Study of the Prevalence of Complications Occurring in the Mother-newborn Couple During the First Month After Returning Home, Since the Introduction of Standard Outpatients (According to HAS 2014 Recommendations) at the Amiens-Picardie University Hospital
COMPLISTAN
1 other identifier
interventional
177
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Typical duration for not_applicable
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
Study Start
First participant enrolled
March 30, 2016
CompletedFirst Submitted
Initial submission to the registry
April 4, 2017
CompletedFirst Posted
Study publicly available on registry
April 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 19, 2025
November 1, 2025
2.7 years
April 4, 2017
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
OTHERNon standard output
OTHERInterventions
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.
Eligibility Criteria
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
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