Preterm Birth and Biomarkers for Cardiovascular Disease

Completed

• Conditions: Cardiovascular Diseases; Preterm Birth
• Interventions: Other: No intervention

• Registration Number: NCT05693285
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study Start: 2022-11-14
• Primary Completion: 2022-12-02
• Study Completion: 2022-12-02
• Study First Submitted: 2022-12-12
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-20
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

• Women identified as cases or controls

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	No intervention	Matched controls with spontaneous delivery in normal time in first pregnancy
Preterm birth	No intervention	Women with spontaneous preterm birth in first pregnancy

Primary Outcome Measures

Name	Time	Method
Levels of Factor XII in plasma in women with preterm birth in compared to a control group with delivery in normal time.	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.	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.	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.	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.	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.	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.	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.	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.

Trial Locations

Locations (1)

Department of Medical Sciences, Uppsala University; 🇸🇪 Uppsala, Sweden