Newborn in Helathy Birthroom: Assessment of Pratical Home and Mother Lived

Delivery Clinical Trial

— EPAVM  

Official title:

Newborn in Helathy Birthroom: Assessment of Pratical Home and Mother Lived

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02827019
• Other study ID #: EPAVM
• Status: Completed
• Start date: January 2015
• Est. completion date: February 28, 2015

Study information

• Verified date: August 2018
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: February 28, 2015
• Est. primary completion date: February 28, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 11 Days

Eligibility

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

Related Conditions & MeSH terms

• Delivery
• Motherhood
• Newborns

Intervention

Other:
• questionnaire
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

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of routine care	Will be considered as routine care: weighing, measurement, toilet or review	within the first 11 days life
Secondary	Number of realization of a levy	for gastric fluid or blood	within the first 11 days life
Secondary	Number of times that the Child was warming		within the first 11 days life
Secondary	Number of Clinical monitoring of the child		within the first 11 days life
Secondary	Number of care provided to the mother	Number and description of care provided to the mother	within the first 11 days life