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TerminatedNCT04891315

Measuring sVAP-1 as a Predictor of Pregnancy Problems

Measuring Soluble Vascular Adhesion Protein-1 as a Potential Biomarker for Predicting Pregnancy Problems

Status
Terminated
Phase
Study type
Observational
Enrollment
102 (actual)
Sponsor
University of Leicester · Academic / Other
Sex
Female
Age
16 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBlood test for soluble VAP-1 (sVAP-1).\~5ml blood will be taken and sVAP-1 will be measure by Enzyme linked Immunosorbent Assay

Timeline

Start date
2021-07-25
Primary completion
2021-10-07
Completion
2021-10-07
First posted
2021-05-18
Last updated
2022-08-11

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT04891315. Inclusion in this directory is not an endorsement.

Measuring sVAP-1 as a Predictor of Pregnancy Problems (NCT04891315) · Clinical Trials Directory