in materno-fetal morbidity and mortality.
The investigators sought to evaluate the optimal head perineum distance at the beginning of expulsive efforts.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesure of head-perineum distance by transperineal ultrasound | Experimental | Diagnostic Test: Mesure of head-perineum distance by transperineal ultrasoundA mesure of head-perineum distance by ultrasound will be realized at the beginning of maternal pushing efforts by a junior gynecologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Single pregnancy
- In labor (spontaneous or induced)
- Term superior at 37 SA
- Delivery by summit presentation
Key exclusion criteria (6 listed)
- Non single pregnancy
- Suspected malformative abnormalities in the unborn fetus
- Refusal of participation
- Minor patient
- Adult patient subject to legal protection or patient deprived of liberty
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 |
|---|---|---|
| Mesure of head-perineum distance by transperineal ultrasoundAlso: EchographyA mesure of head-perineum distance by ultrasound will be realized at the beginning of maternal pushing efforts by a junior gynecologist | Diagnostic test | Mesure of head-perineum distance by transperineal ultrasound |
Primary outcome
Delivery mode
Time frame: Day 1
spontaneous or instrumental vaginal delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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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.
Maela Le Lous, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesure of head-perineum distance by transperineal ultrasound in people with Pregnancies and Obstetric Labor, run by Rennes University Hospital at 1 site in France.
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 6 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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Delivery mode (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2023.