Preterm Birth and Biomarkers for Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

— BIO-PRETERM  

Official title:

Preterm Birth and Biomarkers for Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05693285
• Other study ID #: UU
• Status: Completed
• Start date: November 14, 2022
• Est. completion date: December 2, 2022

Study information

• Verified date: January 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 common.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 60 Years

Eligibility

Inclusion Criteria:

• Women identified as cases or controls

Exclusion Criteria:

• System inflammatory disease

• Smoking at the time of the pregnancy

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Premature Birth
• Preterm Birth

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Sweden	Department of Medical Sciences, Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	spring 2023
Primary	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.	spring 2023
Primary	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.	spring 2023
Primary	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.	spring 2023
Primary	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.	spring 2023
Primary	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.	spring 2023
Primary	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.	spring 2023
Primary	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.	spring 2023