Measuring sVAP-1 as a Predictor of Pregnancy Problems

Pregnancy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04891315
• Other study ID #: 0820
• Secondary ID: 28953221/EM/0090
• Status: Terminated
• Start date: July 25, 2021
• Est. completion date: October 7, 2021

Study information

• Verified date: September 2021
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 102
• Est. completion date: October 7, 2021
• Est. primary completion date: October 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Complications

Intervention

Diagnostic Test:
• Blood test for soluble VAP-1 (sVAP-1).
~5ml blood will be taken and sVAP-1 will be measure by Enzyme linked Immunosorbent Assay

Locations

Country	Name	City	State
United Kingdom	Leicester Royal Infirmary	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University of Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of sVAP-1 levels with pregnancy complications: Pre-eclampsia	Diagnosis of pre-eclampsia defined as: New-onset hypertension (>140 mm Hg systolic or >90 mm Hg diastolic) after 20 weeks of pregnancy and the coexistence of one or both of the following new-onset conditions: Proteinuria (urine protein:creatinine ratio =30 mg/mmol, or albumin:creatinine ratio =8 mg/mmol, or =1 g/L [2+] on dipstick testing) Other maternal organ dysfunction.; sVAP-1 levels will be measured by ELISA	During pregnancy up to 42 weeks
Primary	Correlation of sVAP-1 levels with pregnancy complications: hypertension in pregnancy	Diagnosis of hypertension in pregnancy defined as: Systolic BP = 140 mm Hg or diastolic BP = 90 mmHg.; sVAP-1 levels will be measured by ELISA	During pregnancy up to 42 weeks
Primary	Correlation of sVAP-1 levels with pregnancy complications: Gestational diabetes.	Diagnosis of gestational diabetes defined as: A fasting plasma glucose level of 5.6 mmol/litre or above or A 2-hour plasma glucose level of 7.8 mmol/litre or above; sVAP-1 levels will be measured by ELISA	During pregnancy up to 42 weeks
Primary	Correlation of sVAP-1 levels with Fetal outcomes: Stillbirth	Stillbirths will be defined as: The death of a baby before or during birth after 24 weeks of gestation.; sVAP-1 levels will be measured by ELISA	During pregnancy from 24 to 42 weeks
Primary	Correlation of sVAP-1 levels with Fetal outcomes: Fetal growth restriction	Fetal growth restriction will be defined as: Estimated fetal weight >10th centile for gestational age.; sVAP-1 levels will be measured by ELISA	During pregnancy up to 42 weeks
Primary	Correlation of sVAP-1 levels with Fetal outcomes: Fetal macrosomia	Fetal macrosomia,will be defined as: Estimated fetal weight >90th centile for gestational age.; sVAP-1 levels will be measured by ELISA	During pregnancy up to 42 weeks
Primary	Correlation of sVAP-1 levels with Fetal outcomes: Preterm labour	Preterm labour be defined as: Birth <37 weeks.; sVAP-1 levels will be measured by ELISA	During pregnancy up to 37 weeks
Primary	Correlation of sVAP-1 levels with Fetal outcomes: Miscarriage	Miscarriage will be defined as: Occurrence of spontaneous abortion <24 weeks' gestation.; sVAP-1 levels will be measured by ELISA	During pregnancy up to 24 weeks
Secondary	Correlation of sVAP-1 levels with patient characteristics: Age	Age will be measured in years.; sVAP-1 levels will be measured by ELISA	At time of recruitment
Secondary	Correlation of sVAP-1 levels with patient characteristics: Weight	Weight will be measured in kilograms.; sVAP-1 levels will be measured by ELISA.	During pregnancy up to 42 weeks
Secondary	Correlation of sVAP-1 levels with patient characteristics: BMI	Weight and height will be combined to report BMI in kg/m^2.; sVAP-1 levels will be measured by ELISA.	During pregnancy up to 42 weeks
Secondary	Correlation of sVAP-1 levels with patient characteristics: Ethnicity	Ethnicity will be recorded as described on the medical records of the patient.; sVAP-1 levels will be measured by ELISA.	At time of recruitment
Secondary	Correlation of sVAP-1 levels with patient characteristics: Smoking status	Smoking status will be recorded as current/ex/never.; sVAP-1 levels will be measured by ELISA.	During pregnancy up to 42 weeks
Secondary	Correlation of sVAP-1 levels with patient characteristics: Gestation at time of recruitment	Gestation at time of recruitment will be measured in weeks.; sVAP-1 levels will be measured by ELISA.	At time of recruitment
Secondary	Correlation of sVAP-1 levels with patient characteristics: Parity	Parity will be recorded as the number of births with a gestational age of 24 weeks.; sVAP-1 levels will be measured by ELISA.	At time of recruitment
Secondary	Correlation of sVAP-1 levels with patient characteristics: Gravidity	Gravidity will be recorded as the total number of pregnancies.; sVAP-1 levels will be measured by ELISA.	At time of recruitment
Secondary	Correlation of sVAP-1 levels with patient characteristics: Pre-existing medical conditions	Pre-existing medical conditions will be recorded as reported on the patient's medical records.; sVAP-1 levels will be measured by ELISA.	At time of recruitment
Secondary	Correlation of sVAP-1 levels with patient characteristics: Medications at time of booking	Medications at time of booking will be recorded as reported on the patient's medical records.; sVAP-1 levels will be measured by ELISA.	At time of recruitment