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Completed

NCT Number: NCT05693285

Preterm Birth and Biomarkers for Cardiovascular Disease

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.

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Key information

Conditions

Preterm Birth Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 60 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Medical Sciences, Uppsala University

Uppsala, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women identified as cases or controls

Exclusion criteria

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Acronym: BIO-PRETERM

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 20, 2023
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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