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Completed

NCT Number: NCT07329192

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Advance Selection of a General Practitioner

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

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 ?

Acronym: GENS2-VIE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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