Serial Maternal Haemodynamic Monitoring in Pregnancy for the Prediction of Pre-eclampsia and Fetal Growth Restriction in a High-risk Population
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Diagnosis of pre-eclampsia
研究概览
简要总结
Pre-eclampsia (PET) and fetal growth restriction (FGR) are common complications of pregnancy that affect up to 15% of pregnancies in the UK. These conditions can have potentially devastating consequences to mothers and babies in pregnancy. Pre-term birth, that is often medically indicated to treat severe PET and FGR can cause cerebral palsy, breathing difficulty, developmental delay and even death in affected babies. Mothers who suffer from PET are at risk of seizures, strokes, multi-organ failure and future chronic hypertension. It is now thought that PET and FGR may result from poor adaptation of the maternal cardiovascular system to normal pregnancy. This project aims to study the patterns within the maternal cardiovascular system and haemodynamic profile in women who are at high risk of PET and FGR by using non-invasive methods to gather information about the functions of their hearts and major blood vessels. The investigators hope to elucidate the patterns that may offer an early warning to mothers who may develop PET and whose fetuses may be growth restricted. This would be an opportunity to more closely monitor, modify risk factors and treat earlier women who develop these conditions. Women who are at a high risk of PET and FGR as stipulated in the relevant Royal College of Obstetrics & Gynaecology and National Institute of Clinical Excellence guidelines and who give their consent will be eligible for the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged ≥18 at time of conception
- •Case subjects are at high risk of PET by NICE guidelines ( ≥1 high risk factor or >1 moderate risk factor) or high risk of SGA by RCOG Guidelines (≥1 major risk factor or ≥3 minor risk factors). Control subjects do not meet this criteria
排除标准
- •Maternal age <18 years of age at time of booking
- •Fetal structural or genetic abnormality
- •Multiple pregnancy
- •Known underlying maternal cardiac condition
结局指标
主要结局
Diagnosis of pre-eclampsia
时间窗: From 20 weeks gestation to 12 weeks post-partum.
This is defined as hypertension of \>140/90 mmHg and significant proteinuria. This is defined as urinalysis showing proteinuria of \>1+ or laboratory-quantified urine protein:creatinine ratio of \>30mg/mmol. These are assessed at every study visit.
Diagnosis of fetal growth restriction
时间窗: From 20 weeks gestation to birth.
This is diagnosed on ultrasound or at birth. During ultrasound scans at visits 2 and 3, fetal weight is estimated using the Hadlock formula from measurements of the fetal abdominal circumference, femur length and head circumference. This is then plotted onto customised growth chart. Fetal growth restriction is diagnosed antenatally when the estimated fetal weight is under the 3rd centile or under the 10th centile in the presence of abnormal ultrasound dopplers. Abnormal ultrasound dopplers are defined as raised pulsatility index in the fetal umbilical artery, middle cerebral artery or ductus venosus. At birth, fetal growth restriction is diagnosed when the measured birthweight plots under the 10th centile on the customised growth chart.
次要结局
- Intrapartum or immediate postpartum complications.(From the onset of active labour (4cm cervical dilatation and regular contractions of 3-4:10 minutes) till 48 hours post-delivery)
- Persistence of maternal haemodynamic changes(6-12 weeks postpartum (during study visit 4))
- Pregnancy outcome(From birth to 12 weeks of age)
- Gestational age at delivery(At delivery)
- Birthweight centile(At birth)
- Duration of neonatal unit admission(At delivery)
研究者
Dr Nadiah Hashim Arrifin
Fetal Medicine Clinical Research Fellow
Sandwell & West Birmingham Hospitals NHS Trust