PreeclampsiaNCT05786235
Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome
An observational study of Preeclampsia and Immunologic Disease, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS. To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Immunologic Disease, Antiphospholipid Antibody Syndrome Primary
- What is being tested?
- Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 6 Dec 2022to 6 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: At least 60 patients aged 18-45 years will be enrolled between the first and third trimester of gestation, specifically 40 pregnant patients with primary APS (Group 1) and 20 pregnant patients without APS (Group 2) followed at the outpatient clinics of Obstetrics and Pregnancy Pathology of the participating centers. All patients will be asked to sign an informed consent prior to the collection of data and biological material.
Who may be able to join
- Group 1
- Pregnant patients between the ages of 18 and 45 years.
- Diagnosis of primary APS, according to international classification criteria.
- Group 2
- Pregnant patients between the ages of 18 and 45 years.
- Patients with at least one previous full-term pregnancy.
- No diagnosis of APS, according to international classification criteria.
Who cannot join
- Group 1
- PMA pregnancies.
- Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
- Previous thrombotic event
- Chronic renal failure not related to AD
- Previous history of oncology
Show all 12Show fewer
- Group 2
- Pregnancy by PMA.
- Previous history of polyabortion and/or late pregnancy complications.
- Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
- Previous thrombotic event
- Previous history of oncology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
San Raffaele Hospital
Milan
Patrizia Rovere Querini, PhD,MD, +390226433065, rovere.patrizia@hsr.it
Valentina Canti, MD, +390226436095, canti.valentina@hsr.it
About this study
The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS.
To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM).
For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.
- Conditions
- Preeclampsia, Immunologic Disease, Antiphospholipid Antibody Syndrome Primary, Pregnancy Complications, Pregnancy, High Risk, Rheumatic Diseases
- Being tested
- Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)
- Medical subject headings
- Pre-Eclampsia, Immune System Diseases, Pregnancy Complications, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)Other
Patients will be enrolled in the study during the first trimester of gestation or later, if the diagnosis of APS is made during pregnancy followed by clinical practice. During the quarterly visits scheduled by clinical practice, the following will be collected relevant clinical information and the additional biological samples for analysis of serum levels of sFlt-1 and PlGF. A follow-up postpartum visit is scheduled by clinical practice at 6 weeks after completion of delivery.
Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)Other
Patients will be enrolled during the performance of prenatal diagnosis, routinely chosen by the patient, at which the relevant clinical information and the additional biological sample . Collection of biological material in the 2nd and 3rd TM of gestation will take place at occasion of the routinely scheduled ultrasound scans . A postpartum follow-up visit is scheduled by clinical practice at 6 weeks after the completion of delivery.
| Study group | Role | What they receive |
|---|---|---|
| pregnant patients with primary APS | Diagnosis of primary APS, according to international classification criteria Receives: Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood) | |
| pregnant patients who do not have APS | Patients with at least one previous full-term pregnancy No diagnosis of APS, according to international classification criteria Receives: Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy
To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM).
Measured: six month after the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start6 Dec 2022
- Primary completion6 Dec 2025 (estimated)
- Study completion6 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rovere Querini Patrizia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786235
- Sponsor's protocol ID
- APS_FLT1/PLGF
- Status last verified
- Jun 2025
- First submitted
- 15 Mar 2023
- Last updated
- 18 Jun 2025
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome
- ClinicalTrials.gov ID
- NCT05786235
- Acronym / sponsor ID
- APS_FLT1/PLGF
- Conditions
- Preeclampsia, Immunologic Disease, Antiphospholipid Antibody Syndrome Primary, Pregnancy Complications, Pregnancy, High Risk, Rheumatic Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 6 Dec 2025 (estimated)
- Study completion
- 6 Jun 2026 (estimated)
- First posted
- 27 Mar 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.
The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS.
To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM).
For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant patients with primary APS | – | Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)Diagnosis of primary APS, according to international classification criteria |
| pregnant patients who do not have APS | – | Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)Patients with at least one previous full-term pregnancy No diagnosis of APS, according to international classification criteria |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- At least 60 patients aged 18-45 years will be enrolled between the first and third trimester of gestation, specifically 40 pregnant patients with primary APS (Group 1) and 20 pregnant patients without APS (Group 2) followed at the outpatient clinics of Obstetrics and Pregnancy Pathology of the participating centers. All patients will be asked to sign an informed consent prior to the collection of data and biological material.
Key inclusion criteria (7 listed)
- Group 1
- Group 2
Key exclusion criteria (12 listed)
- Group 1
- Group 2
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 |
|---|---|---|
| Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)Patients will be enrolled in the study during the first trimester of gestation or later, if the diagnosis of APS is made during pregnancy followed by clinical practice. During the quarterly visits scheduled by clinical practice, the following will be collected relevant clinical information and the additional biological samples for analysis of serum levels of sFlt-1 and PlGF. A follow-up postpartum visit is scheduled by clinical practice at 6 weeks after completion of delivery. | Other | pregnant patients with primary APS |
| Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)Patients will be enrolled during the performance of prenatal diagnosis, routinely chosen by the patient, at which the relevant clinical information and the additional biological sample . Collection of biological material in the 2nd and 3rd TM of gestation will take place at occasion of the routinely scheduled ultrasound scans . A postpartum follow-up visit is scheduled by clinical practice at 6 weeks after the completion of delivery. | Other | pregnant patients who do not have APS |
Primary outcome
To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy
Time frame: six month after the end of the study
To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- 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.
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 Preeclampsia and Immunologic Disease, run by IRCCS San Raffaele at 1 site in Italy.
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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrizia Rovere Querini (+390226436095, rovere.patrizia@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy (time frame: six month after the end of the study). 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 18 Jun 2025.