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Measuring sVAP-1 as a Predictor of Pregnancy Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04891315
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
University of Leicester

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.


Condition or disease Intervention/treatment
Pregnancy Complications Diagnostic Test: Blood test for soluble VAP-1 (sVAP-1).

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Study Type : Observational
Estimated Enrollment : 451 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Soluble Vascular Adhesion Protein-1 as a Potential Biomarker for Predicting Pregnancy Problems
Actual Study Start Date : July 25, 2021
Estimated Primary Completion Date : February 23, 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pregnant women
Women aged 16+ in early pregnancy (before 20 weeks of gestation).
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




Primary Outcome Measures :
  1. Correlation of sVAP-1 levels with pregnancy complications: Pre-eclampsia [ Time Frame: During pregnancy up to 42 weeks ]

    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


  2. Correlation of sVAP-1 levels with pregnancy complications: hypertension in pregnancy [ Time Frame: During pregnancy up to 42 weeks ]

    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


  3. Correlation of sVAP-1 levels with pregnancy complications: Gestational diabetes. [ Time Frame: During pregnancy up to 42 weeks ]

    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


  4. Correlation of sVAP-1 levels with Fetal outcomes: Stillbirth [ Time Frame: During pregnancy from 24 to 42 weeks ]

    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


  5. Correlation of sVAP-1 levels with Fetal outcomes: Fetal growth restriction [ Time Frame: During pregnancy up to 42 weeks ]

    Fetal growth restriction will be defined as:

    Estimated fetal weight >10th centile for gestational age.

    sVAP-1 levels will be measured by ELISA


  6. Correlation of sVAP-1 levels with Fetal outcomes: Fetal macrosomia [ Time Frame: During pregnancy up to 42 weeks ]

    Fetal macrosomia,will be defined as:

    Estimated fetal weight >90th centile for gestational age.

    sVAP-1 levels will be measured by ELISA


  7. Correlation of sVAP-1 levels with Fetal outcomes: Preterm labour [ Time Frame: During pregnancy up to 37 weeks ]

    Preterm labour be defined as:

    Birth <37 weeks.

    sVAP-1 levels will be measured by ELISA


  8. Correlation of sVAP-1 levels with Fetal outcomes: Miscarriage [ Time Frame: During pregnancy up to 24 weeks ]

    Miscarriage will be defined as:

    Occurrence of spontaneous abortion <24 weeks' gestation.

    sVAP-1 levels will be measured by ELISA



Secondary Outcome Measures :
  1. Correlation of sVAP-1 levels with patient characteristics: Age [ Time Frame: At time of recruitment ]

    Age will be measured in years.

    sVAP-1 levels will be measured by ELISA


  2. Correlation of sVAP-1 levels with patient characteristics: Weight [ Time Frame: During pregnancy up to 42 weeks ]

    Weight will be measured in kilograms.

    sVAP-1 levels will be measured by ELISA.


  3. Correlation of sVAP-1 levels with patient characteristics: BMI [ Time Frame: During pregnancy up to 42 weeks ]

    Weight and height will be combined to report BMI in kg/m^2.

    sVAP-1 levels will be measured by ELISA.


  4. Correlation of sVAP-1 levels with patient characteristics: Ethnicity [ Time Frame: At time of recruitment ]

    Ethnicity will be recorded as described on the medical records of the patient.

    sVAP-1 levels will be measured by ELISA.


  5. Correlation of sVAP-1 levels with patient characteristics: Smoking status [ Time Frame: During pregnancy up to 42 weeks ]

    Smoking status will be recorded as current/ex/never.

    sVAP-1 levels will be measured by ELISA.


  6. Correlation of sVAP-1 levels with patient characteristics: Gestation at time of recruitment [ Time Frame: At time of recruitment ]

    Gestation at time of recruitment will be measured in weeks.

    sVAP-1 levels will be measured by ELISA.


  7. Correlation of sVAP-1 levels with patient characteristics: Parity [ Time Frame: At time of recruitment ]

    Parity will be recorded as the number of births with a gestational age of 24 weeks.

    sVAP-1 levels will be measured by ELISA.


  8. Correlation of sVAP-1 levels with patient characteristics: Gravidity [ Time Frame: At time of recruitment ]

    Gravidity will be recorded as the total number of pregnancies.

    sVAP-1 levels will be measured by ELISA.


  9. Correlation of sVAP-1 levels with patient characteristics: Pre-existing medical conditions [ Time Frame: At time of recruitment ]

    Pre-existing medical conditions will be recorded as reported on the patient's medical records.

    sVAP-1 levels will be measured by ELISA.


  10. Correlation of sVAP-1 levels with patient characteristics: Medications at time of booking [ Time Frame: At time of recruitment ]

    Medications at time of booking will be recorded as reported on the patient's medical records.

    sVAP-1 levels will be measured by ELISA.



Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   No: Eligibility is not based on gender
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04891315


Contacts
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Contact: Roisin C Thomas, PhD 07951488423 rct21@le.ac.uk

Locations
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United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom
Contact: Bee K Tan       bee.k.tan@leicester.ac.uk   
Sponsors and Collaborators
University of Leicester
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT04891315    
Other Study ID Numbers: 0820
289532 ( Other Identifier: IRAS )
21/EM/0090 ( Other Identifier: Leicester Central Research Ethics Committee )
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We have no plans to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Leicester:
Hypertension in pregnancy
Pre-eclampsia
Gestational diabetes
Fetal growth restriction
Large for gestational age
Stillbirth
Miscarriage
Additional relevant MeSH terms:
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Pregnancy Complications