Impact of Ultrasound Fetal Weight Estimation on Obstetrical Management and Maternal and Neonatal Outcomes

Fetal Weight Clinical Trial

— EPF  

Official title:

Impact of Ultrasound Fetal Weight Estimation on Obstetrical Management and Maternal and Neonatal Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530616
• Other study ID #: 8581
• Status: Completed
• Start date: May 13, 2022
• Est. completion date: October 13, 2023

Study information

• Verified date: November 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators wish to study the obstetrical data of pregnant women who had an ultrasound estimation of fetal weight and who delivered at the University Hospital of Strasbourg over the last 20 years. These retrospectively collected data are a valuable source of scientific information since they are "real life data", currently of growing interest in the scientific community, and have a large volume and quality due to the number of years included and the variety of information collected in the computerized media records. From this study, the investigators hope not only to better understand the consequences of ultrasound screening for fetal growth, but also to improve its accuracy and to develop useful models in obstetrical decision making in order to decrease maternal and neonatal morbidity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70000
• Est. completion date: October 13, 2023
• Est. primary completion date: September 13, 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Major subject (=18 years of age).
• Female and with a single pregnancy
• Subject having had an ultrasound follow-up at HUS between 01/01/2000 and 31/12/2021
• Subject who gave birth at HUS between 01/01/2000 and 12/31/2021
• Subject who does not object to the reuse of her data for scientific research purposes

Exclusion Criteria:

• Subject who has expressed opposition to the reuse of their data for scientific research purposes
• Multiple pregnancies
• Delivery before 24 weeks of amenorrhea
• Diagnosis of a malformative fetal pathology
• Diagnosis of fetal death in utero

Related Conditions & MeSH terms

• Body Weight
• Fetal Weight

Locations

Country	Name	City	State
France	Service de Gynécologie Obstétrique - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective study of maternal and neonatal clinical and ultrasound data for the development of an algorithm model useful in obstetrical decision making in order to decrease maternal and neonatal morbidity.		Files analysed retrospectively from January 01, 2000 to December 31, 2021 will be examined