Investigating the role of anti-C1q autoantibodies in pregnancy complications
Characterization of the Physiological and the Pathological Role of Anti-C1q Autoantibodies in Pregnancy: a Potential Treatment for Pre-eclampsia to Prevent Fetal Intrauterine Growth Restriction?
This study is trying to see if certain antibodies in the blood are linked to pregnancy complications like pre-eclampsia in women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | IRCCS Burlo Garofolo Academic / other |
| Locations | 1 site (Trieste) |
| Trial ID | NCT06317467 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between anti-C1q autoantibodies and pre-eclampsia, a common complication during pregnancy. It involves blood sampling from women with physiological pregnancies, those diagnosed with pre-eclampsia, and women with autoimmune conditions. The study seeks to understand how C1q, a key molecule in the complement system, may influence pregnancy outcomes and the development of pre-eclampsia. By analyzing the presence of these autoantibodies, researchers hope to gain insights into their potential role in placental dysfunction and related complications.
Who should consider this trial
Good fit: Ideal candidates include women with normal pregnancies, those diagnosed with pre-eclampsia, and women with autoimmune disorders such as systemic lupus erythematosus.
Not a fit: Patients under 18 years old or those with viral or bacterial blood-transmitted infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of pre-eclampsia, potentially enhancing maternal and fetal health outcomes.
How similar studies have performed: While the role of C1q in pregnancy is being explored, this specific investigation into anti-C1q autoantibodies in relation to pre-eclampsia is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Group 1. Women occurring physiological pregnancies that sign the consent to participate in the study and agree to spontaneously return to the maternal hospital 40 days after delivery. Group 2. Patients diagnosed for PE (hypertension arisen suddenly after the 20th week of pregnancy with associated proteinuria, greater than or equal to 300 mg/24 hours often corresponding to 30 mg/dL (1+) on a single sample). Group 3. Women affected by SLE, APS, or autoimmune thyroiditis attending the medically assisted procreation department or the Department of Rheumatology, Division of Internal Medicine, University Medical Centre Ljubljana, Ljubljana, Slovenia Exclusion criteria 1. Women aged under 18 years 2. Viral or bacterial blood transmitted infections. 3. Patients whose informed consent cannot be obtained.
Where this trial is running
Trieste
- Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" — Trieste, Italy (Recruiting)
Study contacts
- Study coordinator: Chiara Agostinis, BSc
- Email: chiara.agostinis@burlo.trieste.it
- Phone: +39.040.5588652
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.