Outcome of Children Born After Pregnancy Denial (DENIGRO)

February 13, 2023 updated by: Jean-Michel HASCOET, Central Hospital, Nancy, France

Outcome Children Born After Pregnancy Denial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54035
        • Maternity Hospital CHRU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 8 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Every children born at term after denial of pregnancy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
height (cm)
Time Frame: birth
infants height will be recorded from their health booklet and compared to reference chart log
birth
height (cm)
Time Frame: 9 months
infants height will be recorded from their health booklet and compared to reference chart log
9 months
height (cm)
Time Frame: 24 months
infants height will be recorded from their health booklet and compared to reference chart log
24 months
height (cm)
Time Frame: between 2 and 5 years
infants height will be recorded from their health booklet and compared to reference chart log
between 2 and 5 years
weight (kg)
Time Frame: birth
infants weight will be recorded from their health booklet and compared to reference chart log
birth
weight (kg)
Time Frame: 9 months
infants weight will be recorded from their health booklet and compared to reference chart log
9 months
weight (kg)
Time Frame: 24 months
infants weight will be recorded from their health booklet and compared to reference chart log
24 months
weight (kg)
Time Frame: between 2 and 5 years
infants weight will be recorded from their health booklet and compared to reference chart log
between 2 and 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychomotor development
Time Frame: birth
infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
birth
psychomotor development
Time Frame: 9 months
infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
9 months
psychomotor development
Time Frame: 24 months
infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
24 months
psychomotor development
Time Frame: between 2 and 5 years
infants psychomotor development items will be recorded from their health booklet and compared to reference chart log
between 2 and 5 years
disease
Time Frame: birth
all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
birth
disease
Time Frame: 9 months
all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
9 months
disease
Time Frame: 24 months
all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
24 months
disease
Time Frame: between 2 and 5 years
all diseases which occured from birth will be recorded from their health booklet and compared to reference chart log
between 2 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2017

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

September 22, 2017

First Posted (Actual)

September 27, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-A00330-53

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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