Measuring sVAP-1 as a Predictor of Pregnancy Problems

University of Leicester

Status: Terminated

Conditions: Pregnancy Complications

Treatments: Diagnostic Test: Blood test for soluble VAP-1 (sVAP-1).

Study type: Observational

Funder types: Other

Identifiers

NCT04891315

0820

21/EM/0090 (Other Identifier)

289532 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

102 participants in 1 patient group

Pregnant women

Description:

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

Treatment:

Diagnostic Test: Blood test for soluble VAP-1 (sVAP-1).