Congenital AnomaliesEVIDANCENCT06820892
Quality of Information Provided During Antenatal Consultations
An observational study of Congenital Anomalies and Prematurity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The objective of this questionnaire study is to evaluate the concordance between the information provided to parents during antenatal consultations and their subsequent experiences following childbirth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Congenital Anomalies, Prematurity, Antenatal Consultation
- What is being tested?
- Survey
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2024to 15 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Of the patients who were followed up at the multidisciplinary prenatal diagnosis centre and had an antenatal consultation with a pediatric neonatologist, 113 patients met the inclusion criteria.
Who may be able to join
- Patients were observed at the multidisciplinary prenatal diagnosis centre.
- Patients who had attended at least one antenatal consultation with a pediatric neonatologist
- Patients who gave birth between January 2020 and December 2022 and whose newborn was hospitalized in the neonatology department
Who cannot join
- a child who died in hospital or had a condition with a high risk of death in the first few years of life
- non-French speaking mothers
- Mothers who were minors at the time of the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Femme Mère Enfant Hospital (HFME)
Bron, 69500
Hélène GAUTHIER MOULINIER, MD, +33427855284, Helene.gauthier-moulinier@chu-lyon.fr
About this study
Official title: Evaluation of the Concordance Between the Information Delivered in Antenatal Diagnosis Consultation and Parents Experience After the Birth of Their Infant
The objective of this questionnaire study is to evaluate the concordance between the information provided to parents during antenatal consultations and their subsequent experiences following childbirth.
- Conditions
- Congenital Anomalies, Prematurity, Antenatal Consultation
- Being tested
- Survey
- Keywords
- Antenatal, Antenatal consultation, information
- Medical subject headings
- Congenital Abnormalities, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
The study utilised a 16-item questionnaire to evaluate the quality of information received during antenatal diagnosis consultations and its congruence with subsequent experiences following birth and hospitalisation of the infant. The questionnaire encompassed seven questions pertaining to consultation arrangements, including duration, frequency and unit visits, six questions addressing the received information, and three questions exploring the long-term outcomes of the child.
| Study group | Role | What they receive |
|---|---|---|
| Patients (mother only) | The patients were observed in a multidisciplinary prenatal diagnosis centre and subsequently delivered a newborn infant, who was then admitted to the neonatology department of the same hospital, between January 2020 and December 2022. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Question 8 of the questionnaire
In summary, did the information provided during the consultation with the paediatrician correspond to the events that transpired during your child's hospitalisation ? Patients are invited to indicate their level of agreement or disagreement with a series of four statements by selecting one of four options : 'not at all', 'to some extent', 'almost' or 'completely'.
Measured: The outcome is measured at the time of questionnaire completion, typically at hospital discharge or within one week post-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start2 Aug 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital AnomaliesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820892
- Sponsor's protocol ID
- 24-5216
- Acronym
- EVIDANCE
- Status last verified
- Feb 2025
- First submitted
- 5 Feb 2025
- Last updated
- 11 Feb 2025
- 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 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Concordance Between the Information Delivered in Antenatal Diagnosis Consultation and Parents Experience After the Birth of Their Infant
- ClinicalTrials.gov ID
- NCT06820892
- Acronym / sponsor ID
- EVIDANCE / 24-5216
- Conditions
- Congenital Anomalies, Prematurity, Antenatal Consultation
- Keywords
- Antenatal, Antenatal consultation, information
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 11 Feb 2025 (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 questionnaire study is to evaluate the concordance between the information provided to parents during antenatal consultations and their subsequent experiences following childbirth.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients (mother only) | – | Other: SurveyThe patients were observed in a multidisciplinary prenatal diagnosis centre and subsequently delivered a newborn infant, who was then admitted to the neonatology department of the same hospital, between January 2020 and December 2022. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Of the patients who were followed up at the multidisciplinary prenatal diagnosis centre and had an antenatal consultation with a pediatric neonatologist, 113 patients met the inclusion criteria.
Key inclusion criteria (3 listed)
- Patients were observed at the multidisciplinary prenatal diagnosis centre.
- Patients who had attended at least one antenatal consultation with a pediatric neonatologist
- Patients who gave birth between January 2020 and December 2022 and whose newborn was hospitalized in the neonatology department
Key exclusion criteria (3 listed)
- a child who died in hospital or had a condition with a high risk of death in the first few years of life
- non-French speaking mothers
- Mothers who were minors at the time of the study
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 |
|---|---|---|
| SurveyThe study utilised a 16-item questionnaire to evaluate the quality of information received during antenatal diagnosis consultations and its congruence with subsequent experiences following birth and hospitalisation of the infant. The questionnaire encompassed seven questions pertaining to consultation arrangements, including duration, frequency and unit visits, six questions addressing the received information, and three questions exploring the long-term outcomes of the child. | Other | Patients (mother only) |
Primary outcome
Question 8 of the questionnaire
Time frame: The outcome is measured at the time of questionnaire completion, typically at hospital discharge or within one week post-discharge.
In summary, did the information provided during the consultation with the paediatrician correspond to the events that transpired during your child's hospitalisation ? Patients are invited to indicate their level of agreement or disagreement with a series of four statements by selecting one of four options : 'not at all', 'to some extent', 'almost' or 'completely'.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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.
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 Congenital Anomalies and Prematurity, run by Hospices Civils de Lyon 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cosima BABINET (+33608161034, cosima.babinet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Question 8 of the questionnaire (time frame: The outcome is measured at the time of questionnaire completion, typically at hospital discharge or within one week post-discharge.). 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 11 Feb 2025.