Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) - a Randomised, Placebo-controlled, Double-blind Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- UMC Utrecht
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Development of pregnancy-induced hypertension (PIH) in pregnancy
研究概览
简要总结
Hypertensive disorders of pregnancy (HDP) are with 50.000 deaths every year one of the major causes of maternal mortality worldwide, especially in low and middle income countries. This trial aims to determine whether a daily dose of combined low-dose aspirin, calcium, vitamin D3, folic acid and vitamin B12 in pregnancy reduces the incidence of pregnancy-induced hypertension in women at risk. Secondary and tertiary objectives include other maternal and neonatal outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •<16 weeks of gestation and over 18 years of age,
- •Intention to have subsequent antenatal visits and delivery at the same clinic.
- •Can receive text messages by phone or through the phone of a proxy.
- •A moderate to high risk (>20%) of developing PIH
排除标准
- •Pre-existing hypertension or hypertension before 20 weeks gestation.
- •Likely non-compliance with the protocol in view of the treating physician
- •Comorbidity interfering with the protocol
- •Known contraindications to Investigational Product components
研究组 & 干预措施
Combined aspirin and multinutrient supplement
In a single capsule, the following will be combined: 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12
干预措施: Combined aspirin and multinutrient supplement (Drug)
Combined aspirin and multinutrient supplement
In a single capsule, the following will be combined: 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12
干预措施: Daily text reminder text messages (Other)
Placebo
5mg folic acid, cellulose filler
干预措施: Daily text reminder text messages (Other)
结局指标
主要结局
Development of pregnancy-induced hypertension (PIH) in pregnancy
时间窗: up to 2 days after delivery.
Development of a de novo systolic blood pressure (SBP) of \> 140 mmHg, diastolic blood pressure (DBP) of \>90 mmHg, measured at least twice.
次要结局
- Maternal/obstetric outcomes(6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after)
- Number of participants with (severe) adverse events as a measure of safety and tolerability(1 year)
- Neonatal and infant outcomes(6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after)
研究者
Joyce L. Browne
MD, MSc,PhD candidate
UMC Utrecht