USmacro: Relevance of Ultrasound Screening for Foetal Macrosomia

Sponsor

CHU de Reims (Other)

Overall Status

Unknown status

CT.gov ID

NCT04443205

Collaborator

(none)

3,000

Enrollment

Location

Anticipated Duration (Months)

166.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Other: Data record

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
no macrosomy pregnant women whose child is not macrosomal	Other: Data record Data record
screened macrosomy pregnant women whose child is macrosomal and have been screened g using ultrasound during the third trimester of pregnancy	Other: Data record Data record
no screened macrosomy pregnant women whose child is macrosomal and havenot been screened g using ultrasound during the third trimester of pregnancy	Other: Data record Data record

Arm

Intervention/Treatment

no macrosomy

pregnant women whose child is not macrosomal

Other: Data record

Data record

screened macrosomy

pregnant women whose child is macrosomal and have been screened g using ultrasound during the third trimester of pregnancy

Other: Data record

Data record

no screened macrosomy

pregnant women whose child is macrosomal and havenot been screened g using ultrasound during the third trimester of pregnancy

Other: Data record

Data record

Outcome Measures

Primary Outcome Measures

Foetal macrosomia [Baseline]
estimated weight above the 90th percentile of the curves of the French College of Fetal Ultrasound during the third trimester ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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