Fetal Growth and Pregnancy Complications Among Women With Heart Disease in Norway: a Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Fetal growth
研究概览
简要总结
An increasing proportion of women with heart disease now go through pregnancy and childbirth. More knowledge about the risk of complications and adverse outcomes for the mother and the baby is needed to guide clinical care in this diverse patient group.
The purpose of this study is to, in a cohort of pregnant women with heart disease;
- determine fetal growth, and risk of fetal growth restriction and preterm birth
- determine whether maternal blood biomarkers are associated with development of preeclampsia, the time of delivery and maternal and perinatal adverse outcomes
- determine the risk of hypertensive pregnancy complications
The expected outcome of the project is to increase the knowledge of optimal diagnosis and treatment of women with heart disease that go through pregnancy to be able to improve clinical care and the outcomes for mother and baby.
详细描述
Heart disease is about to become the most important cause of maternal deaths in industrialized countries. In addition, heart disease in pregnancy is associated to an increased rate of fetal growth restriction, premature birth, preeclampsia and other pregnancy complications for the mother and the baby. As many women with congenital or acquired heart disease now go through pregnancy and childbirth, more knowledge about the risk of complications and adverse outcomes for the mother and the baby is needed to guide clinical care in this diverse patient group.
The National Unit for Pregnancy and Heart Disease is located at Oslo University Hospital, Rikshospitalet, and receive moderate and high risk pregnant women as referrals from hospitals nationwide for follow-up and treatment. The unit has established Oslo University Hospital Register for Pregnancy and Heart disease; a quality register for maternal and fetal outcome in women with heart disease.
The purpose of this study was therefore to, in a cohort of pregnant women with heart disease;
- determine fetal growth, and risk of fetal growth restriction and preterm birth
- determine whether maternal blood biomarkers are associated with development of preeclampsia, the time of delivery and maternal and perinatal adverse outcomes
- determine the risk of hypertensive pregnancy complications
By the next two years, 150 patients will be included in two prospective longitudinal studies. In the first study fetal growth and utero-placental-fetal blood flow will be assessed by serial measurements at specific gestational ages. The mother's cardiac function will also be measured. Primary outcome is fetal growth curve and wellbeing at birth.
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pregnant women diagnosed with heart disease before or during pregnancy classified as maternal WHO risk class 2-4
排除标准
- •Non-consent
结局指标
主要结局
Fetal growth
时间窗: From gestational week 12 until time of birth of baby
Serial measurements of fetal biometry
Occurrence of hypertension/preeclampsia in pregnancy or postpartum
时间窗: From time of study inclusion until time of discharge from maternity unit after birth of baby
Diagnosis in index pregnancy or postpartum until discharge from maternity unit
Fetoplacental circulation
时间窗: From gestational week 12 until time of birth of baby
Serial measurements of fetoplacental circulation
次要结局
未报告次要终点
研究者
Ingvil Krarup Sørbye
Consultant OBGYN, MD PhD
Oslo University Hospital