Pertinence of Pediatric Message Delivered to Parents During Antenatal Consultations (INFONEO)

July 19, 2022 updated by: Jean-Michel HASCOET, Central Hospital, Nancy, France

Antenatal consultations are experienced as traumatic for many couples. Moreover, when informations are given urgently ; comprehension and psychological impact aren't well evaluate.

This project aims to evaluate comprehension and psychological impact, for both members of the couple, when informations are provided urgently or during usual consultations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

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

Study Locations

  • France
      • Nancy, France
        • CHRU Nancy - Maternité Régionale

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All parents with need antenatal pediatric urgently or usual consultation

Description

Inclusion Criteria:

  • Parents whom pregnancies need antenatal pediatric consultation
  • Non opposition

Exclusion Criteria:

  • < 18 years old
  • Psychiatric illness

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
Parents after pediatric antenatal consultation
Survey after pediatric antenatal consultation, for both members of couple if possible
Other: Pediatric consultation's survey
Realization of a pediatric consultation. At the end, evaluation of comprehension and psychological impact with a survey (completed by parents).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comprehension and psychological impact ; urgently informations compared with usual consultations
Time Frame: At pregnancy follow-up visit up to 36 weeks gestation

After non opposition, surveys are given to parents

Scale built by investigators. With items about comprehension and psychological impact. From 0 to 23. One point per item. Higher values (23/23) represent a better outcome (comprehension and good psychological impact (0/23 if not)).
At pregnancy follow-up visit up to 36 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between both members of the couple
Time Frame: At pregnancy follow-up visit up to 36 weeks gestation

Same survey for both members, evaluation and comparison of answers.

Same scale
At pregnancy follow-up visit up to 36 weeks gestation
Comprehension and psychological impact, at pregnancy's theoric term compared with first survey Same scale
Time Frame: At delivery at 41 weeks gestation
Same survey, realized at pregnancies' theoric terms
At delivery at 41 weeks gestation

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Jean-Michel HASCOET, MD, PhD, CHRU Nancy - Maternité Régionale

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)

February 13, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

July 2, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSS2018/INFONEO-HASCOET/NK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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