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

NCT ID: NCT03114930

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-30

Study Completion Date

2018-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mother-Child Relations Maternity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard output

Group Type OTHER

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

Intervention Type OTHER

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 output

Group Type OTHER

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

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 :

* 1\. Absence of a situation of psychological, social vulnerability, behaviors of addiction and severe dependencies
* 2\. Adequate family and / or social support
* 3\. Absence of chronic ill-balanced pathology
* 4\. Absence of complications or pathologies requiring observation or continuous medical treatment
* 5\. Absence of haemorrhage of the delivery, this one was checked and treated (if necessary)
* 6\. Absence of active infection or signs of infection
* 7\. Absence of thromboembolic signs
* 8\. Controlled Pain
* 9\. Satisfactory mother-child interactions

Child:

* 1\. Newborn at term ≥ 37 weeks of amenorrhea, singleton and eutroph
* 2\. Normal clinical examination performed imperatively 48 hours after birth and before discharge
* 3\. Axillary temperature between 36 and 37 ° C or central between 36.5 and 37.5 ° C
* 4\. Established feeding (if breastfeeding: observation of at least 2 feeds ensuring effective transfer of colostrum / milk recognized by the mother), urination and spontaneous stool emissions, established transit
* 5\. Weight loss \<8% of birth weight
* 6\. Absence of jaundice requiring phototherapy according to the therapeutic indication curve and measurement of transcutaneous and / or blood bilirubin at the output referred to the nomogram (low risk and low intermediate risk only)
* 7\. Lack of clinical or paraclinical evidence for infection; If risk factors of infection: recovered and negative biological and bacteriological samples
* 8\. Planned neonatal screening and traceability
* 9\. Post-partum follow-up after the organized event: an appointment with a referral professional within 48 hours following the exit or even in the week

Exclusion Criteria

* 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Amiens Picardie

Amiens, Picardie, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI2015_843_0023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.