Clinical trial NCT05693285: Preterm Birth and Biomarkers for Cardiovascular Disease
Official title: Preterm Birth and Biomarkers for Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Cardiovascular Diseases
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 65
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Women identified as cases or controls

Exclusion Criteria:

* System inflammatory disease
* Smoking at the time of the pregnancy

Primary outcomes:
measure: Levels of Factor XII in plasma in women with preterm birth in compared to a control group with delivery in normal time.
timeFrame: spring 2023
measure: Levels of complement C5 in women with preterm birth in compared to a control group with delivery in normal time.
timeFrame: spring 2023
measure: Levels of apolipoprotein M in women with preterm birth in compared to a control group with delivery in normal time.
timeFrame: spring 2023
measure: Levels of fibrinogen in women with preterm birth in compared to a control group with delivery in normal time.
timeFrame: spring 2023
measure: Levels of plasma kallikrein in women with preterm birth in compared to a control group with delivery in normal time.
timeFrame: spring 2023
measure: Levels of vitamin D binding protein in women with preterm birth in compared to a control group with delivery in normal time.
timeFrame: spring 2023
measure: Levels of cadherin -5 in women with preterm birth in compared to a control group with delivery in normal time.
timeFrame: spring 2023
measure: 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.
timeFrame: spring 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Department of Medical Sciences, Uppsala University
Study officials:
affiliation: Uppsala University
name: Christina Christersson
role: PRINCIPAL_INVESTIGATOR
References: