Measuring sVAP-1 as a Predictor of Pregnancy Problems

NCT04891315 | Terminated

• 3 other identifiers: 082028953221/EM/0090
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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

Keywords

Hypertension in pregnancy; Pre-eclampsia; Gestational diabetes; Fetal growth restriction; Large for gestational age; Stillbirth; Miscarriage

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• Correlation of sVAP-1 levels with patient characteristics: Age

  At time of recruitment

• Correlation of sVAP-1 levels with patient characteristics: Weight

  During pregnancy up to 42 weeks

• Correlation of sVAP-1 levels with patient characteristics: BMI

  During pregnancy up to 42 weeks

• Correlation of sVAP-1 levels with patient characteristics: Ethnicity

  At time of recruitment

• Correlation of sVAP-1 levels with patient characteristics: Smoking status

  During pregnancy up to 42 weeks

Study Arms (1)

Pregnant women

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

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

Interventions

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

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

Pregnant women

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: No: Eligibility is not based on gender
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients being given an appointment for a routine dating scan and blood test at the Leicester Royal Infirmary will have a copy of the patient information sheet included within their appointment letter and will be invited to participate in the study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Leicester Royal Infirmary

Leicester, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Diabetes, Gestational; Fetal Growth Retardation; Stillbirth; Abortion, Spontaneous

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Death; Death

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 18, 2021
• Study Start: July 25, 2021
• Primary Completion: October 7, 2021
• Study Completion: October 7, 2021
• Last Updated: August 11, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)