Pregnancy ComplicationsNCT04891315
Measuring sVAP-1 as a Predictor of Pregnancy Problems
An observational study of Pregnancy Complications, run by University of Leicester at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications
- What is being tested?
- Blood test for soluble VAP-1 (sVAP-1).
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jul 2021to 7 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Female participants who are in early pregnancy (<20 weeks gestational age).
- 16 years and above
- Patient consents to take part in the study
Who cannot join
- Patient declines to be involved in the study
- Unsuccessful venepuncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Soluble Vascular Adhesion Protein-1 as a Potential Biomarker for Predicting Pregnancy Problems
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.
Read more
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
- Being tested
- Blood test for soluble VAP-1 (sVAP-1).
- Keywords
- Hypertension in pregnancy, Pre-eclampsia, Gestational diabetes, Fetal growth restriction, Large for gestational age, Stillbirth, Miscarriage
- Medical subject headings
- Pregnancy Complications, Hypertension, Pregnancy-Induced, Pre-Eclampsia, Diabetes, Gestational, Fetal Growth Retardation, Stillbirth, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Women aged 16+ in early pregnancy (before 20 weeks of gestation). Receives: Diagnostic Test: Blood test for soluble VAP-1 (sVAP-1). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During pregnancy up to 24 weeks
Secondary outcomes (10)
Correlation of sVAP-1 levels with patient characteristics: Age
Age will be measured in years.
sVAP-1 levels will be measured by ELISA
Measured: At time of recruitment
Correlation of sVAP-1 levels with patient characteristics: Weight
Weight will be measured in kilograms.
sVAP-1 levels will be measured by ELISA.
Measured: During pregnancy up to 42 weeks
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.
Measured: During pregnancy up to 42 weeks
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.
Measured: At time of recruitment
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.
Measured: During pregnancy up to 42 weeks
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.
Measured: At time of recruitment
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.
Measured: At time of recruitment
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.
Measured: At time of recruitment
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.
Measured: At time of recruitment
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.
Measured: At time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start25 Jul 2021
- Primary completion7 Oct 2021
- Study completion7 Oct 2021
Why it stopped: A recalculation of sample size following preliminary results showed that the study was not feasible due to the requirement of a much larger sample size to reach significance. This would not be possible without significant additional funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891315
- Sponsor's protocol ID
- 0820
- Other IDs
- 289532, 21/EM/0090
- Status last verified
- Sep 2021
- First submitted
- 26 Apr 2021
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Soluble Vascular Adhesion Protein-1 as a Potential Biomarker for Predicting Pregnancy Problems
- ClinicalTrials.gov ID
- NCT04891315
- Acronym / sponsor ID
- 0820
- Conditions
- Pregnancy Complications
- Keywords
- Hypertension in pregnancy, Pre-eclampsia, Gestational diabetes, Fetal growth restriction, Large for gestational age, Stillbirth, Miscarriage
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: A recalculation of sample size following preliminary results showed that the study was not feasible due to the requirement of a much larger sample size to reach significance. This would not be possible without significant additional funding.
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 7 Oct 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Diagnostic Test: Blood test for soluble VAP-1 (sVAP-1).Women aged 16+ in early pregnancy (before 20 weeks of gestation). |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Female participants who are in early pregnancy (<20 weeks gestational age).
- 16 years and above
- Patient consents to take part in the study
Key exclusion criteria (2 listed)
- Patient declines to be involved in the study
- Unsuccessful venepuncture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test for soluble VAP-1 (sVAP-1).~5ml blood will be taken and sVAP-1 will be measure by Enzyme linked Immunosorbent Assay | Diagnostic test | Pregnant women |
Primary outcome
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
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
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
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
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
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
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
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
10 secondary outcomes
Correlation of sVAP-1 levels with patient characteristics: Age
Time frame: At time of recruitment
Correlation of sVAP-1 levels with patient characteristics: Weight
Time frame: During pregnancy up to 42 weeks
Correlation of sVAP-1 levels with patient characteristics: BMI
Time frame: During pregnancy up to 42 weeks
Correlation of sVAP-1 levels with patient characteristics: Ethnicity
Time frame: At time of recruitment
Correlation of sVAP-1 levels with patient characteristics: Smoking status
Time frame: During pregnancy up to 42 weeks
Correlation of sVAP-1 levels with patient characteristics: Gestation at time of recruitment
Time frame: At time of recruitment
Correlation of sVAP-1 levels with patient characteristics: Parity
Time frame: At time of recruitment
Correlation of sVAP-1 levels with patient characteristics: Gravidity
Time frame: At time of recruitment
Correlation of sVAP-1 levels with patient characteristics: Pre-existing medical conditions
Time frame: At time of recruitment
Correlation of sVAP-1 levels with patient characteristics: Medications at time of booking
Time frame: At time of recruitment
Results and safety
The study was stopped early (reason given: A recalculation of sample size following preliminary results showed that the study was not feasible due to the requirement of a much larger sample size to reach significance. This would not be possible without significant additional funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No. We have no plans to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: A recalculation of sample size following preliminary results showed that the study was not feasible due to the requirement of a much larger sample size to reach significance. This would not be possible without significant additional funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of sVAP-1 levels with pregnancy complications: Pre-eclampsia (time frame: During pregnancy up to 42 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.