An observational study in Pre-Eclampsia, sponsored by IRCCS Burlo Garofolo. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by IRCCS Burlo Garofolo · Observational
Among 16 studies in Pre-Eclampsia with a site in Italy — 9 open to participants now, 10 under way, none of them phase 3. Pre-Eclampsia · Italy.
Among the 16 studies in Pre-Eclampsia with a site in Italy, this one is the 9th largest by planned enrollment of the 10 observational ones that give a count, is one of 4 that started in 2023, is one of 10 observational ones, and was the 10th registered.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
Browse Pre-Eclampsia studies →9 of the 16 studies in Pre-Eclampsia with a site in Italy are open now. Recruiting first, the newest first:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 18+ · Women only
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Sites in Italy
Ages 18–65 · Women only · Healthy volunteers
Istituto Clinico Humanitas · Sites in Italy
Ages 18+ · Women only · Healthy volunteers
IRCCS San Raffaele · Sites in Italy
Ages 18–45 · Women only · Healthy volunteers
Istituto Clinico Humanitas · Sites in Italy
Ages 18+ · Women only
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 4 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 54 is below the median of 165 across 397 observational studies indexed under Pre-Eclampsia.
Median enrollment 82 across the 6 interventional studies, 243 across the 10 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.
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1 of 16 have an industry lead sponsor. The 10 most frequent:
IRCCS Burlo Garofolo is the lead sponsor of 89 studies on the registry; 32 are open to participants now.
IRCCS Burlo Garofolo has 1 study filed under Pre-Eclampsia — fewer than ten, so there is no comparison to draw.
3 of the studies in Pre-Eclampsia with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07092644Fondazione Policlinico Universitario Agostino Gemelli IRCCSPreeclampsia and Fetal Heart Malformations: Looking to Maternal Heart | 2026-11 |
| NCT06317467IRCCS Burlo GarofoloRole of Anti-C1q Autoantibodies in Pregnancy | 2026-12 |
| NCT06893978Fondazione Policlinico Universitario Agostino Gemelli IRCCSPlacental Organoids Development: Application in the Study of the Human Reproduction Pathophysiology. | 2027-11 |
Add all 3 to your calendar (.ics) → With an account.
Among the 16 studies in Pre-Eclampsia with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Preeclampsia (PE) is a very frequent obstetric complication. C1q, the first recognition molecule of the classical pathway of complement system (C), represents a double-edged molecule in determining pregnancy outcomes. In animal models, C1q deficiency caused the development of a dysfunctional placenta and PE-like symptoms. Conversely, lower levels of C components were detected in the sera of patients with PE due to C consumption and increased deposition of activated C components in the placenta, as well as to the binding to placental apoptotic bodies, syncytiotrophoblast microvesicles (STBM) and debris which are increased in the circulation of patients with PE.
C1q is a hexameric glycoprotein of 460kDa composed by six copies of three polypeptide chains A, B and C, each made by a C-terminal globular head (gC1q) and a N-terminal collagen-like region (CLR). This molecule can be the target of an antibody response. Autoantibodies targeting C1q were first recognized in the serum of Systemic Lupus Erythematosus (SLE) patients. The presence of anti-C1q autoantibodies was also detected in patient affected by autoimmune disease (ie, kidney disorders, vasculitis, thyroiditis). Almost all of these autoimmune disorders are associated with an increased risk of developing PE during pregnancy.
Anti-C1q detection mainly concerns the prediction of the onset of lupus nephritis (LN) in SLE patients. Although anti-C1q autoantibodies do not deplete circulating C1q, their presence in maternal circulation and in placenta may trigger improper C activation and impair C1q activity. In pregnancies complicated by autoimmune affection such as SLE, autoimmune thyroid disorders and Antiphospholipid syndrome (APS) the prevalence of anti-C1q appeared to be higher than in control pregnancies and associated with miscarriage. High levels of anti-C1q have been found in a group of Japanese patients suffering recurrent pregnancy loss (RPL). In a group of anti-C1q positive healthy pregnancies and LN patients was assessed whether C1q autoantigenic behaviour could vary among individuals with or without correlated manifestation. Sera from healthy pregnancies and LN patients were screened for the presence of autoantibodies against the CLR fragment and/or the gC1q: antibodies against gC1q were found in both groups, whereas anti-CLR were only detected in the LN one, suggesting that only the latter may have a pathogenic role. Despite this, the biological functions of anti-C1q remain far from clear
Pregnant women, women attending the medically assisted procreation
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 thyroiditis attending the medically assisted procreation department or the Department of Rheumatology, Division of Internal Medicine, University Medical Centre Ljubljana, Ljubljana, Slovenia
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group
Other: Blood sampling
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
Other: Blood sampling
Patients attending the medically assisted procreation department or the Department of Rheumatology, Division of Internal Medicine, University Medical Centre Ljubljana, Ljubljana, Slovenia
Other: Blood sampling
Four blood samples will be collected, in conjunction with the collection of samples already programmed for assistance during pregnancy: blood sampling for the B-test (within the 13th week of gestation), at the blood test centre of the Institute for Maternal and Child Health, IRCCS Burlo Garofolo; blood sampling for toxoplasmosis or blood sugar level, upon execution of the morphological ultrasound scanning (around the 20th and 34th weeks of gestation), at the blood test centre of the Institute for Maternal and Child Health, IRCCS Burlo Garofolo, as well. Finally, 40 days after delivery, during routine gynaecological control after the puerperium.
For patient of group 2, the blood sample will be collected at the time of the diagnosis of PE and 40-50 days after delivery in Obstetrics and Gynaecology Department of the institute or in Department of Biomedical Sciences, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies
Time frame: 8-12 weeks of gestation
Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies
Time frame: 8-12 weeks of gestation
Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies
Time frame: 20-24 weeks of gestation.
Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies
Time frame: 20-24 weeks of gestation.
Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies
Time frame: 34-38 weeks of gestation.
Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies
Time frame: 34-38 weeks of gestation.
Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies
Time frame: 40-50 days after delivery.
Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies
Time frame: 40-50 days after delivery.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Dec 2026, 39 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 39 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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IRCCS Burlo Garofolo