NCT02827019

Brief Summary

Motherhood Our Lady of Good Help is from the 2006 merger of three hospitals, St. Joseph, Our Lady of Good Help and Saint-Michel. She was transferred to a new building in the heart of Paris Saint-Joseph Hospital Group website in March 2011. The premises of the birth room are spacious and nice. All delivery rooms are supposed to welcome the mother and child when the birth goes smoothly. There is a resuscitation room (called "Nursery") for newborns requiring medical care. But since the installation in the new building, the investigators had the impression that a number of children born without pathology futures and with good adaptation at birth passed through this room for no apparent medical reason. The investigators wanted to make an inventory of home practice healthy newborns in our maternity, evaluate the reasons for a possible separation and appreciate the feelings of mothers cope with this separation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

July 6, 2016

Last Update Submit

August 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of routine care

    Will be considered as routine care: weighing, measurement, toilet or review

    within the first 11 days life

Secondary Outcomes (4)

  • Number of realization of a levy

    within the first 11 days life

  • Number of times that the Child was warming

    within the first 11 days life

  • Number of Clinical monitoring of the child

    within the first 11 days life

  • Number of care provided to the mother

    within the first 11 days life

Interventions

a questionnaire made puerperium the 2nd day of life during the interview with the parents on the basis of a semi-structured interview about the progress of the birth and the immediate postpartum period using the memories of parents

Eligibility Criteria

Age1 Day - 11 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

mothers whose newborns meet the inclusion criteria. They are in good health before birth mothers in normal

You may qualify if:

  • Newborns at term (≥ 37 weeks of gestation), eutrophic (≥ 10th p)
  • Born vaginally
  • Good adaptation to extra-uterine life: breathe or scream, has good skin color, a good tone with an Apgar score ≥7
  • Absence of meconium amniotic fluid

You may not qualify if:

  • Preterm (\<37 weeks of gestation), hypotrophe (\<10th cp)
  • Born by caesarean section
  • Poor adaptation to extra-uterine life
  • Amniotic fluid meconium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • TASSEAU Angelique, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2016

First Posted

July 11, 2016

Study Start

January 1, 2015

Primary Completion

February 28, 2015

Study Completion

February 28, 2015

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations