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临床试验/NCT05137808
NCT05137808Unknown不适用

A Prospective Cohort Study, Understanding Blood Pressure Changes in the Immediate Twelve Weeks Postpartum for Women Who Had a Hypertensive Disorder in Pregnancy and How Existing Care Pathways Identify and Monitor Women at Risk of Cardiovascular Disease

St George's, University of London1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年5月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Prevalence of persistent hypertension in postpartum period

研究概览

简要总结

Research Question How does maternal blood pressure respond in the postpartum period for women who had a hypertensive disorder in pregnancy?

Aim To evaluate the recovery of maternal blood pressure after a pregnancy affected by new onset hypertension after twenty weeks gestation

Objectives

  • To identify rates of persistent hypertension after pregnancies affected by HDP
  • To assess and compare the accuracy of HBPM against the gold standard of ABPM
  • To assess the maternal acceptance of HBPM and ABPM
  • To explore what CVD-related care information is provided at the 6-8 week GP appointment

详细描述

This research aims to investigate how women's blood pressure responds after birth and assess the time it takes to return to normal ranges. This will be calculated by participants undertaking three consecutive days of home blood pressure monitoring, every fortnight from two until twelve weeks postpartum. At twelve weeks postpartum, women will have a twenty-four ambulatory blood pressure assessment. This will highlight the prevalence of persistent high blood pressure and how often GPs will need to monitor women's blood pressure in the immediate few weeks after birth. Women will be asked to complete a questionnaire after their six to eight week GP appointment, assessing if women recall having their blood pressure checked and/or the risks of heart disease explained to them and if they received any lifestyle advice to reduce these risks. Women will be asked to complete a second questionnaire at twelve weeks postpartum assessing their acceptance and preference of home and twenty four hour blood pressure monitoring. This research aims to identify any gaps in the current care of women in the postnatal period and use this information to provide better quality of care to women so they can lead healthier lives and reduce their risk of heart disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women with a confirmed diagnosis of new onset of high blood pressure after twenty weeks gestation
  • Maternal Age >16 years old
  • Mental capacity to give informed consent
  • Ability to be able to communicate to HCP if their BP range is above target (for example women where English is not their first language).

排除标准

  • Pre-existing hypertension

结局指标

主要结局

Prevalence of persistent hypertension in postpartum period

时间窗: 12 weeks

Blood Pressure expressed as mmHg at twelve weeks postpartum via 24 hour ambulatory blood pressure monitoring.

次要结局

  • Levels of agreement of diastolic and systolic blood pressures between HBPM and ABPM measurements(12 weeks)
  • Identification of women who would benefit from closer BP surveillance(12 weeks)
  • Key time points when BP should be monitored post birth(10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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