NCT05530616

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.3 years

First QC Date

September 2, 2022

Last Update Submit

November 8, 2023

Conditions

Keywords

Fetal WeightUltrasound Fetal WeightObstetrical ManagementMaternal OutcomesNeonatal Outcomes

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major Female (≥18 years of age) with a single pregnancy having had an ultrasound follow-up at HUS between 01/01/2000 and 31/12/2021

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Gynécologie Obstétrique - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Fetal Weight

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

May 13, 2022

Primary Completion

September 13, 2023

Study Completion

October 13, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations