CGH-array in Prenatal Diagnosis of Isolated Severe and Early Intra-uterine Growth Restriction

January 25, 2021 updated by: Matthieu DAP, Central Hospital, Nancy, France
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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).

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • associated IUGR (with other abnormalities during prenatal screening)

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
Time Frame
rate of abnormal CGH-array in the groupe "severe and early" UGR
Time Frame: one-time (at the time of the analysis)
one-time (at the time of the analysis)

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 (ANTICIPATED)

January 31, 2021

Primary Completion (ANTICIPATED)

March 15, 2021

Study Completion (ANTICIPATED)

November 30, 2021

Study Registration Dates

First Submitted

January 25, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (ACTUAL)

January 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI007

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.

Clinical Trials on Genetic Disease

Clinical Trials on CGH array analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe