NCT03114930

Brief Summary

Prior to the HAS recommendations of March 2014, the "mother - newborn" couple was discharged from the maternity home at 4 days after delivery by AVB and 5 days after caesarean section. The stay in maternity allowed a follow-up of the newborn whose weight gain and the occurrence of a jaundice; And monitoring of the mother whose milky ascent and psychological feelings. In March 2014, the HAS published new recommendations on maternity leave arrangements for the "mother - newborn" couple, the organization of postpartum follow - up for the mother and pediatric follow - up for the newborn. The HAS then defines so-called "optimal" conditions for so-called "standard" outputs, with 9 criteria to respect respectively for the mother and the newborn. If the mother-to-newborn couple respects these so-called optimal conditions and is eligible according to the respective criteria, the latter leaves at home after 72 hours and before 96 hours for an AVB and after 96 completed hours and Before 120 hours for caesarean delivery. As no pediatric discharge was done in the afternoons at the maternity hospital of Amiens, an arbitrary choice was made to allow a "standard" release to the "mother-newborn" couple only if the child was born between 00H00 and 11H59 so that his clinical examination of exit is carried out at 72 hours of the birth as recommended by the recommendations of the HAS. These recommendations being recent (2014), no study has studied the impact and consequences on the triad "father / mother-newborn" of these exits including the occurrence of possible complications or events: re-hospitalizations again The early termination of breastfeeding, and whether the follow-up procedures advocated by the HAS are being followed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 30, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

2.7 years

First QC Date

April 4, 2017

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The occurrence of complications in the first month of life in the "mother-newborn" couple.

    1 month

Study Arms (2)

Standard output

OTHER
Other: To study the absence of increased complications and events occurring in the "mother-newborn"

Non standard output

OTHER
Other: To study the absence of increased complications and events occurring in the "mother-newborn"

Interventions

To study the absence of increased complications and events occurring in the "mother-newborn" couple who made a "standard" exit compared to the "mother-newborn" couples who had benefited from an extra day of " Hospitalization in maternity.

Non standard outputStandard output

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be taken care of in the Maternity Department of the Amiens-Picardie University Hospital.
  • Parents' agreement
  • Mother and Newborn who meet the eligibility criteria of the HAS for a "standard" exit.
  • Mother :
  • \. Absence of a situation of psychological, social vulnerability, behaviors of addiction and severe dependencies
  • \. Adequate family and / or social support
  • \. Absence of chronic ill-balanced pathology
  • \. Absence of complications or pathologies requiring observation or continuous medical treatment
  • \. Absence of haemorrhage of the delivery, this one was checked and treated (if necessary)
  • \. Absence of active infection or signs of infection
  • \. Absence of thromboembolic signs
  • \. Controlled Pain
  • \. Satisfactory mother-child interactions
  • Child:
  • \. Newborn at term ≥ 37 weeks of amenorrhea, singleton and eutroph
  • +8 more criteria

You may not qualify if:

  • Patient not speaking French
  • Patient who does not meet the HAS criteria: newborn or ineligible mother (minor mother, non-singleton birth)
  • Assumption in another department than the Maternity department of the CHU Amiens-Picardie.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 14, 2017

Study Start

March 30, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations