Relevance of Ultrasound Screening for Foetal Macrosomia

NCT04443205 | Unknown

• 1 other identifier: PO20090
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Fetal Macrosomia; Ultrasound; Shoulder Dystocia; induction of labour; Cesarean

Outcome Measures

Primary Outcomes (1)

• Foetal macrosomia

  estimated weight above the 90th percentile of the curves of the French College of Fetal Ultrasound during the third trimester ultrasound

  Baseline

Study Arms (3)

no macrosomy

pregnant women whose child is not macrosomal

Other: 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

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

Interventions

Data record OTHER

Data record

no macrosomy; no screened macrosomy; screened macrosomy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• 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.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Fetal Macrosomia; Shoulder Dystocia

Interventions

Electronic Health Records

Condition Hierarchy (Ancestors)

Diabetes, Gestational; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Pregnancy in Diabetics; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Birth Weight; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dystocia; Obstetric Labor Complications

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Uzma ISHAQUE

CONTACT

03 10 73 62 88; uishaque@chu-reims.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 23, 2020
• Study Start: June 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 23, 2020

Record last verified: 2020-06

Locations

FR (1)