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| ID | Type | Description | Link |
|---|---|---|---|
| 289532 | Other Identifier | IRAS | |
| 21/EM/0090 | Other Identifier | Leicester Central Research Ethics Committee |
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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant women | Women aged 16+ in early pregnancy (before 20 weeks of gestation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Correlation of sVAP-1 levels with patient characteristics: Weight |
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Inclusion Criteria:
Exclusion Criteria:
No: Eligibility is not based on gender
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leicester Royal Infirmary | Leicester | United Kingdom |
We have no plans to share individual participant data.
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| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| D016640 | Diabetes, Gestational |
| D005317 | Fetal Growth Retardation |
| D050497 | Stillbirth |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Serum
| 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 |
Weight will be measured in kilograms.
sVAP-1 levels will be measured by ELISA.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At time of recruitment |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005315 | Fetal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005313 | Fetal Death |
| D003643 | Death |