NCT05786235 Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome
| NCT ID | NCT05786235 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Preeclampsia |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-12-06 |
| Primary Completion | 2025-12-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-12-06 with a primary completion date of 2025-12-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05786235 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05786235 currently recruiting?
Yes, NCT05786235 is actively recruiting participants. Contact the research team at rovere.patrizia@hsr.it for enrollment information.
Where is the NCT05786235 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05786235 clinical trial?
NCT05786235 is sponsored by IRCCS San Raffaele. The trial plans to enroll 60 participants.