PREMOM II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,095
- 试验地点
- 10
- 主要终点
- velocity index (1/1,000/s)
研究概览
简要总结
The goal of this project is thoroughly evaluate the added value of telemonitoring (TM) program for women at risk for gestational hypertensive disorders (GHD), by investigating it impact on prenatal follow-up, health outcomes for mother and child, costs and satisfaction, and by specifically investigating what are the major contributors to this added value.
A substudy (CAPROM) will be conducted at the Department of Obstetrics & Gynecology at Ziekenhuis Oost-Limburg (ZOL) in collaboration with the Department of Physiology of Hasselt University in the framework of the Limburg Clinical Research Center (LCRC). CAPROM aims at evaluating the relationship between longitudinal (clinical) blood pressure measurements and changes in (subclinical) cardiovascular (CV) hemodynamics throughout pregnancy, as well as their responses to antihypertensive medication. To this end, CV profiling will be performed longitudinally on pregnant women at risk for developing GHD being included in the TM group of the PREMOM II study (group 1) or being followed-up via TM as part of their usual care (group 2). A separate ICF is signed for inclusion in the CAPROM substudy. The results of the CAPROM study will be performed by a researcher who is not involved in the PREMOM II main study. In addition, results of the CV profiling will not be communicated to the clinical decision makers of PREMOM II.
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
- 否
入选标准
- •a risk > 1/100 on the Fetal Medicine Foundation (FMF) tool, which is used from the following website: https://fetalmedicine.org/research/assess/preeclampsia/first-trimester
- •CAPROM substudy: Pregnant women at risk for the development of GHD being followed-up via TM as part of the PREMOM II study (group 1) or usual care (group 2)
排除标准
- •congenital malformations of the newborn,
- •pregnant women who doesn't have a Smartphone,
- •pregnant women < 18 years old,
- •pregnant women who doesn't understand the Dutch/French/English language. -
结局指标
主要结局
velocity index (1/1,000/s)
时间窗: Month 3 to month 9
velocity index (1/1,000/s)
acceleration index (1/100/s²)
时间窗: Month 3 to month 9
acceleration index (1/100/s²)
hospitalization
时间窗: From 32 weeks of gestation until 34 weeks of gestation
Numbers of hospitalization during pregnancy (Numeric. Available by hospital details of every patient who is included in the study. From the moment of hospitalization until the moment of discharge is 1 hospitalization.
Changes in CV physiological parameters - electrocardiogram (ECT) with Doppler ultrasonography
时间窗: Month 3 to month 9
The CV profile assessment consists of a simple, non-invasive method using the ECG with Doppler ultrasonography providing information about arteries and veins
stroke volume
时间窗: Month 3 to month 9
stroke volume (ml)
Gestational age (GA)
时间窗: Throug study completion, from the first contact with the gynaecologist (after fertilization) untill 34 weeks of gestation.
difference of at least 10 days between the TM group and the CC was observed in our pilot studies, and will be used as a clinically relevant difference. An extension of the GA by even one day has a large impact on clinical outcomes for the neonate (both short- as long term). Moreover, the highest cost reductions were obtained in the group that delivered before 34 weeks of GA.
changes in CV physiological parameters - bio impedance
时间窗: Month 3 to month 9
The CV profile assessment consists of a simple, non-invasive method using Bio-Impedance using the Maltron® Bioscan 920-II giving information about the fluid balance.
Arterial parameters - resistivity index of the left and right arcuate arteries
时间窗: Month 3 to month 9
The arterial resistive index is a sonographic index of intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70.
venous parameters - hepatic vein impedance index
时间窗: Month 3 to month 9
ECG-Doppler parameters were impedance index at the level of hepatic veins (HVI) and renal interlobar veins (RIVI) together with venous pulse transit times (VPTT), as well as resistive and pulsatility index, and arterial pulse transit time (APTT) at the level of uterine arcuate arteries.
venous parameters - left and right renal interlobar vein impedance indices
时间窗: Month 3 to month 9
ECG-Doppler parameters were impedance index at the level of hepatic veins (HVI) and renal interlobar veins (RIVI) together with venous pulse transit times (VPTT), as well as resistive and pulsatility index, and arterial pulse transit time (APTT) at the level of uterine arcuate arteries.
cardiac output (l/min)
时间窗: Month 3 to month 9
cardiac output (l/min)
changes in CV physiological parameters - impedance cardiography
时间窗: Month 3 to month 9
The CV profile assessment consists of a simple, non-invasive method using Impedance Cardiography using the Non-Invasive Continuous Cardiac Output (NICCOMO) monitor registering heart parameters
Arterial parameters - pulsatility index
时间窗: Month 3 to month 9
Pulsatility index (PI) is defined as the difference between the peak systolic flow and minimum diastolic flow velocity, divided by the mean velocity recorded throughout the cardiac cycle. It is a non-invasive method of assessing vascular resistance with the use of Doppler ultrasonography.
venous parameters - venous pulse transit time of the hepatic and left and right renal veins
时间窗: Month 3 to month 9
Maternal venous pulse transit times (VPTT) weredefined as the time interval (ms) between the maternalECG P-wave and corresponding Doppler A-wave, correctedfor the duration of the corresponding cardiac cycle
systolic blood pressure
时间窗: Month 3 to month 9
systolic blood pressure (mmHg),
diastolic blood pressure
时间窗: Month 3 to month 9
diastolic blood pressure (mmHg),
Mean arterial blood pressure
时间窗: Month 3 to month 9
Mean arterial blood pressure (mmHg),
Arterial parameters - pulse transit time
时间窗: Month 3 to month 9
The Pulse Transit Method (PTT) as a non-invasive means to track Blood Pressure over a short period of time
Total body water
时间窗: Month 3 to month 9
Total body water (liters)
extracellular water
时间窗: Month 3 to month 9
extracellular water (liters)
intracellular water
时间窗: Month 3 to month 9
intracellular water (liters)
ECW/ICW ratio
时间窗: Month 3 to month 9
ECW/ICW ratio
hear rate (beats/min)
时间窗: Month 3 to month 9
hear rate (beats/min)
total peripheral resistance (dyn·s·cm-5)
时间窗: Month 3 to month 9
total peripheral resistance (dyn·s·cm-5)
次要结局
- number of hospitalizations of the mother at the MIC department(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- number of days admitted to the MIC(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- number of medication adaptations during pregnancy(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- Mode of delivery(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- Number of days admitted to the NIC(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- number of starts/adjustments to the antihypertensive medication(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- number of prenatal consults(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- number of ultrasounds(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- number of CTG's(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- development of gestational hypertensive disorders(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- Onset of delivery(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- Birthweight(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- Apgar at 1' and 5'(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- Admission to the neonatal intensive care (NIC)(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- number of phone calls from the patient to the midwife for medical issues(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- BMQ questionaire(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- Cost for the health care services (HCS)(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- number of phone calls from the patient to the midwife for technical issues(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- number of phone calls from the midwife to the patient for technical issues(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- number of phone calls from the midwife to the patient for medical issues(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- Changes in CV profile throughout pregnancy and in response to medication(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
- ProMAS Questionnaire(during pregnancy from the first consultation until delivery assessed up to 40 weeks)
研究者
Wilfried Gyselaers
Principal Investigator
Hasselt University