Prevention of Preeclampsia in Denmark (PREPRED): A National Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80,000
- 试验地点
- 3
- 主要终点
- Incidence of Preterm Preeclampsia (<37 Weeks' Gestation)
研究概览
简要总结
The goal of this clinical study is to learn if a new first-trimester screening program can better find pregnant women who are at high risk of developing preeclampsia and help prevent the condition with early treatment.
Preeclampsia is a pregnancy condition that causes high blood pressure and can affect the mother's organs and the baby's growth. Early detection allows doctors to offer preventive treatment, such as low-dose aspirin, which may lower the risk of serious illness.
The study includes pregnant women with a single pregnancy who attend their routine first-trimester scan at maternity hospitals in Denmark.
The main questions it aims to answer are:
Does the new screening program lower the number of women who develop preterm preeclampsia (preeclampsia before thirty-seven weeks of pregnancy)?
Can the screening program be carried out safely and be acceptable for pregnant women and healthcare professionals?
Researchers will gradually introduce the new screening program across hospitals and compare outcomes before and after the program starts. Women who are found to have a high risk of preeclampsia will be offered preventive treatment with low-dose aspirin.
Participants will:
Receive information about preeclampsia and the screening during their first-trimester visit
Have their blood pressure measured and an ultrasound assessment of blood flow to the uterus during the routine scan
Have routine blood samples analysed to estimate their personal risk of preeclampsia
Be offered daily low-dose aspirin until late pregnancy if they are identified as high risk
Continue standard pregnancy care while researchers follow pregnancy outcomes using national health records
The study will help researchers understand whether this screening approach works in everyday care and whether it should become part of routine pregnancy care in Denmark.
详细描述
Rationale
Preeclampsia remains a leading cause of maternal and neonatal complications despite established preventive strategies. Evidence from randomised trials and implementation studies indicates that early identification of women at increased risk, followed by prophylactic low-dose acetylsalicylic acid, can substantially reduce the occurrence of preterm disease. However, risk assessment based solely on maternal characteristics has shown limited performance in routine care settings, resulting in missed opportunities for prevention.
Multivariable first-trimester risk assessment models that combine maternal characteristics with physiological and biochemical markers have demonstrated improved predictive accuracy across diverse populations. The Fetal Medicine Foundation (FMF) model integrates maternal history, mean arterial pressure, uterine artery Doppler indices, placental growth factor, and pregnancy-associated plasma protein-A into an individualized risk estimate. Danish evaluation studies have confirmed the model's predictive performance and feasibility within existing prenatal screening infrastructure, supporting progression from validation to national implementation.
The present study evaluates the real-world introduction of structured first-trimester preeclampsia risk assessment within a healthcare system characterized by universal antenatal care coverage, established first-trimester screening pathways, and comprehensive national registries. The study is designed to generate implementation evidence addressing effectiveness, feasibility, safety, workflow integration, and population reach.
Implementation strategy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with a viable singleton pregnancy
- •Attendance at a routine first-trimester ultrasound scan at 11+0 to 13+6 weeks of gestation at a Danish maternity hospital during the study period
- •Valid Danish personal identification number (CPR number) enabling linkage with national health registries
排除标准
- •Multiple pregnancy (e.g., twins or higher-order gestations)
- •Major fetal anomaly diagnosed before completion of first-trimester screening
- •Miscarriage or pregnancy loss diagnosed before completion of first-trimester screening
结局指标
主要结局
Incidence of Preterm Preeclampsia (<37 Weeks' Gestation)
时间窗: From first-trimester assessment (11-14 weeks' gestation) until delivery
Proportion of pregnancies complicated by preeclampsia with delivery before 37+0 weeks' gestation. Preeclampsia will be defined according to the 2018 International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria. Cases will be identified using mandatory ICD-10 diagnosis codes recorded in the Danish National Patient Register and linked with gestational age at delivery from the Danish Medical Birth Register. The outcome will be assessed at the population level comparing baseline and implementation periods.
次要结局
- Incidence of Early Preeclampsia (<34 Weeks' Gestation)(From first-trimester assessment until delivery.)
- Incidence of Preterm Delivery (<32, <34, and <37 Weeks' Gestation)(Pregnancy through delivery)
- Fetal growth restriction and stillbirth(Pregnancy through delivery.)
- Neonatal Intensive Care Unit (NICU) Admission(At delivery/birth)
- Screening Uptake(Through study completion, an average of 2 years)
- Screen-Positive Rate (High-Risk Classification)(At time of first-trimester screening (11-14 weeks' gestation).)
- Aspirin Prophylaxis Uptake and Adherence(From screening result until 36+0 weeks' gestation or delivery, whichever occurs first.)
- Number of participants with severe postpartum hemorrhage identified using diagnosis and procedure codes in the Danish National Patient Register(From delivery to discharge from the delivery hospitalization)
- Number of participants with placental abruption identified using diagnosis codes in the Danish National Patient Register(From 11+0 weeks of gestation to delivery)
- Number of maternal or neonatal intracranial hemorrhage events identified using diagnosis codes in the Danish National Patient Register(From 11+0 weeks of gestation to discharge from the birth hospitalization)
研究者
Iben Riishede
Principal Investigator
Rigshospitalet, Denmark