Measuring sVAP-1 as a Predictor of Pregnancy Problems

NCT ID: NCT04891315

Last Updated: 2022-08-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-25
• Study Completion Date: 2021-10-07

Brief Summary

Pre-eclampsia is a common pregnancy disorder defined as high blood pressure and protein in the urine after 20 weeks of pregnancy. It affects the function of the placenta and can cause severe complications, e.g, stroke, multiple organ damage and seizures for the mother, and fetal growth restriction or stillbirth for the baby. Pre-eclampsia can also cause long term health problems for mother and baby.

Currently, there is no test that can predict whether someone will develop pre-eclampsia, so nothing is done to intervene before the problems begin.

Results from their previous work suggest that the investigators may have found something that can be measured in a blood sample that can predict which women might develop pre-eclampsia. It is a protein known as Vascular Adhesion Protein-1 (VAP-1), and our evidence points at it being involved in the embryo attaching to the womb and also in helping the development of the placenta by helping to get the right cells to where they are needed.

The investigators will test blood samples from 451 pregnant women who come to the Leicester Royal Infirmary for routine bloods and their first pregnancy dating scan. The investigators will then follow the outcomes of the pregnancy to see if VAP-1 in the blood of women who develop pre-eclampsia (or other pregnancy complications) is different from the ones who do not develop pregnancy complications. The ability to predict women at higher risk of pregnancy complications would ensure the application of timely interventions and appropriate management of the conditions that may help to prevent complications both during pregnancy and later life.

The study is expected to last approximately 30 weeks and the participants will be asked to give one extra tube of blood whilst having their routine bloods taken and to also consent to follow up of medical records until the end of the pregnancy.

Conditions

Pregnancy Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant women

Women aged 16+ in early pregnancy (before 20 weeks of gestation).

Blood test for soluble VAP-1 (sVAP-1).

Intervention Type: DIAGNOSTIC_TEST

\~5ml blood will be taken and sVAP-1 will be measure by Enzyme linked Immunosorbent Assay

Interventions

Blood test for soluble VAP-1 (sVAP-1).

\~5ml blood will be taken and sVAP-1 will be measure by Enzyme linked Immunosorbent Assay

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Female participants who are in early pregnancy (<20 weeks gestational age).
• 16 years and above
• Patient consents to take part in the study

Exclusion Criteria

• Patient declines to be involved in the study
• Unsuccessful venepuncture

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leicester Royal Infirmary

Leicester, , United Kingdom

Countries

United Kingdom

Other Identifiers

289532

Identifier Type: OTHER

Identifier Source: secondary_id

21/EM/0090

Identifier Type: OTHER

Identifier Source: secondary_id

0820

Identifier Type: -

Identifier Source: org_study_id