BIO-PRETERM: Preterm Birth and Biomarkers for Cardiovascular Disease

• Sponsor: Uppsala University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05693285
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Actual Duration (Days): 18
• Patients Per Site Per Month: 109.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth; Cardiovascular Diseases	Other: No intervention

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 Design

• Study Type: Observational
• Actual Enrollment: 65 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Preterm Birth and Biomarkers for Cardiovascular Disease
• Actual Study Start Date: Nov 14, 2022
• Actual Primary Completion Date: Dec 2, 2022
• Actual Study Completion Date: Dec 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Preterm birth Women with spontaneous preterm birth in first pregnancy	Other: No intervention; No intervention
Controls Matched controls with spontaneous delivery in normal time in first pregnancy	Other: No intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women identified as cases or controls

Exclusion Criteria:

• System inflammatory disease

• Smoking at the time of the pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medical Sciences, Uppsala University	Uppsala		Sweden

Sponsors and Collaborators

• Uppsala University

Investigators

• Principal Investigator: Christina Christersson, Uppsala University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Uppsala University
• ClinicalTrials.gov Identifier: NCT05693285
• Other Study ID Numbers: UU
• First Posted: Jan 20, 2023
• Last Update Posted: Jan 26, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Premature Birth; Cardiovascular Diseases

Study Results

No Results Posted as of Jan 26, 2023