NCT03295123

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

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

May 3, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2017

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

July 27, 2017

Last Update Submit

February 13, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • height (cm)

    infants height will be recorded from their health booklet and compared to reference chart log

    birth

  • height (cm)

    infants height will be recorded from their health booklet and compared to reference chart log

    9 months

  • height (cm)

    infants height will be recorded from their health booklet and compared to reference chart log

    24 months

  • height (cm)

    infants height will be recorded from their health booklet and compared to reference chart log

    between 2 and 5 years

  • weight (kg)

    infants weight will be recorded from their health booklet and compared to reference chart log

    birth

  • weight (kg)

    infants weight will be recorded from their health booklet and compared to reference chart log

    9 months

  • weight (kg)

    infants weight will be recorded from their health booklet and compared to reference chart log

    24 months

  • weight (kg)

    infants weight will be recorded from their health booklet and compared to reference chart log

    between 2 and 5 years

Secondary Outcomes (8)

  • psychomotor development

    birth

  • psychomotor development

    9 months

  • psychomotor development

    24 months

  • psychomotor development

    between 2 and 5 years

  • disease

    birth

  • +3 more secondary outcomes

Interventions

it's a telephone survey about children's health

Eligibility Criteria

Age1 Day - 8 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Every children born at term after denial of pregnancy

You may qualify if:

  • 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

You may not qualify if:

  • Mother's opposition
  • Child doesn't' living in France

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity Hospital CHRU

Nancy, 54035, France

Location

MeSH Terms

Conditions

Rejection, PsychologyDisease

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 27, 2017

First Posted

September 27, 2017

Study Start

May 3, 2017

Primary Completion

August 1, 2017

Study Completion

August 31, 2017

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations