Fetal Growth RetardationNCT05696223
Doppler at the Diagnosis in Predicting Perinatal Outcomes in Early and Late-onset Fetal Growth Restriction
An observational study of Fetal Growth Retardation, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
When a FGR is diagnose, the challenge in his monitoring is to assess the benefit-risk balance between continuing the pregnancy in order to limit complications related to prematurity and birth in order to minimize any risk of fetal death in utero. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Ultrasound
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 1 Jan 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 to 50 years
- Women only
- Adult
Study population: All the FGR of antenatal diagnosis, who were confirmed by an ultrasound made by a referring Doctor and involved in a specific management for FGR, during this period of 2 years were included
Who may be able to join
- Fetal growth restriction of antenatal diagnosis
Who cannot join
- Twin pregnancies, non-isolated IUGR, post-natal diagnosis of FGR and incomplete records
Trial locations and contacts
1 site in 1 country.
France1 site
Maternite Regionale et Universitaire de Nancy
Nancy, Meurthe-et-moselle, 54000
About this study
When a FGR is diagnose, the challenge in his monitoring is to assess the benefit-risk balance between continuing the pregnancy in order to limit complications related to prematurity and birth in order to minimize any risk of fetal death in utero. By able to know the characteristics of fetal deteriorations and its relationship with fetal and neonatal outcomes could be a thankful help in this decision. The placental insufficiency is by far the most common cause of FGR (32)(miller 2008). This effect can be documented thanks to ultrasound examinations to study fetal growth and Doppler of umbilical arteries for the placenta, the middle cerebral artery for the brain perfusion and the Ductus Venosus for the cardiac effects of placental dysfunction. The apparition of Doppler abnormalities suggests a deterioration of the disease and leads to several changes in clinical FGR management. Nevertheless, at this time, very few studies allow us to predict the time util the degradation and their impact on perinatal outcomes.
The primary aim of this study was to evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies. The secondary aim was to evaluate the performance of Doppler performed at any time during pregnancy and studied independently in predicting outcome of pregnancies
- Conditions
- Fetal Growth Retardation
- Being tested
- Ultrasound
- Keywords
- Fetal Growth Retardation, Doppler, perinatale outcome
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Doppler mesure
| Study group | Role | What they receive |
|---|---|---|
| Early fetal growth restriction | Fetal growth restriction diagnosed before 32 SA Receives: Other: Ultrasound | |
| Late fetal growth restriction | Fetal growth restriction diagnosed after 32 SA Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies
Measured: during pregnancy (6 month per patient maximum)
Secondary outcomes (1)
evaluate the performance of Doppler performed at any time during pregnancy and studied independently in predicting outcome of pregnancies
Measured: during pregnancy (6 month per patient maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Jun 2022
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOURNIER Mathilde, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696223
- Sponsor's protocol ID
- 2022PI187-343
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler at the Diagnosis in Predicting Perinatal Outcomes in Early and Late-onset Fetal Growth Restriction
- ClinicalTrials.gov ID
- NCT05696223
- Acronym / sponsor ID
- 2022PI187-343
- Conditions
- Fetal Growth Retardation
- Keywords
- Fetal Growth Retardation, Doppler, perinatale outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 25 Jan 2023 (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.
When a FGR is diagnose, the challenge in his monitoring is to assess the benefit-risk balance between continuing the pregnancy in order to limit complications related to prematurity and birth in order to minimize any risk of fetal death in utero. By able to know the characteristics of fetal deteriorations and its relationship with fetal and neonatal outcomes could be a thankful help in this decision. The placental insufficiency is by far the most common cause of FGR (32)(miller 2008). This effect can be documented thanks to ultrasound examinations to study fetal growth and Doppler of umbilical arteries for the placenta, the middle cerebral artery for the brain perfusion and the Ductus Venosus for the cardiac effects of placental dysfunction. The apparition of Doppler abnormalities suggests a deterioration of the disease and leads to several changes in clinical FGR management. Nevertheless, at this time, very few studies allow us to predict the time util the degradation and their impact on perinatal outcomes.
The primary aim of this study was to evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies. The secondary aim was to evaluate the performance of Doppler performed at any time during pregnancy and studied independently in predicting outcome of pregnancies
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early fetal growth restriction | – | Other: UltrasoundFetal growth restriction diagnosed before 32 SA |
| Late fetal growth restriction | – | Other: UltrasoundFetal growth restriction diagnosed after 32 SA |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All the FGR of antenatal diagnosis, who were confirmed by an ultrasound made by a referring Doctor and involved in a specific management for FGR, during this period of 2 years were included
Key inclusion criteria (1 listed)
- Fetal growth restriction of antenatal diagnosis
Key exclusion criteria (1 listed)
- Twin pregnancies, non-isolated IUGR, post-natal diagnosis of FGR and incomplete records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundDoppler mesure | Other | Early fetal growth restriction, Late fetal growth restriction |
Primary outcome
evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies
Time frame: during pregnancy (6 month per patient maximum)
1 secondary outcome
evaluate the performance of Doppler performed at any time during pregnancy and studied independently in predicting outcome of pregnancies
Time frame: during pregnancy (6 month per patient maximum)
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 25 Jan 2023.
- Individual participant dataSharing planned: No
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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 Growth Retardation, run by Central Hospital, Nancy, 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 1 inclusion and 1 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 25 Jan 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?
evaluate the performance of the Doppler at the time of diagnosis in predicting the outcome of pregnancies (time frame: during pregnancy (6 month per patient maximum)). 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 25 Jan 2023.