Preterm Birth and Biomarkers for Cardiovascular Disease

NCT05693285 | Completed

• 1 other identifier: UU
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Preterm birth

Women with spontaneous preterm birth in first pregnancy

Other: No intervention

Controls

Matched controls with spontaneous delivery in normal time in first pregnancy

Other: No intervention

Interventions

No intervention OTHER

No intervention

Controls; Preterm birth

Eligibility Criteria

• Age: Up to 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Women identified as cases or controls

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Department of Medical Sciences, Uppsala University

Uppsala, Sweden

Location

Related Publications (1)

• 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.

  PMID: 38379394 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma collected at two time points, in pregnancy and at follow-up.

MeSH Terms

Conditions

Premature Birth; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Christina Christersson

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 20, 2023
• Study Start: November 14, 2022
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)