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Clinical Trials/NCT05693285
NCT05693285
Completed
Not Applicable

Preterm Birth and Biomarkers for Cardiovascular Disease

Uppsala University1 site in 1 country65 target enrollmentNovember 14, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Uppsala University
Enrollment
65
Locations
1
Primary Endpoint
Levels of Factor XII in plasma in women with preterm birth in compared to a control group with delivery in normal time.
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 14, 2022
End Date
December 2, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women identified as cases or controls

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 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 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 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 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.

Study Sites (1)

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