Study on How Parents' Anticipated Choice of a Doctor at the Maternity Hospital Influences the Newborn's First Post-discharge Consultation (GENS2-VIE)

March 18, 2026 updated by: Centre Hospitalier Sud Francilien

First Required Medical Examination of the Newborn After Discharge From the Maternity Hospital: Does the Choice of a General Practitioner Facilitate Its Completion Within the Recommended Timeframe ?

The goal of this observational study is to determine whether, in a population of well-informed parents, choosing a general practitioner at the maternity hospital facilitates the completion of the newborn's first required medical examination within the second week of life.

The main question it aims to answer is: Does selecting a general practitioner before leaving the maternity hospital allow the newborn's first medical examination to be completed within the recommended period?

Participants will be asked to complete an initial questionnaire, which will be given to them before leaving the maternity hospital, and then a second questionnaire by telephone one month later.

Study Overview

Status

Completed

Conditions

Detailed Description

For eligible newborns, an information sheet will be provided to the parents or legal guardians.

Parents or legal guardians who have been informed of the study and do not object to their child's participation will receive a questionnaire between the second postnatal day (D2) and discharge from the maternity ward.

Each completed questionnaire will be collected prior to discharge. The research team will then contact the parents by telephone on day 30 (±3 days) to administer the second questionnaire and record their responses.

Study Type

Observational

Enrollment (Actual)

120

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
      • Corbeil-Essonnes, France, France, 91100
        • Centre Hospitalier Sud Francilien

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Healthy term newborns recruited prior to discharge from the maternity hospital. Included infants are healthy term newborns (≥37 weeks of gestation, birth weight >3000 g) with no antenatal or postnatal pathology requiring hospitalization. Parents or legal guardians must understand the study information and not object to participation.

Description

Inclusion Criteria:

  • Term newborn ≥ 37 weeks of gestation
  • Birth weight > 3000 g
  • Growth > 5th percentile according to Fenton curves
  • No diagnosed or suspected pathology during antenatal care or the maternity stay
  • No postnatal complications requiring temporary hospitalization in the neonatal unit or kangaroo care unit

Exclusion Criteria:

  • Pathology diagnosed or suspected in the newborn during the maternity hospital stay.
  • Requirement for temporary hospitalization in a neonatal unit or kangaroo care unit, including but not limited to: neonatal jaundice, abnormal oxygenation or laboratory findings, suspected early-onset bacterial infection, transient respiratory distress requiring more than 2 hours of non-invasive ventilation at birth, monitoring of mother-infant bonding, or maternal treatments during pregnancy necessitating clinical monitoring.
  • Language barrier in both parents.
  • Parents (legal guardians) informed of the study and having declined participation for themselves and their child.

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
newborn

This exposure refers to parents selecting a general practitioner for their newborn before discharge from the maternity hospital.

It represents a routine-care organizational choice that may influence whether the first post-discharge medical examination is completed within the recommended period. No study-specific procedures or treatments are administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timely completion of the newborn's first post-discharge medical examination
Time Frame: at 1 month

Assessment of whether the newborn's first medical examination after discharge from the maternity hospital is performed within the recommended period (second week of life, between day 8 and day 15).

The outcome is measured as a binary variable: completed within the recommended period / not completed within the recommended period.

at 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic data of the parents' choice of physician for the newborn's first consultation
Time Frame: at day 0
Assessment of parental (sociodemographic, organizational, informational) and neonatal (clinical, perinatal) characteristics associated with the selection of the physician designated to perform the newborn's first post-discharge consultation.
at day 0
Questions regarding the first post-hospitalization consultation
Time Frame: at maternity (assessed up to day 7)
Evaluation of the information received by parents and their level of knowledge regarding the purpose, timing, and importance of the newborn's first post-discharge consultation, including awareness of recommended guidelines.
at maternity (assessed up to day 7)
Concordance between the physician designated in maternity and the physician who performed the consultation
Time Frame: at 1 month
Comparison between the physician chosen by parents before hospital discharge and the physician who actually performed the newborn's first medical examination.
at 1 month
Factors associated with delayed completion of the newborn's first consultation
Time Frame: at 1 month

Identification of parental, organizational, and neonatal factors associated with completion of the first consultation after the recommended period.

Outcome measured as timely vs. delayed, with analysis of associated covariates.

at 1 month

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Marion BATHANY, MD, Centre Hospitalier Sud Francilien

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)

January 13, 2026

Primary Completion (Actual)

March 2, 2026

Study Completion (Actual)

March 2, 2026

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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