Evaluating placental markers in pregnant women with and without antiphospholipid syndrome

Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

This study is trying to see if certain markers in the blood can help predict the risk of preeclampsia in pregnant women with antiphospholipid syndrome compared to those without it.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: IRCCS San Raffaele (Academic / other)
• Locations: 1 site (Milan)
• Trial ID: NCT05786235 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the predictive ability of placental angiogenesis markers for the risk of preeclampsia in pregnant women diagnosed with primary antiphospholipid syndrome (APS). It will involve two groups: one consisting of women with primary APS and another of women without APS, both aged 18 to 45 years. The study will measure levels of sFlt-1 and PlGF in maternal serum during each trimester of pregnancy to establish reference intervals specific to women affected by primary APS. Data collection will include both epidemiological information and biological samples.

Who should consider this trial

Good fit: Ideal candidates for this study are pregnant women aged 18 to 45, either diagnosed with primary APS or without APS but with a history of at least one full-term pregnancy.

Not a fit: Patients with chronic gestational pathologies or previous thrombotic events may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the prediction and management of preeclampsia in pregnant women with primary APS.

How similar studies have performed: While this approach is focused on a specific patient population, similar studies have shown promise in using placental markers to predict pregnancy complications.

Eligibility criteria

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:

* 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

Where this trial is running

Milan

• San Raffaele Hospital — Milan, Italy (Recruiting)

Study contacts

• Study coordinator: Patrizia Rovere Querini

Conditions Preeclampsia; Immunologic Disease; Antiphospholipid Antibody Syndrome Primary; Pregnancy Complications; Pregnancy, High Risk; Rheumatic Diseases