Intrauterine Growth RestrictionANGIOPAGNCT05151289
Diagnostic Value of sFlt-1/PlGF Ratio for the Etiology of Intra Uterine Growth Restriction - ANGIOPAG
A study testing Blood test at time of inclusion for sFlt-1/PlGF ratio, Follow-up blood test 2 to 4 weeks after inclusion and Placenta analysis for all included patients, even in case of normal birthweight in people with Intrauterine Growth Restriction and Fetal Growth Restriction (FGR), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main aim of this project is to determine the Placental Growth Factor and Vascular Endothelial Growth Factor ratio's performance (sFlt-1/PlGF) for the etiological diagnosis of vascular Intrauterine growth restriction (IUGR) compared to a non-vascular IUGR. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intrauterine Growth Restriction, Fetal Growth Restriction (FGR)
- What is being tested?
- Blood test at time of inclusion for sFlt-1/PlGF ratio, Follow-up blood test 2 to 4 weeks after inclusion and Placenta analysis for all included patients, even in case of normal birthweight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2020to 29 Jan 2024
- Phase
- Interventional
- 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
Who may be able to join
- > 18 years old
- Singleton pregnancy
- Date of conception evaluated by ultrasound < 14 WG
- Consulting in one of the 3 participating centers for IUGR
- Estimated fetal weight < 5th centile (according to Hadlock 3 et CFEF)
- Between 22+0 WG et 34+6 WG
Who cannot join
- Major birth defect diagnosed at time of inclusion
- Abnormality of caryotype known at time of inclusion
- Confirmed preeclampsia at time of inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of sFlt-1/PlGF Ratio for the Etiology of Intra Uterine Growth Restriction
The main aim of this project is to determine the Placental Growth Factor and Vascular Endothelial Growth Factor ratio's performance (sFlt-1/PlGF) for the etiological diagnosis of vascular Intrauterine growth restriction (IUGR) compared to a non-vascular IUGR.
Read the detailed description
Intra-uterine growth restriction is one of the most frequent cause of consultation in prenatal diagnosis centers. Suspected Intrauterine growth restriction (IUGR) concerns 5.4% of pregnancies. Prognosis and management of IUGR depends on its etiology. It has been estimated that 80 to 90% of IUGR have a vascular cause, 5-15% an infectious cause and 2 to 5% chromosomal or genetic cause. More recently, a meta-analysis has shown that among 874 IUGR fetuses for whom amniocentesis was performed, anomaly of caryotype or comparative genomic hybridization array was reported for 6%. In case of vascular IUGR, amniocentesis is not indicated and close surveillance of mother and fetus is organized.
The diagnosis of vascular IUGR is most often confirmed after birth with placental histology. Before birth, the diagnosis of vascular IUGR is presumptive, and based on gestational age at diagnosis, quantity of amniotic fluid, end dopplers of umbilical artery and uterine arteries. The argument considered as most specific of vascular IUGR is the doppler of uterine arteries, however it has been shown that sensitivity of this test is weak : abnormal uterine arteries is reported in only 40% of fetuses with vasculat IUGR according to placenta pathology.
Biochemical markers Placental Growth Factor and Vascular Endothelial Growth Factor (sFlt1 and PlGF) have shown their prognostic value on the occurrence of preeclampsia. They are both associated to the delay until occurrence of preeclampsia and to the delay before extraction in case of IUGR. As diagnostic tool in IUGR, only two studies have investigated their value : the PlGF/sFlt-1 ratio identified 7 patients among 10 with abnormal placental pathology, and low PlGF value is associated with abnormal placental pathology among 122 cases of IUGR, however this study did not specify sensitivity and specificity values. A reliable and reproductible marker that could orient practitioners towards the need to propose amniocentesis at diagnosis of IUGR is therefore important to develop.
The main objective of ANGIOPAG is to determine the sFlt-1/PlGF ratio's performance for the etiological diagnosis of vascular IUGR compared to a non-vascular IUGR.
To reach this goal, ANGIOPAG is a diagnostic, multicenter, non-randomized study. It will be performed on 152 pregnant women over 18 with a term between 22and 34 +6 Weeks of Gestation (WG), consulting in participating centers for IUGR. For the research, a blood test will be carried, at the inclusion and 2 to 4 weeks after, to determine sFLT-1 and PlGF. All included patients'placenta will be analyzed, even in case of a child normal birth weight.
- Being tested
- Blood test at time of inclusion for sFlt-1/PlGF ratio, Follow-up blood test 2 to 4 weeks after inclusion, Placenta analysis for all included patients, even in case of normal birthweight
- Keywords
- sFlt1, PlGF, IUGR, intrauterine growth restriction, fetal growth restriction
- 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.
Blood test at time of inclusion for sFlt-1/PlGF ratioBiological
As part of the research, a blood sample is taken to measure the sFLT-1 and PlGF ratio at the inclusion visit.
Follow-up blood test 2 to 4 weeks after inclusionBiological
As part of the research, a blood sample is taken to measure the sFLT-1 and PlGF ratio at the follow-up visit (about 2-4 weeks after inclusion). This second sample is not mandatory for the evaluation of the study's main endpoint.
Placenta analysis for all included patients, even in case of normal birthweightDiagnostic test
After delivery, the placenta of each included patient is sent to anatomo-pathology (even in case of normal weight of the baby at birth). An anatomopathologist referent, designated for the study in each center, performs an analysis (aware of the clinic but not of the sFLT-1/PlGF ratio results), according to the benchmark criteria grid. Local analysis will classify the placenta as "vascular IUGR" or "nonvascular IUGR".
| Study group | Role | What they receive |
|---|---|---|
| Patients consulting in one of the participating centers for intra uterine growth restriction. | Experimental | All included patients Receives: Biological: Blood test at time of inclusion for sFlt-1/PlGF ratio; Biological: Follow-up blood test 2 to 4 weeks after inclusion; Diagnostic Test: Placenta analysis for all included patients, even in case of normal birthweight |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the PlGF / sFlt-1 ratio and placental lesions to confirm the diagnosis of vascular intrauterine growth retardation
The etiological diagnosis will be confirmed as vascular if characteristic lesions are identified on placental analysis. Lesions of maternal vascular malperfusion have been described and are those used in scientific literature. These characteristics are placental infarcts, decidual arteriopathy, and villous hypoplasia.
Measured: 34+6 Weeks of Gestation
Secondary outcomes (7)
Delay between inclusion and birth
Delay between inclusion and birth
Measured: 21 weeks after inclusion
Occurrence of preeclampsia
Occurrence of preeclampsia
Measured: 21 weeks after inclusion
Gestational age at birth
Gestational age at birth
Measured: maximum 21 weeks after inclusion
Birth weight
Birth weight
Measured: maximum 21 weeks after inclusion
Newborn evaluation (presence of birth defects)
Newborn evaluation (presence of birth defects)
Measured: maximum 21 weeks after inclusion
Rate of transfers to intensive care unit
Rate of transfers to intensive care unit
Measured: maximum 21 weeks after inclusion
Rate of death of babies
Rate of death of babies
Measured: maximum 21 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start8 Jan 2020
- Primary completion29 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients consulting in one of the participating centers for intra uterine growth restriction.
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanne Sibiude, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151289
- Sponsor's protocol ID
- APHP190472
- Other IDs
- 2019-A01116-51
- Acronym
- ANGIOPAG
- Status last verified
- Jul 2026
- First submitted
- 11 Oct 2021
- Last updated
- 12 Aug 2026
- 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 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of sFlt-1/PlGF Ratio for the Etiology of Intra Uterine Growth Restriction
- ClinicalTrials.gov ID
- NCT05151289
- Acronym / sponsor ID
- ANGIOPAG / APHP190472
- Keywords
- sFlt1, PlGF, IUGR, intrauterine growth restriction, fetal growth restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Jan 2020 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 9 Dec 2021 (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 main aim of this project is to determine the Placental Growth Factor and Vascular Endothelial Growth Factor ratio's performance (sFlt-1/PlGF) for the etiological diagnosis of vascular Intrauterine growth restriction (IUGR) compared to a non-vascular IUGR.
Detailed description
Intra-uterine growth restriction is one of the most frequent cause of consultation in prenatal diagnosis centers. Suspected Intrauterine growth restriction (IUGR) concerns 5.4% of pregnancies. Prognosis and management of IUGR depends on its etiology. It has been estimated that 80 to 90% of IUGR have a vascular cause, 5-15% an infectious cause and 2 to 5% chromosomal or genetic cause. More recently, a meta-analysis has shown that among 874 IUGR fetuses for whom amniocentesis was performed, anomaly of caryotype or comparative genomic hybridization array was reported for 6%. In case of vascular IUGR, amniocentesis is not indicated and close surveillance of mother and fetus is organized.
The diagnosis of vascular IUGR is most often confirmed after birth with placental histology. Before birth, the diagnosis of vascular IUGR is presumptive, and based on gestational age at diagnosis, quantity of amniotic fluid, end dopplers of umbilical artery and uterine arteries. The argument considered as most specific of vascular IUGR is the doppler of uterine arteries, however it has been shown that sensitivity of this test is weak : abnormal uterine arteries is reported in only 40% of fetuses with vasculat IUGR according to placenta pathology.
Biochemical markers Placental Growth Factor and Vascular Endothelial Growth Factor (sFlt1 and PlGF) have shown their prognostic value on the occurrence of preeclampsia. They are both associated to the delay until occurrence of preeclampsia and to the delay before extraction in case of IUGR. As diagnostic tool in IUGR, only two studies have investigated their value : the PlGF/sFlt-1 ratio identified 7 patients among 10 with abnormal placental pathology, and low PlGF value is associated with abnormal placental pathology among 122 cases of IUGR, however this study did not specify sensitivity and specificity values. A reliable and reproductible marker that could orient practitioners towards the need to propose amniocentesis at diagnosis of IUGR is therefore important to develop.
The main objective of ANGIOPAG is to determine the sFlt-1/PlGF ratio's performance for the etiological diagnosis of vascular IUGR compared to a non-vascular IUGR.
To reach this goal, ANGIOPAG is a diagnostic, multicenter, non-randomized study. It will be performed on 152 pregnant women over 18 with a term between 22and 34 +6 Weeks of Gestation (WG), consulting in participating centers for IUGR. For the research, a blood test will be carried, at the inclusion and 2 to 4 weeks after, to determine sFLT-1 and PlGF. All included patients'placenta will be analyzed, even in case of a child normal birth weight.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients consulting in one of the participating centers for intra uterine growth restriction.
| Arm | Type | Receives |
|---|---|---|
| Patients consulting in one of the participating centers for intra uterine growth restriction. | Experimental | Biological: Blood test at time of inclusion for sFlt-1/PlGF ratio, Biological: Follow-up blood test 2 to 4 weeks after inclusion, Diagnostic Test: Placenta analysis for all included patients, even in case of normal birthweightAll included patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 18 years old
- Singleton pregnancy
- Date of conception evaluated by ultrasound < 14 WG
- Consulting in one of the 3 participating centers for IUGR
- Estimated fetal weight < 5th centile (according to Hadlock 3 et CFEF)
Key exclusion criteria (3 listed)
- Major birth defect diagnosed at time of inclusion
- Abnormality of caryotype known at time of inclusion
- Confirmed preeclampsia at time of inclusion
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 |
|---|---|---|
| Blood test at time of inclusion for sFlt-1/PlGF ratioAs part of the research, a blood sample is taken to measure the sFLT-1 and PlGF ratio at the inclusion visit. | Biological | Patients consulting in one of the participating centers for intra uterine growth restriction. |
| Follow-up blood test 2 to 4 weeks after inclusionAs part of the research, a blood sample is taken to measure the sFLT-1 and PlGF ratio at the follow-up visit (about 2-4 weeks after inclusion). This second sample is not mandatory for the evaluation of the study's main endpoint. | Biological | Patients consulting in one of the participating centers for intra uterine growth restriction. |
| Placenta analysis for all included patients, even in case of normal birthweightAfter delivery, the placenta of each included patient is sent to anatomo-pathology (even in case of normal weight of the baby at birth). An anatomopathologist referent, designated for the study in each center, performs an analysis (aware of the clinic but not of the sFLT-1/PlGF ratio results), according to the benchmark criteria grid. Local analysis will classify the placenta as "vascular IUGR" or "nonvascular IUGR". | Diagnostic test | Patients consulting in one of the participating centers for intra uterine growth restriction. |
Primary outcome
To compare the PlGF / sFlt-1 ratio and placental lesions to confirm the diagnosis of vascular intrauterine growth retardation
Time frame: 34+6 Weeks of Gestation
The etiological diagnosis will be confirmed as vascular if characteristic lesions are identified on placental analysis. Lesions of maternal vascular malperfusion have been described and are those used in scientific literature. These characteristics are placental infarcts, decidual arteriopathy, and villous hypoplasia.
7 secondary outcomes
Delay between inclusion and birth
Time frame: 21 weeks after inclusion
Occurrence of preeclampsia
Time frame: 21 weeks after inclusion
Gestational age at birth
Time frame: maximum 21 weeks after inclusion
Birth weight
Time frame: maximum 21 weeks after inclusion
Newborn evaluation (presence of birth defects)
Time frame: maximum 21 weeks after inclusion
Rate of transfers to intensive care unit
Time frame: maximum 21 weeks after inclusion
Rate of death of babies
Time frame: maximum 21 weeks after inclusion
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 12 Aug 2026.
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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.
Jeanne Sibiude, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test at time of inclusion for sFlt-1/PlGF ratio, Follow-up blood test 2 to 4 weeks after inclusion and Placenta analysis for all included patients, even in case of normal birthweight in people with Intrauterine Growth Restriction and Fetal Growth Restriction (FGR), run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 3 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 12 Aug 2026. 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?
To compare the PlGF / sFlt-1 ratio and placental lesions to confirm the diagnosis of vascular intrauterine growth retardation (time frame: 34+6 Weeks of Gestation). 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 12 Aug 2026.