Preterm BirthBIO-PRETERMNCT05693285
Preterm Birth and Biomarkers for Cardiovascular Disease
An observational study of Preterm Birth and Cardiovascular Diseases, run by Uppsala University at 1 site in Sweden.
Trial summary
Preterm birth is associated with maternal increased risk of cardiovascular disease later in life. In an observational case- control study, investigators want to evaluate whether women with preterm birth have increased levels of biomarkers for cardiovascular disease, to reveal potential pathophysiological mechanisms in… Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- Preterm Birth, Cardiovascular Diseases
- How many people
- 65 participants
- Where
- 1 siteSweden
- Study dates
- 14 Nov 2022to 2 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women were identified in the Uppsala Biobank of pregnant women at their first pregnancy. Investigators invited women identified as cases or controls to participate by one blood sample and a visit collecting information about cardiovascular risk factors.
Who may be able to join
- Women identified as cases or controls
Who cannot join
- System inflammatory disease
- Smoking at the time of the pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Preterm birth is associated with maternal increased risk of cardiovascular disease later in life. In an observational case- control study, investigators want to evaluate whether women with preterm birth have increased levels of biomarkers for cardiovascular disease, to reveal potential pathophysiological mechanisms in common.
Read the detailed description
Women with spontaneous preterm birth in first pregnancy and a group of matched controls with spontaneous birth in normal time where invited to participate in the study. Participants were identified from the Biobank of Pregnant Women in Uppsala. Levels of cardiovascular biomarkers will be analyzed in plasma samples from the pregnancy and at a follow-up visit where investigators also collect information about other cardiovascular risk factors and lipid status.
- Conditions
- Preterm Birth, Cardiovascular Diseases
- Being tested
- No intervention
- Medical subject headings
- Premature Birth, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Preterm birth | Women with spontaneous preterm birth in first pregnancy Receives: Other: No intervention | |
| Controls | Matched controls with spontaneous delivery in normal time in first pregnancy Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of Factor XII in plasma in women with preterm birth in compared to a control group with delivery in normal time.
Levels of Factor XII in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Measured: spring 2023
Levels of complement C5 in women with preterm birth in compared to a control group with delivery in normal time.
Levels of complement C5 in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Measured: spring 2023
Levels of apolipoprotein M in women with preterm birth in compared to a control group with delivery in normal time.
Levels of apolipoprotein M in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Measured: spring 2023
Levels of fibrinogen in women with preterm birth in compared to a control group with delivery in normal time.
Levels of fibrinogen in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Measured: spring 2023
Levels of plasma kallikrein in women with preterm birth in compared to a control group with delivery in normal time.
Levels of plasma kallikrein in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Measured: spring 2023
Levels of vitamin D binding protein in women with preterm birth in compared to a control group with delivery in normal time.
Levels of vitamin D binding protein in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Measured: spring 2023
Levels of cadherin -5 in women with preterm birth in compared to a control group with delivery in normal time.
Levels of cadherin -5 in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Measured: spring 2023
Levels of growth/differentiation Factor-15 (GDF-15) in women with preterm birth in compared to a control group with delivery in normal time. preterm birth compared to a control group with delivery in normal time.
Levels of growth/differentiation Factor-15 (GDF-15) in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Measured: spring 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start14 Nov 2022
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Christersson, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693285
- Sponsor's protocol ID
- UU
- Acronym
- BIO-PRETERM
- Status last verified
- Jan 2023
- First submitted
- 12 Dec 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cederlof ET, Lager S, Larsson A, Sundstrom Poromaa I, Lindahl B, Wikstrom AK, Christersson C. Biomarkers associated with cardiovascular disease in women with spontaneous preterm birth: A case-control study. Acta Obstet Gynecol Scand. 2024 May;103(5):970-979. doi: 10.1111/aogs.14813. Epub 2024 Feb 20.
PubMed 38379394
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Birth and Biomarkers for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05693285
- Acronym / sponsor ID
- BIO-PRETERM / UU
- Conditions
- Preterm Birth, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 20 Jan 2023 (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.
Preterm birth is associated with maternal increased risk of cardiovascular disease later in life. In an observational case- control study, investigators want to evaluate whether women with preterm birth have increased levels of biomarkers for cardiovascular disease, to reveal potential pathophysiological mechanisms in common.
Detailed description
Women with spontaneous preterm birth in first pregnancy and a group of matched controls with spontaneous birth in normal time where invited to participate in the study. Participants were identified from the Biobank of Pregnant Women in Uppsala. Levels of cardiovascular biomarkers will be analyzed in plasma samples from the pregnancy and at a follow-up visit where investigators also collect information about other cardiovascular risk factors and lipid status.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm birth | – | Other: No interventionWomen with spontaneous preterm birth in first pregnancy |
| Controls | – | Other: No interventionMatched controls with spontaneous delivery in normal time in first pregnancy |
Who may qualify
- Ages
- Up to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women were identified in the Uppsala Biobank of pregnant women at their first pregnancy. Investigators invited women identified as cases or controls to participate by one blood sample and a visit collecting information about cardiovascular risk factors.
Key inclusion criteria (1 listed)
- Women identified as cases or controls
Key exclusion criteria (2 listed)
- System inflammatory disease
- Smoking at the time of the pregnancy
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 |
|---|---|---|
| No interventionNo intervention | Other | Controls, Preterm birth |
Primary outcome
Levels of Factor XII in plasma in women with preterm birth in compared to a control group with delivery in normal time.
Time frame: spring 2023
Levels of Factor XII in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Levels of complement C5 in women with preterm birth in compared to a control group with delivery in normal time.
Time frame: spring 2023
Levels of complement C5 in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Levels of apolipoprotein M in women with preterm birth in compared to a control group with delivery in normal time.
Time frame: spring 2023
Levels of apolipoprotein M in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Levels of fibrinogen in women with preterm birth in compared to a control group with delivery in normal time.
Time frame: spring 2023
Levels of fibrinogen in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Levels of plasma kallikrein in women with preterm birth in compared to a control group with delivery in normal time.
Time frame: spring 2023
Levels of plasma kallikrein in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Levels of vitamin D binding protein in women with preterm birth in compared to a control group with delivery in normal time.
Time frame: spring 2023
Levels of vitamin D binding protein in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Levels of cadherin -5 in women with preterm birth in compared to a control group with delivery in normal time.
Time frame: spring 2023
Levels of cadherin -5 in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Levels of growth/differentiation Factor-15 (GDF-15) in women with preterm birth in compared to a control group with delivery in normal time. preterm birth compared to a control group with delivery in normal time.
Time frame: spring 2023
Levels of growth/differentiation Factor-15 (GDF-15) in plasma will be analyzed at two times, both in the actual pregnancy and at a follow-up visit where information about cardiovascular risk factors and lipid status is collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 38379394Cederlof ET, Lager S, Larsson A, Sundstrom Poromaa I, Lindahl B, Wikstrom AK, Christersson C. Biomarkers associated with cardiovascular disease in women with spontaneous preterm birth: A case-control study. Acta Obstet Gynecol Scand. 2024 May;103(5):970-979. doi: 10.1111/aogs.14813. Epub 2024 Feb 20.
- Individual participant dataSharing planned: No
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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.
Christina Christersson principal investigator
Uppsala University
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 Preterm Birth and Cardiovascular Diseases, run by Uppsala University at 1 site in Sweden.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jan 2023. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Levels of Factor XII in plasma in women with preterm birth in compared to a control group with delivery in normal time. (time frame: spring 2023). 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?
On the ClinicalTrials.gov record for NCT05693285, which also lists 1 linked publication.
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 26 Jan 2023.