Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 9
- 主要终点
- Hypertension specific intervention
研究概览
简要总结
The occurrence of arterial hypertension (AH) during pregnancy is a major cause of fetal, neonatal and maternal morbidity and mortality in western countries. It is estimated that about 10% of pregnancies are complicated by AH (80 000 women / year in France). It is therefore essential to diagnose AH with certainty in order to set-up appropriate care and follow its evolution.
详细描述
The objective of this study is to show the faisability of self-measurement with teletransmission for long-term follow-up of hypertensive pregnant women (at high risk of preeclampsia) by avoiding repeated, prolonged visits or hospitalizations and to optimize the intervention of health professionals by providing them with reliable data.
A multicenter, controlled study will be conducted in women presenting with mild to moderate hypertension without preeclampsia followed throughout their pregnancy by either self-measurement with teletransmission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Pregnant women with confirmed mild to moderate AH untreated and / or under antihypertensive treatment (for gestational or chronic hypertension)
- •Women without preeclampsia requiring enhanced AH surveillance
- •Patient affiliated to a social security system
- •Patient giving consent to participate in the study.
- •Age> 18 years
排除标准
- •arm circumference greater than 42 cm unsuitable for self-measurement,
- •women in atrial fibrillation, or frequently in arrhythmia, with secondary hypertension or severe hypertension or with cardiovascular complication.
- •women having preeclampsia.
- •women having an AH by "white coat effect".
- •women having a move or maternity change planned during pregnancy.
- •majors protected under tutorship or curatorship, or under the protection of justice.
结局指标
主要结局
Hypertension specific intervention
时间窗: Through study completion, an average of 9 months
Percentage of blood pressure measurements initially planned and actually performed during the course of the investigation
次要结局
- Number of blood pressure measurements per day and per week(Through study completion, an average of 9 months)
- Likert scale to assess medical staff's satisfaction(Through study completion, an average of 9 months)
- Likert scale to assess patients' satisfaction(Through study completion, an average of 9 months)