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
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Fetal Macrosomia
• Pregnancy

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