Clinical trial NCT04891315: Measuring sVAP-1 as a Predictor of Pregnancy Problems
Official title: Measuring Soluble Vascular Adhesion Protein-1 as a Potential Biomarker for Predicting Pregnancy Problems
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy Complications
Keywords: Hypertension in pregnancy
Pre-eclampsia
Gestational diabetes
Fetal growth restriction
Large for gestational age
Stillbirth
Miscarriage
Lead sponsor: University of Leicester
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 102
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Correlation of sVAP-1 levels with pregnancy complications: Pre-eclampsia
timeFrame: During pregnancy up to 42 weeks
measure: Correlation of sVAP-1 levels with pregnancy complications: hypertension in pregnancy
timeFrame: During pregnancy up to 42 weeks
measure: Correlation of sVAP-1 levels with pregnancy complications: Gestational diabetes.
timeFrame: During pregnancy up to 42 weeks
measure: Correlation of sVAP-1 levels with Fetal outcomes: Stillbirth
timeFrame: During pregnancy from 24 to 42 weeks
measure: Correlation of sVAP-1 levels with Fetal outcomes: Fetal growth restriction
timeFrame: During pregnancy up to 42 weeks
measure: Correlation of sVAP-1 levels with Fetal outcomes: Fetal macrosomia
timeFrame: During pregnancy up to 42 weeks
measure: Correlation of sVAP-1 levels with Fetal outcomes: Preterm labour
timeFrame: During pregnancy up to 37 weeks
measure: Correlation of sVAP-1 levels with Fetal outcomes: Miscarriage
timeFrame: During pregnancy up to 24 weeks
Secondary outcomes:
measure: Correlation of sVAP-1 levels with patient characteristics: Age
timeFrame: At time of recruitment
measure: Correlation of sVAP-1 levels with patient characteristics: Weight
timeFrame: During pregnancy up to 42 weeks
measure: Correlation of sVAP-1 levels with patient characteristics: BMI
timeFrame: During pregnancy up to 42 weeks
measure: Correlation of sVAP-1 levels with patient characteristics: Ethnicity
timeFrame: At time of recruitment
measure: Correlation of sVAP-1 levels with patient characteristics: Smoking status
timeFrame: During pregnancy up to 42 weeks
measure: Correlation of sVAP-1 levels with patient characteristics: Gestation at time of recruitment
timeFrame: At time of recruitment
measure: Correlation of sVAP-1 levels with patient characteristics: Parity
timeFrame: At time of recruitment
measure: Correlation of sVAP-1 levels with patient characteristics: Gravidity
timeFrame: At time of recruitment
measure: Correlation of sVAP-1 levels with patient characteristics: Pre-existing medical conditions
timeFrame: At time of recruitment
measure: Correlation of sVAP-1 levels with patient characteristics: Medications at time of booking
timeFrame: At time of recruitment
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
Study officials:
References: