IUGRNCT05551078
Thrombophilia Screening After Severe IUGR
An observational study of IUGR and Thrombophilia, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
This retrospective study aims to assess the input of thrombophilia screening in pregnant women with severe intra-uterine growth restricted babies. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- IUGR, Thrombophilia, Pregnancy Complications
- What is being tested?
- thrombophilia screening
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2022to 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: * Women over 18 years old * Pregnant women * IUGR defined by an EFW <3rd centile * IUGR before 25 GW
Who may be able to join
- Women over 18 years old
- Pregnant women
- IUGR defined by an EFW <3rd centile
- IUGR before 25 GW
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Matthieu Dap
Nancy, 54000
Matthieu Dap, 0630736896, m.dap@chru-nancy.fr
About this study
Official title: Thrombophilia Screening in Women After Severe IUGR
This retrospective study aims to assess the input of thrombophilia screening in pregnant women with severe intra-uterine growth restricted babies.
- Conditions
- IUGR, Thrombophilia, Pregnancy Complications
- Being tested
- thrombophilia screening
- Medical subject headings
- Thrombophilia, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thrombophilia screeningBiological
In the IUGR group systematic thrombophilia screening had already been performed.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with severe IUGR | Not described Receives: Biological: thrombophilia screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of positive's thrombophilia screening
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start15 Sep 2022
- Primary completionOct 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IUGRStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551078
- Sponsor's protocol ID
- 2022PI102
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombophilia Screening in Women After Severe IUGR
- ClinicalTrials.gov ID
- NCT05551078
- Acronym / sponsor ID
- 2022PI102
- Conditions
- IUGR, Thrombophilia, Pregnancy Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 22 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.
This retrospective study aims to assess the input of thrombophilia screening in pregnant women with severe intra-uterine growth restricted babies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women with severe IUGR | – | Biological: thrombophilia screening |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Women over 18 years old * Pregnant women * IUGR defined by an EFW <3rd centile * IUGR before 25 GW
Key inclusion criteria (4 listed)
- Women over 18 years old
- Pregnant women
- IUGR defined by an EFW <3rd centile
- IUGR before 25 GW
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| thrombophilia screeningIn the IUGR group systematic thrombophilia screening had already been performed. | Biological | pregnant women with severe IUGR |
Primary outcome
Rate of positive's thrombophilia screening
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 IUGR and Thrombophilia, 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 4 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: status not confirmed, as of the sponsor's last update on 22 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of positive's thrombophilia screening (time frame: 5 years). 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 22 Sep 2022.