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NCT04443205 Clinical Trial

Relevance of Ultrasound Screening for Foetal Macrosomia

Pregnancy Clinical Trial

— USmacro  

Official title:
Relevance of Ultrasound Screening for Foetal Macrosomia and Description of Its Management in Champagne-Ardenne

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04443205
Other study ID # PO20090
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2020
Est. completion date December 2021

Study information
Verified date June 2020
Source CHU de Reims
Contact Uzma ISHAQUE
Phone 03 10 73 62 88
Email uishaque@chu-reims.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Management of fetal macrosomia is based on a suspicion of macrosomia (no certainty before birth). This management is an artificial induction of labour for an earlier delivery and therefore a lower fetal weight gain. Several studies have already shown that ultrasound performed during the third trimester of pregnancy was not a perfect tool for this screening.

Description:

The aim of the study is to describe management of women whose child is macrosomal but has not been screened g using ultrasound during the third trimester of pregnancy.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 3000
Est. completion date December 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion criteria : Patients (consecutive inclusions) :

Women pregnant Women followed in the gynaecology and obstetrics department of the CHU of Reims, the CHG of Charleville Mézières or the CHG of Chalons en Champagne.

Women for which the delivery is planned in the gynaecology and obstetrics department of the Reims University Hospital, the Charleville Mézières General Hospital or the Chalons en Champagne General Hospital.

Non-inclusion criteria Women without ultrasound dating scan in the first trimester. Women having a contraindication to labour or vaginal delivery Women with a scarred uterus Women having a history of shoulder dystocia or obstetric trauma Women having a history of urinary or fecal incontinence Women having a history of bad birth experience with high psychological impact Women with maternal pathologies (excluding gestational diabetes) Women whose fetus is breech Women with twin pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Data record
Data record

Locations
Country Name City State
France Damien JOLLY Reims

Sponsors (1)
Lead Sponsor Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Foetal macrosomia estimated weight above the 90th percentile of the curves of the French College of Fetal Ultrasound during the third trimester ultrasound Baseline
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