Automatic Blood Pressure Assessment in Waiting Room During Pregnancy Compare to 24-h Ambulatory Blood Pressure Measurement
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 659
- 主要终点
- Differences in Blood Pressure between office and 24- Ambulatory Blood Pressure Meassurement (24-h ABPM)
研究概览
简要总结
The goal of this observational study is to compare in healthy pregnant women during the first trimester. The main question it aims to answer are:
Accuracy of measuring automatically Blood Pressure (BP) at appointment compared to 24 Hour Ambulatory Blood Pressure Monitor (ABPM).
Participants will be BP measured with homologated device every 3 minutes in waiting room for 20 minutes.
Researchers will compare Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in clinical visit to see if are comparable to ABPM.
详细描述
659 pregnant women will be recruitment if they In with SBP readings above 130 mmHg in office or the presence of a risk factor for eclampsia: (hypertensive disease in previous pregnancy, chronic hypertension, chronic renal disease, diabetes mellitus, or autoimmune disease) or any two moderate-risk factors (nulliparity, age ≥40 years, BMI ≥35 kg/m2, family history of PE, or interpregnancy interval >10 years).
Measured of BP will be performance in waiting room for 20 minutes every 3 minutes and report by an mobile app. After 24h-ABPM device will be implanted. Results of SBP and DBP obtained in office will be compared with 24-h, diurnal and nocturnal SBP/DBP mean.
BP will be measured automatically and repeatedly every 3 minutes in the waiting room for 20 minutes. Subsequently, a SpaceLab ABPM monitor will be implanted. The SBP and DBP results obtained in the waiting room will be compared with the ABPM results.
Clinical data related to eclampsia and maternal and newborn pregnancy outcomes will be collected from all patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Woman during the first 12 weeks of pregnancy Maternal age>35 Nulliparity Previous history of hypertension Short and long interpregnancy interval Use of assisted reproductive technologies Family history of preeclampsia Obesity. BMI>
- •Hyperglycemia Renal disease
排除标准
- •Any inability to perform 24-h ambulatory BP measurement
结局指标
主要结局
Differences in Blood Pressure between office and 24- Ambulatory Blood Pressure Meassurement (24-h ABPM)
时间窗: 10 mounths
Concordance of Systolic and Diastolic Blood Pressure mean between waiting room and 24-h ABMP measurements
Maternal
时间窗: 10 months
Cardiovascular events, preeclampsia, abruptio, cesarean delivery, hemorrhage,pulmonary edema, death
Newborn
时间窗: 10 monts
Growth restriction, preterm delivery, congenital anomalies, stillbirth, neonatal death.
次要结局
未报告次要终点