NCT04729361

Brief Summary

According to french recommandations for IUGR management we have to propose a CGH-array analysis if the IUGR is severe (bellow the 3rd percentile) and early (in the second trimester). However there is no data to support this point of view.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

January 31, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

January 25, 2021

Last Update Submit

January 25, 2021

Conditions

IUGRPrenatal DisorderGenetic Disease

Outcome Measures

Primary Outcomes (1)

  • rate of abnormal CGH-array in the groupe "severe and early" UGR

    one-time (at the time of the analysis)

Interventions

CGH array analysisGENETIC

CGH array analysis

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

fetus with an isolated intra-uterine growth restriction (IUGR) severe (bellow the third percentile on CFEF curves) and early (between 21 and 24 gestational weeks).

You may qualify if:

  • pregnant women
  • fetus with an isolated intra-uterine growth restriction (IUGR) severe (bellow the third percentile on CFEF curves) and early (between 21 and 24 gestational weeks).

You may not qualify if:

  • associated IUGR (with other abnormalities during prenatal screening)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor (MD)

Study Record Dates

First Submitted

January 25, 2021

First Posted

January 28, 2021

Study Start

January 31, 2021

Primary Completion

March 15, 2021

Study Completion

November 30, 2021

Last Updated

January 28, 2021

Record last verified: 2021-01