Study on How Parents' Anticipated Choice of a Doctor at the Maternity Hospital Influences the Newborn's First Post-discharge Consultation
GENS2-VIE
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 ?
1 other identifier
observational
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2026
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2025
CompletedFirst Posted
Study publicly available on registry
January 9, 2026
CompletedStudy Start
First participant enrolled
January 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2026
CompletedMarch 19, 2026
March 1, 2026
2 months
December 8, 2025
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Timely completion of the newborn's first post-discharge medical examination
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 Outcomes (4)
Sociodemographic data of the parents' choice of physician for the newborn's first consultation
at day 0
Questions regarding the first post-hospitalization consultation
at maternity (assessed up to day 7)
Concordance between the physician designated in maternity and the physician who performed the consultation
at 1 month
Factors associated with delayed completion of the newborn's first consultation
at 1 month
Study Arms (1)
newborn
newborn
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100, France
Study Officials
- PRINCIPAL INVESTIGATOR
Marion BATHANY, MD
Centre Hospitalier Sud Francilien
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2025
First Posted
January 9, 2026
Study Start
January 13, 2026
Primary Completion
March 2, 2026
Study Completion
March 2, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share