ClinicalTrials.gg
CompletedNCT05530616EPFUpdated Nov 9, 2023

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

An observational study in Fetal Weight, sponsored by University Hospital, Strasbourg, France. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-09.

Sponsored by University Hospital, Strasbourg, France · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
70,000
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Fetal Weight

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Keywords

  • Fetal Weight
  • Ultrasound Fetal Weight
  • Obstetrical Management
  • Maternal Outcomes
  • Neonatal Outcomes
03

In context

Fetal Weight

17 studies on the registry are indexed under Fetal Weight; 7 are open to participants now.

Browse Fetal Weight studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
70,000 participants (actual)
Patient registry
No
06

What researchers measure

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.

    Time frame: Files analysed retrospectively from January 01, 2000 to December 31, 2021 will be examined

07

Study locations

1 site
  • Service de Gynécologie Obstétrique - CHU de Strasbourg - France
    Strasbourg, 67091, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2022 to primary completion in Sep 2023, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2022
First posted
Sep 7, 2022
StartActual
May 13, 2022
Primary completionActual
Sep 13, 2023
CompletionActual
Oct 13, 2023
Last update
Nov 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05530616
Responsible party
Sponsor
First posted
Sep 7, 2022
Start date
May 13, 2022
Primary completion
Sep 13, 2023
Completion
Oct 13, 2023
Last update
Nov 9, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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