Pre-EclampsiaNCT06317467
Role of Anti-C1q Autoantibodies in Pregnancy
An observational study of Pre-Eclampsia, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Eclampsia
- What is being tested?
- Blood sampling
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 13 Sep 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women, women attending the medically assisted procreation
Who may be able to join
None listed.
Who cannot join
- Women aged under 18 years
- Viral or bacterial blood transmitted infections.
- Patients whose informed consent cannot be obtained.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
Chiara Agostinis, BSc, 040/5588652, chiara.agostinis@burlo.trieste.it
About this study
Official title: 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?
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
- Conditions
- Pre-Eclampsia
- Being tested
- Blood sampling
- Keywords
- Anti-C1q autoantibodies, Intra Uterine Growth Restriction (IUGR), Pre-eclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
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.
Blood samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Women with physiological pregnancies | Control group Receives: Other: Blood sampling | |
| 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 Receives: Other: Blood sampling | |
| Women affected by SLE, APS, or autoimmune thyroiditis | Patients attending the medically assisted procreation department or the Department of Rheumatology, Division of Internal Medicine, University Medical Centre Ljubljana, Ljubljana, Slovenia Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies
Measured: 8-12 weeks of gestation
Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies
Measured: 8-12 weeks of gestation
Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies
Measured: 20-24 weeks of gestation.
Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies
Measured: 20-24 weeks of gestation.
Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies
Measured: 34-38 weeks of gestation.
Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies
Measured: 34-38 weeks of gestation.
Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies
Measured: 40-50 days after delivery.
Between groups difference in percentage of anti-cC1q compared to the total anti-C1q autoantibodies
Measured: 40-50 days after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start13 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317467
- Sponsor's protocol ID
- RC 01/2023
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT06317467
- Acronym / sponsor ID
- RC 01/2023
- Conditions
- Pre-Eclampsia
- Keywords
- Anti-C1q autoantibodies, Intra Uterine Growth Restriction (IUGR), Pre-eclampsia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women with physiological pregnancies | – | Other: Blood samplingControl group |
| Patients diagnosed for PE | – | Other: Blood samplinghypertension 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 |
| Women affected by SLE, APS, or autoimmune thyroiditis | – | Other: Blood samplingPatients attending the medically assisted procreation department or the Department of Rheumatology, Division of Internal Medicine, University Medical Centre Ljubljana, Ljubljana, Slovenia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women, women attending the medically assisted procreation
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Women aged under 18 years
- Viral or bacterial blood transmitted infections.
- Patients whose informed consent cannot be obtained.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingFour 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. | Other | Patients diagnosed for PE, Women affected by SLE, APS, or autoimmune thyroiditis, Women with physiological pregnancies |
| Blood samplingFor 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. | Other | Patients diagnosed for PE, Women affected by SLE, APS, or autoimmune thyroiditis, Women with physiological pregnancies |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-Eclampsia, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Agostinis, BSc (+39.040.5588652, chiara.agostinis@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between groups difference in percentage of anti-gC1q compared to the total anti-C1q autoantibodies (time frame: 8-12 weeks of gestation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.