Cardiovascular DisorderSOMPNCT06720857
Predictive Value of SFlt-1/PlGF Ratio for the Diagnosis of Cardiovascular Disorders in the Puerperium: Pilot Study
A study testing Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium in people with Cardiovascular Disorder and Puerperium; Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this clinical trial is to identify a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks postpartum) by making use of a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy for prediction of preeclampsia)… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disorder, Puerperium; Disease
- What is being tested?
- Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteItaly
- Study dates
- 6 Apr 2022to 31 Dec 2026
- Phase
- Interventional
- 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 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age > 18 years and < 44 years
- Single pregnancy
- Understanding and obtaining informed consent
Who cannot join
- Language misunderstanding
- Twin pregnancies
- Inability to comply with study arrangements (e.g., inability to home recording of blood pressure values)
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
About this study
The goal of this clinical trial is to identify a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks postpartum) by making use of a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy for prediction of preeclampsia), demographic, clinical and laboratory data. The goal is to create a score that allows the clinician to identify those expectant mothers who at discharge are at increased risk of developing cardiovascular/hypertensive disorders.
Read the detailed description
At the time of recruitment, patients will be adequately informed about the purpose and modality of the study and will sign an informed consent form for participation in the study. On the first postpartum day, on the occasion of the blood tests included in the normal care routine, the patients will undergo measurement of circulating levels of angiogenic factors (soluble fms-like tyrosine kinase, sFlt-1; placental growth factor, PlGF), already used in pregnancy for predicting the risk of early and late preeclampsia. Marker assay kits will be provided free of charge by the company DASIT. Prior to collection, systolic and diastolic blood pressure will be measured by manual sphygmomanometer in supine position after at least 15 minutes of rest.
Anamnestic, clinical and laboratory data regarding pregnancy, childbirth and puerperium will be collected.
A diary for recording blood pressure values in the puerperium will be provided on the same occasion. The patient will be instructed in home blood pressure monitoring which should take place twice a week for the next 6 weeks after delivery. Return of the diary containing the pressure data will be done by e-mail. Postpartum hypertension is defined according to ACOG criteria as a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. If altered blood pressure values are found, the patient will be invited to go to the emergency department or to her primary care physician and treated according the usual clinical practice.
- Conditions
- Cardiovascular Disorder, Puerperium; Disease
- Being tested
- Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium
- Keywords
- SFlt-1/PlGF ratio
- Medical subject headings
- Cardiovascular Diseases, Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperiumDiagnostic test
Identification of a risk stratification model for cardiovascular/hypertensive disorders in the puerperium using a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy for prediction of preeclampsia), demographic, clinical and laboratory data.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive disorders in the puerperium | Experimental | Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium Receives: Diagnostic Test: Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks after delivery)
Through a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy to predict preeclampsia), demographic, clinical and laboratory data.
Measured: "From enrollment to the end of treatment (6 weeks after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start6 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DisorderStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Farina, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720857
- Sponsor's protocol ID
- SOMP
- Acronym
- SOMP
- Status last verified
- Oct 2024
- First submitted
- 3 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of SFlt-1/PlGF Ratio for the Diagnosis of Cardiovascular Disorders in the Puerperium: Pilot Study
- ClinicalTrials.gov ID
- NCT06720857
- Acronym / sponsor ID
- SOMP / SOMP
- Conditions
- Cardiovascular Disorder, Puerperium; Disease
- Keywords
- SFlt-1/PlGF ratio
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 181 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Dec 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.
The goal of this clinical trial is to identify a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks postpartum) by making use of a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy for prediction of preeclampsia), demographic, clinical and laboratory data. The goal is to create a score that allows the clinician to identify those expectant mothers who at discharge are at increased risk of developing cardiovascular/hypertensive disorders.
Detailed description
At the time of recruitment, patients will be adequately informed about the purpose and modality of the study and will sign an informed consent form for participation in the study. On the first postpartum day, on the occasion of the blood tests included in the normal care routine, the patients will undergo measurement of circulating levels of angiogenic factors (soluble fms-like tyrosine kinase, sFlt-1; placental growth factor, PlGF), already used in pregnancy for predicting the risk of early and late preeclampsia. Marker assay kits will be provided free of charge by the company DASIT. Prior to collection, systolic and diastolic blood pressure will be measured by manual sphygmomanometer in supine position after at least 15 minutes of rest.
Anamnestic, clinical and laboratory data regarding pregnancy, childbirth and puerperium will be collected.
A diary for recording blood pressure values in the puerperium will be provided on the same occasion. The patient will be instructed in home blood pressure monitoring which should take place twice a week for the next 6 weeks after delivery. Return of the diary containing the pressure data will be done by e-mail. Postpartum hypertension is defined according to ACOG criteria as a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg. If altered blood pressure values are found, the patient will be invited to go to the emergency department or to her primary care physician and treated according the usual clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertensive disorders in the puerperium | Experimental | Diagnostic Test: Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperiumIdentification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age > 18 years and < 44 years
- Single pregnancy
- Understanding and obtaining informed consent
Key exclusion criteria (3 listed)
- Language misunderstanding
- Twin pregnancies
- Inability to comply with study arrangements (e.g., inability to home recording of blood pressure values)
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 |
|---|---|---|
| Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperiumIdentification of a risk stratification model for cardiovascular/hypertensive disorders in the puerperium using a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy for prediction of preeclampsia), demographic, clinical and laboratory data. | Diagnostic test | Hypertensive disorders in the puerperium |
Primary outcome
Identification of a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks after delivery)
Time frame: "From enrollment to the end of treatment (6 weeks after delivery)
Through a panel of placental biochemical markers (sFlt-1 and PlGF: already used in pregnancy to predict preeclampsia), demographic, clinical and laboratory data.
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 9 Dec 2024.
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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. This study is not recruiting at the moment.
Antonio Farina, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identification of a risk stratification model and its predictive value for cardiovascular disorders in the puerperium in people with Cardiovascular Disorder and Puerperium; Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Dec 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a risk stratification model and its predictive value for cardiovascular/hypertensive disorders in the puerperium (6 weeks after delivery) (time frame: "From enrollment to the end of treatment (6 weeks after delivery)). 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 9 Dec 2024.