Ultrasonography, PrenatalECHOTRANSNCT02456753
Assesment by Ultrasonography of the Perineal-cephalic Distance
An observational study of Ultrasonography, Prenatal, run by Lille Catholic University at 1 site in France.
Trial summary
The practice of ultrasounds increases in delivery rooms every year. Indeed, this method can help to visualize elements that may not be observable after clinical examination. Moreover, it is known that a fetal head engagement can lead to an instrumental extraction and in case of error, which happens in some cases… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ultrasonography, Prenatal
- What is being tested?
- trans-perineal ultrasonography
- Type of treatment
- Medical device
- How many people
- 411 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Sep 2015
- Phase
- Observational
- 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
Study population: Patients included are women about to give birth, they undergo a clinical examination done by midwives. Followed by a trans-perineal ultrasonography examination done by a technical operator in order to measure the perineal-cephalic distance. These examination are done the day of enrollment, they last for a few minutes and no further tests will be done afterwards.
Who may be able to join
- Patients of 18 years old or older
- Primiparous
- Complete dilation of the cervix
- Gestational age of 37 weeks or more according to the date of amenorrhea - - Rupture of membranes
- Fetus in cephalic presentation
- Patient who has signed a consent form
Who cannot join
- Patient for whom the fetus has died in uteri
- Patient who's coming for an abortion
- Fetus in breech or transverse presentation
- Gemellary pregnancy for which the fetus present a severe cardiac anomaly
- Patient under trusteeship or guardianship
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Saint Vincent de Paul (GHICL)
Lille, Hauts-de-France, 59000
About this study
Official title: Assesment by Ultrasonography of the Perineal-cephalic Distance in Consistence With the Notion of Clinical Fetal Head Engagement
The practice of ultrasounds increases in delivery rooms every year. Indeed, this method can help to visualize elements that may not be observable after clinical examination. Moreover, it is known that a fetal head engagement can lead to an instrumental extraction and in case of error, which happens in some cases, fetal and maternal risks are possible.
These elements led to the investigators' hypothesis which is that a trans-perineal ultrasonography may facilitate the evaluation of a clinical fetal head engagement in case of doubt.
Read the detailed description
It's a monocentric, transversal, clinical trial regarding women giving birth at the GHICL's hospital Saint Vincent de Paul.
Clinical examinations will be done by the midwives following the indications given on the clinical form. A trans-perineal echography will then be done by technical operators following the ultrasonography form.
These examinations will only last a few minutes, no further tests will be done afterwards.
- Conditions
- Ultrasonography, Prenatal
- Being tested
- trans-perineal ultrasonography
- Keywords
- in labor, Ultrasonography, clinical examination, Prenatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trans-perineal ultrasonographyDevice
Assesment of the fetal head-perineum distance via a trans-perineal ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| trans-perineal ultrasonography | Patients included are women about to give birth, they undergo a clinical examination done by midwives. Followed by a trans-perineal ultrasonography examination done by a technical operator in order to measure the perineal-cephalic distance.
These examination are done the day of enrollment, they last for a few minutes and no further tests will be done afterwards. Receives: Device: trans-perineal ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal-cephalic distance measured in milimeters
Determine the perineal-cephalic distance via echographic examination, which gives a better sensitivity/specificity in comparison to the clinical examination considered as a gold standard
Measured: one day
Secondary outcomes (1)
Perineal-cephalic distance measured in milimeters according to specific conditions: posterior positions, th etime from induction to delivery, presence of caput succedaneum
Determine the interest of the echography measurement in specific conditions (variety of posterior presentations, caput succedaneum, work stagnation) regarding the diagnosis of engagement, in case of doubt concerning the clinical examination
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasonography, PrenatalStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Desurmont, MD, Principal investigator, Groupment des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456753
- Sponsor's protocol ID
- RC-P0024
- Acronym
- ECHOTRANS
- Status last verified
- Sep 2016
- First submitted
- 13 Apr 2015
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment by Ultrasonography of the Perineal-cephalic Distance in Consistence With the Notion of Clinical Fetal Head Engagement
- ClinicalTrials.gov ID
- NCT02456753
- Acronym / sponsor ID
- ECHOTRANS / RC-P0024
- Conditions
- Ultrasonography, Prenatal
- Keywords
- in labor, Ultrasonography, clinical examination, Prenatal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 May 2015 (estimated)
- 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 practice of ultrasounds increases in delivery rooms every year. Indeed, this method can help to visualize elements that may not be observable after clinical examination. Moreover, it is known that a fetal head engagement can lead to an instrumental extraction and in case of error, which happens in some cases, fetal and maternal risks are possible.
These elements led to the investigators' hypothesis which is that a trans-perineal ultrasonography may facilitate the evaluation of a clinical fetal head engagement in case of doubt.
Detailed description
It's a monocentric, transversal, clinical trial regarding women giving birth at the GHICL's hospital Saint Vincent de Paul.
Clinical examinations will be done by the midwives following the indications given on the clinical form. A trans-perineal echography will then be done by technical operators following the ultrasonography form.
These examinations will only last a few minutes, no further tests will be done afterwards.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trans-perineal ultrasonography | – | Device: trans-perineal ultrasonographyPatients included are women about to give birth, they undergo a clinical examination done by midwives. Followed by a trans-perineal ultrasonography examination done by a technical operator in order to measure the perineal-cephalic distance. These examination are done the day of enrollment, they last for a few minutes and no further tests will be done afterwards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included are women about to give birth, they undergo a clinical examination done by midwives. Followed by a trans-perineal ultrasonography examination done by a technical operator in order to measure the perineal-cephalic distance. These examination are done the day of enrollment, they last for a few minutes and no further tests will be done afterwards.
Key inclusion criteria (6 listed)
- Patients of 18 years old or older
- Primiparous
- Complete dilation of the cervix
- Gestational age of 37 weeks or more according to the date of amenorrhea - - Rupture of membranes
- Fetus in cephalic presentation
Key exclusion criteria (5 listed)
- Patient for whom the fetus has died in uteri
- Patient who's coming for an abortion
- Fetus in breech or transverse presentation
- Gemellary pregnancy for which the fetus present a severe cardiac anomaly
- Patient under trusteeship or guardianship
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 |
|---|---|---|
| trans-perineal ultrasonographyAssesment of the fetal head-perineum distance via a trans-perineal ultrasonography | Device | trans-perineal ultrasonography |
Primary outcome
Perineal-cephalic distance measured in milimeters
Time frame: one day
Determine the perineal-cephalic distance via echographic examination, which gives a better sensitivity/specificity in comparison to the clinical examination considered as a gold standard
1 secondary outcome
Perineal-cephalic distance measured in milimeters according to specific conditions: posterior positions, th etime from induction to delivery, presence of caput succedaneum
Time frame: one day
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 20 Sep 2016.
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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.
Sophie Desurmont, MD principal investigator
Groupment des Hôpitaux de l'Institut Catholique de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasonography, Prenatal, run by Lille Catholic University 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 6 inclusion and 5 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 20 Sep 2016. 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?
Perineal-cephalic distance measured in milimeters (time frame: one day). 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 20 Sep 2016.