Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome

• Sponsor: IRCCS San Raffaele (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05786235
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 42
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia; Immunologic Disease; Antiphospholipid Antibody Syndrome Primary; Pregnancy Complications; Pregnancy, High Risk; Rheumatic Diseases	Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood); Other: Collection of epidemiological and anamnestic data and collection of biological material (peripheral blood)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Patients Pregnant Women With or Without Primary Antiphospholipid Antibody Syndrome
• Actual Study Start Date: Dec 6, 2022
• Anticipated Primary Completion Date: Dec 6, 2025
• Anticipated Study Completion Date: Jun 6, 2026

Arms and Interventions

Arm	Intervention/Treatment
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); 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.
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); 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.

Outcome Measures

Primary Outcome Measures

1. To construct reference ranges of placental angiogenesis markers specific to women with primary APS in pregnancy [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Raffaele Hospital	Milan		Italy

Sponsors and Collaborators

• IRCCS San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• ClinicalTrials.gov Identifier: NCT05786235
• Other Study ID Numbers: APS_FLT1/PLGF
• First Posted: Mar 27, 2023
• Last Update Posted: Mar 30, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rheumatic Diseases; Pre-Eclampsia; Pregnancy Complications; Collagen Diseases; Antiphospholipid Syndrome; Immune System Diseases; Syndrome

Study Results

No Results Posted as of Mar 30, 2023