Quality of Information Provided During Antenatal Consultations (EVIDANCE)

February 10, 2025 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Survey
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
The outcome is measured at the time of questionnaire completion, typically at hospital discharge or within one week post-discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-5216

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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