Implementing Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of patients with preterm preeclampsia
研究概览
简要总结
Study population Around 3500 pregnant women attending a routine ultrasound scan at 11-14 weeks at St. Olavs hospital, Trondheim, Norway.
Study period Dec 2023 - Jul 2025
Screening Patient history, blood pressure, uterine artery mean PI and PlGF will be plotted in the FMF algorithm for screening for preeclampsia in the first trimester. Standardized blood pressure will be measured by trained personnel. Ultrasound scans will be performed by FMF certified doctors and midwives working at the Center for Fetal Medicine in Trondheim. Placenta growth factor (PLGF) will be analyzed with Kryptor technology at Center for Laboratory Medicine, St. Olavs hospital.
Prophylaxis Women with high risk for preterm preeclampsia (risk > 1:100) will be offered aspirin prophylaxis 150 mg x 1 from 11-14 weeks to 36 weeks. Women will be offered to participate in a randomized controlled trial (RCT).
Study design and participants in the RCT A single center, open label, randomized, noninferiority trial conducted at St. Olavs hospital, Trondheim Norway from Dec 2023 to Jul 2025. The investigators will include around 300 women 18 years or older with a singleton live fetus, gestational age between 24 and 28 weeks, high risk of preterm preeclampsia (>1/100) in the first trimester screening, aspirin treatment with a dose 150 mg per day initiated at 16+6 weeks of gestation or less until randomization with a adherence of at least 50% and low SFlt-1/PlGF ratio (Kryptor technology with cut-off 66).
Randomization and masking Between 24 and 28 weeks of gestation, participants will be randomly designed, with a computer-based system in a 1:1 ratio, to continue aspirin (control group) or discontinue aspirin (intervention group). This is an open-label study without masking of patients or providers.
Follow-up Both groups will have visits every 4 weeks between randomization and 36 weeks, and standard antenatal care after 37 weeks until delivery. Treatment adherence will be assessed by patient self-report and tablet count, and fetal growth and Doppler will be assessed at the scheduled visits between randomization and 36 weeks (at 24, 28, 32 and 36 weeks), and according to clinical judgement by obstetricians at the outpatient clinic of the hospital. Women will have a telephone/video link follow-up 1-2 months after birth
详细描述
The implementation study is divided into four parts/study questions
- Is screening for preeclampsia cost-effective in a Norwegian setting?
Folkehelseinstituttet (FHI) in Norway has done a health technology assessment including a cost-effectiveness analysis of introducing screening for preeclampsia at 11-14 weeks in Norway. FHI concluded that 173 cases of preterm preeclampsia could be prevented annually in Norway, and that 17 MNOK could be saved every year. Calculations were based on data from the Norwegian Medical Birth Registry. In this analysis the estimated extra time for measuring the mean uterine artery PI and calculating individual risk was set to 15 min, and costs for analyzing blood samples were set to 600 NOK per woman.
The present study will assess if the estimated prerequisites in the FHI cost-effectiveness analysis are correct in a clinical setting. The investigators will register time during ultrasound scans and time used for calculating risks and informing patients. Costs for laboratory analyses will be studied. A new cost-effectiveness analysis will be performed if the prerequisites in the previous analysis are far from the ones collected from a clinical setting. 2. Is the blood pressure measured at the general practioner's (GP's) office equivalent to standardized measured BP at the hospital?
Norwegian women are offered a visit at the GP's office around pregnancy week 8-12. At this visit women are given general information, BP is measured, and blood samples are drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •18 years or older
- •singleton live fetus with gestational age between 24 and 28 weeks
- •woman with high risk of preterm preeclampsia (>1/100) in the first trimester screening
- •aspirin treatment with a dose 150 mg per day initiated at 16+6 weeks of gestation or less until randomization with adherence of at least 50%
- •low SFlt-1/PlGF ratio (Kryptor technology with cut-off 66) measured at 24-28 weeks
排除标准
- •not speaking Norwegian or English language
- •fetal anomalies diagnosed with ultrasound
- •informed consent for participation in the trial
研究组 & 干预措施
Aspirin
Aspirin 150 mg per day from pregnancy week 12 to 36 - according to current recommendations
干预措施: Aspirin (Drug)
Aspirin discontinuation
Discontinuation of Aspirin around 24-28 weeks in low risk women
干预措施: Aspirin (Drug)
结局指标
主要结局
Number of patients with preterm preeclampsia
时间窗: Pregnancy week 24 to pregnancy week 37
Delivery due to preeclampsia before 37 weeks of gestation
次要结局
- Number of patients with preeclampsia before 34 weeks(Pregnancy week 24 to pregnancy week 34)
- Number of patients with preeclampsia after 37 weeks(Pregnancy week 24 to pregnancy week 42)
- Number of patients developing severe gestational hypertension(Pregnancy week 24 to pregnancy week 42)
- Number of patients diagnosed as small for gestational age (10th centile)(Birthweight at delivery between 24 and 42 weeks)
- Number of patients diagnosed as small for gestational age (3rd centile)(Birthweight at delivery between 24 and 42 weeks)
- Number of patients diagnosed with placental abruption(Delivery between 24 and 42 weeks)
- Number of patients with spontaneous preterm delivery(Delivery between 24 and 42 weeks)
- Number of patients with mild post partum hemorrhage(Delivery between 24 and 42 weeks)
- Number of patients with severe post partum hemorrhage(Delivery between 24 and 42 weeks)
- Number of patients with antenatal bleeding(Pregnancy week 24 to pregnancy week 42)
- Days of antenatal bleeding(Pregnancy week 24 to pregnancy week 42)
- Severity of of antenatal bleeding(Pregnancy week 24 to pregnancy week 42)