- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02827019
Newborn in Helathy Birthroom: Assessment of Pratical Home and Mother Lived (EPAVM)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective of the study Evaluation of home practices of a healthy newborn in the delivery room: skin processing conditions skin, reasons for separation between mother and child and maternal felt appreciation.
Methodology :
DESIGN:
Study single-center observational descriptive, carried out over a period of 8 weeks during the months of January and February 2015 in the Maternity Our Lady of relief
Acquisition of data:
- From a survey conducted in 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 memories of parents. The questionnaire included a section on skin to skin layout with the newborn (information on skin to skin, original maturity), the output or not the child of the delivery room (reason given, period of separation , felt the mother), the conditions of return (naked or dressed, delivered or not skin to skin, conditions the first feeding), the place of the first examination of the newborn and the overall satisfaction of the mother.
The reasons for the release of children were classified as routine care (weight, measurements, toilet or exam), clinical monitoring of the Child (declogging, monitoring of respiratory discomfort or poor adaptation), warming the child, simple or complicated maternal care) and implementation of a levy (gastric, Rh, pH). The traceability of the reason for leaving the newborn in the delivery room was searched in the newborn monitoring sheet (production of a levy, the child's warming, clinical monitoring of the child) and in the medical record of the mother (complicated birthing suites with uterus bleeding or tearing).
- And from the collection of the passage of newborns in the "nursery" of the delivery room of 11 days. The collection form was filled by the auxiliary of the delivery room should note that with each pass of a newborn in the "nursery", the time of birth, time of arrival and departure and the main reason for the passage of the newborn in the "nursery." The reasons were categorized (routine care, achieving a levy, the child's warming, clinical monitoring of the child, the mother care).
Analysis: This is primarily a descriptive analysis. A comprehensive description of the sample was carried out by giving the frequencies of different categories for qualitative variables.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ile-de-France
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Paris, Ile-de-France, France, 75014
- Groupe hospitalier Paris saint Joseph
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Preterm (<37 weeks of gestation), hypotrophe (<10th cp)
- Born by caesarean section
- Poor adaptation to extra-uterine life
- Amniotic fluid meconium
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of routine care
Time Frame: within the first 11 days life
|
Will be considered as routine care: weighing, measurement, toilet or review
|
within the first 11 days life
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of realization of a levy
Time Frame: within the first 11 days life
|
for gastric fluid or blood
|
within the first 11 days life
|
|
Number of times that the Child was warming
Time Frame: within the first 11 days life
|
within the first 11 days life
|
|
|
Number of Clinical monitoring of the child
Time Frame: within the first 11 days life
|
within the first 11 days life
|
|
|
Number of care provided to the mother
Time Frame: within the first 11 days life
|
Number and description of care provided to the mother
|
within the first 11 days life
|
Collaborators and Investigators
Investigators
- Principal Investigator: TASSEAU Angelique, MD, Groupe hospitalier Paris saint Joseph
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EPAVM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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