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RecruitingNCT05786235Updated Jun 18, 2025

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

An observational study in Preeclampsia, Immunologic Disease and Antiphospholipid Antibody Syndrome Primary, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-18.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Dec 2022; still recruiting 3 years 11 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 45 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Preeclampsia
  • Immunologic Disease
  • Antiphospholipid Antibody Syndrome Primary
  • Pregnancy Complications
  • Pregnancy, High Risk
  • Rheumatic Diseases
03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 60 is below the median of 165 across 397 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.

Browse IRCCS San Raffaele studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Group 1

    1. Pregnant patients between the ages of 18 and 45 years.
    2. Diagnosis of primary APS, according to international classification criteria.

  • Group 2

    1. Pregnant patients between the ages of 18 and 45 years.
    2. Patients with at least one previous full-term pregnancy.
    3. No diagnosis of APS, according to international classification criteria.

Exclusion criteria

Exclusion Criteria:

  • Group 1

    1. PMA pregnancies.
    2. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
    3. Previous thrombotic event
    4. Chronic renal failure not related to AD
    5. Previous history of oncology

  • Group 2

    1. Pregnancy by PMA.
    2. Previous history of polyabortion and/or late pregnancy complications.
    3. Known chronic pathology in gestational period such as chronic essential hypertension, neurological pathology
    4. Previous thrombotic event
    5. Previous history of oncology
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • pregnant patients with primary APS

    Diagnosis of primary APS, according to international classification criteria

    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

    Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)

Interventions

  • OtherCollection 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.

  • OtherCollection 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: six month after the end of the study

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2022 (actual). Primary completion is estimated for Dec 2025, 36 months after the start.

Of 191 non-industry observational studies under Pre-Eclampsia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 56. This study's planned 36 months is above that.

Counting every sponsor, half of 200 studies reached it within 30 months; a quarter within 11 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 15, 2023
First posted
Mar 27, 2023
StartActual
Dec 6, 2022
Primary completionEst.
Dec 6, 2025
CompletionEst.
Jun 6, 2026
Last update
Jun 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05786235
Lead sponsor
IRCCS San Raffaele
Responsible party
Rovere Querini Patrizia (Associate Professor of Internal Medicine, Vita-Salute San Raffaele University Head physician, U.O. General Medicine and Continuity of Care, IRCCS San Raffaele Hospital, IRCCS San Raffaele) — Principal investigator
First posted
Mar 27, 2023
Start date
Dec 6, 2022
Primary completion
Dec 6, 2025 (estimated)
Completion
Jun 6, 2026 (estimated)
Last update
Jun 18, 2025

Study contacts

Patrizia Rovere Querini
Contact
rovere.patrizia@hsr.it
+390226436095
Valentina Canti
Contact
canti.valentina@hsr.it
+390226436095

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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