Fetal WeightEPFNCT05530616
Impact of Ultrasound Fetal Weight Estimation on Obstetrical Management and Maternal and Neonatal Outcomes
An observational study of Fetal Weight, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Weight
- How many people
- 70,000 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2022to 13 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie Obstétrique - CHU de Strasbourg - France
Strasbourg, 67091
About this study
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.
- Conditions
- Fetal Weight
- Keywords
- Fetal Weight, Ultrasound Fetal Weight, Obstetrical Management, Maternal Outcomes, Neonatal Outcomes
- Medical subject headings
- Fetal Weight
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Files analysed retrospectively from January 01, 2000 to December 31, 2021 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start13 May 2022
- Primary completion13 Sep 2023
- Study completion13 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal WeightStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530616
- Sponsor's protocol ID
- 8581
- Acronym
- EPF
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrasound Fetal Weight Estimation on Obstetrical Management and Maternal and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT05530616
- Acronym / sponsor ID
- EPF / 8581
- Conditions
- Fetal Weight
- Keywords
- Fetal Weight, Ultrasound Fetal Weight, Obstetrical Management, Maternal Outcomes, Neonatal Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70,000 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Weight, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.