Measuring Soluble Vascular Adhesion Protein-1 as a Potential Biomarker for Predicting Pregnancy Problems
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Correlation of sVAP-1 levels with pregnancy complications: Gestational diabetes.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants who are in early pregnancy (<20 weeks gestational age).
- •16 years and above
- •Patient consents to take part in the study
排除标准
- •Patient declines to be involved in the study
- •Unsuccessful venepuncture
结局指标
主要结局
Correlation of sVAP-1 levels with pregnancy complications: Gestational diabetes.
时间窗: 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: Fetal growth restriction
时间窗: 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 pregnancy complications: hypertension in pregnancy
时间窗: 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 Fetal outcomes: Stillbirth
时间窗: 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 macrosomia
时间窗: 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: Miscarriage
时间窗: 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
Correlation of sVAP-1 levels with pregnancy complications: Pre-eclampsia
时间窗: 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 Fetal outcomes: Preterm labour
时间窗: During pregnancy up to 37 weeks
Preterm labour be defined as: Birth \<37 weeks. sVAP-1 levels will be measured by ELISA
次要结局
- Correlation of sVAP-1 levels with patient characteristics: Gestation at time of recruitment(At time of recruitment)
- Correlation of sVAP-1 levels with patient characteristics: Gravidity(At time of recruitment)
- Correlation of sVAP-1 levels with patient characteristics: Parity(At time of recruitment)
- Correlation of sVAP-1 levels with patient characteristics: Age(At time of recruitment)
- 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)
- 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: Pre-existing medical conditions(At time of recruitment)
- Correlation of sVAP-1 levels with patient characteristics: Medications at time of booking(At time of recruitment)