Characterization of the Immunological and Vascular Effects of Aspirin in Prevention of Preeclampsia in High-risk Nulliparous Women
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Maternal serum cytokine profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
研究概览
简要总结
Primary outcome
- to identify biological changes in nulliparous women at high risk for preeclampsia defined by combined screening by Fetal Medicine Foundation (FMF)
- to identify biological effects of aspirin in nulliparous women with high risk for preeclampsia
Secondary outcomes include findings of longitudinal development and predictive potential of biological markers associated with high-risk for preeclampsia and aspirin treatment.
The main questions it aims to answer are:
- Is high risk for preeclampsia associated with biological changes during pregnancy?
- How does aspirin modulate the biological changes associated with high risk for preeclampsia?
Nulliparous women will undergo routine clinical care at two regional hospitals with different treatment strategies, and selected to the study in three groups: low risk of preeclampsia, high risk of preeclampsia without aspirin, and high-risk of preeclampsia with aspirin treatment.
详细描述
St. Olavs Hospital offers FMF-screening in week 11-14 and aspirin treatment through the "Implementing Screening for Preeclampsia in Norway With Aspirin Discontinuation at 24-28 Weeks - a Randomized Controlled Trial" (NCT06108947). FMF-screening and aspirin treatment are not part of routine clinical care at Alesund Hospital according to current recommendations from the Norwegian health authorities. Alesund Hospital will therefore perform FMF-screening only to determine the project specific study groups. Researchers will compare the three groups to identify biological changes associated with high risk for preeclampsia and the effect of aspirin.
FMF- screening will be performed in week 11-14 after written, informed consent (approved by the the Regional Committee for Medical and Health Research Ethics in Central Norway (REK-midt), REK 537602). Screening includes patient history, blood pressure, uterine artery mean pulsatile index and serum placenta growth factor (PlGF). Standardized blood pressure will be measured by trained personnel. Ultrasound scans will be performed by FMF certified doctors and midwives working at Alesund Hospital and the Center for Fetal Medicine at St.Olavs Hospital in Trondheim. PlGF in maternal serum will be analyzed with Roche or Kryptor technology.
The investigators will include around 200 women, 18 years or older, with a singleton live fetus, in three groups:
- Nulliparous women with low risk for preeclampsia (at both hospitals)
- Nulliparous women with high risk for preeclampsia without aspirin (at Alesund Hospital)
- Nulliparous women with high risk for preeclampsia with aspirin (at St. Olavs Hospital)
Follow-up: all three groups will have visits in week 22-24, 32 and 38, and standard antenatal care after 37 weeks until delivery. Fetal growth and Doppler will be assessed at the scheduled visits and according to clinical judgement by obstetricians at the outpatient clinic of the hospital. Women will have follow-up 6 months after birth.
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
- •18 years or older
- •nulliparous women
- •singleton live fetus
- •FMF risk > 1/100 (high risk), or < 1/150 (low risk)
排除标准
- •not speaking Norwegian or English language
- •fetal anomalies diagnosed with ultrasound
结局指标
主要结局
Maternal serum cytokine profile in week 11-13, 22-24, 32 and 38 and 6 months post partum
时间窗: December 2028
Significant difference between high-risk pregnancies with and without aspirin
次要结局
- Maternal vascular malperfusion in the placenta(December 2028)
- Maternal serum metabolite profile in week 11-13, 22-24, 32 and 38 and 6 months post partum(December 2028)
- Fetal cord serum lipid profile(December 2028)
- Maternal serum lipid profile in week 11-13, 22-24, 32 and 38 and 6 months post partum(December 2028)
- Fetal cord serum cytokine profile(December 2028)
- Fetal vascular malperfusion in the placenta(December 2028)
- Fetal cord serum metabolite profile(December 2028)