NCT06820892

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2025

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

February 5, 2025

Last Update Submit

February 10, 2025

Conditions

Keywords

AntenatalAntenatal consultationinformation

Outcome Measures

Primary Outcomes (1)

  • 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'.

    The outcome is measured at the time of questionnaire completion, typically at hospital discharge or within one week post-discharge.

Study Arms (1)

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

Interventions

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.

Patients (mother only)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Femme Mère Enfant Hospital (HFME)

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Congenital AbnormalitiesPremature Birth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 11, 2025

Study Start

August 2, 2024

Primary Completion

March 1, 2025

Study Completion

March 15, 2025

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations