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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03295123
Other study ID # 2017-A00330-53
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 3, 2017
Est. completion date August 31, 2017

Study information

Verified date February 2023
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to evaluate the impact of denial pregnancy on children's health ( anthropometric data, psychomotor development , disease) at different age of evaluation ( at birth, 9 months, 24 months and between 2 and 6 years post natal age). The hypothesis is the denial of pregnancy may have repercussions on children's outcome.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date August 31, 2017
Est. primary completion date August 1, 2017
Accepts healthy volunteers
Gender All
Age group 1 Day to 8 Years
Eligibility Inclusion Criteria: - Child born after denial of pregnancy - Child born at term ( > 37 weeks of gestation) - Born between the 1st january 2009 and the 30th june 2015 at Maternité Regionale de Nancy Exclusion Criteria: - Mother's opposition - Child doesn't' living in France

Study Design


Intervention

Other:
phone interview with the mother
it's a telephone survey about children's health

Locations

Country Name City State
France Maternity Hospital CHRU Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary height (cm) infants height will be recorded from their health booklet and compared to reference chart log birth
Primary height (cm) infants height will be recorded from their health booklet and compared to reference chart log 9 months
Primary height (cm) infants height will be recorded from their health booklet and compared to reference chart log 24 months
Primary height (cm) infants height will be recorded from their health booklet and compared to reference chart log between 2 and 5 years
Primary weight (kg) infants weight will be recorded from their health booklet and compared to reference chart log birth
Primary weight (kg) infants weight will be recorded from their health booklet and compared to reference chart log 9 months
Primary weight (kg) infants weight will be recorded from their health booklet and compared to reference chart log 24 months
Primary weight (kg) infants weight will be recorded from their health booklet and compared to reference chart log between 2 and 5 years
Secondary psychomotor development infants psychomotor development items will be recorded from their health booklet and compared to reference chart log birth
Secondary psychomotor development infants psychomotor development items will be recorded from their health booklet and compared to reference chart log 9 months
Secondary psychomotor development infants psychomotor development items will be recorded from their health booklet and compared to reference chart log 24 months
Secondary psychomotor development infants psychomotor development items will be recorded from their health booklet and compared to reference chart log between 2 and 5 years
Secondary disease all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log birth
Secondary disease all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log 9 months
Secondary disease all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log 24 months
Secondary disease all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log between 2 and 5 years
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