Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,042
- 试验地点
- 26
- 主要终点
- Time from recruitment to diagnosis of raised blood pressure
研究概览
简要总结
Raised blood pressure is a common problem in pregnancy. Raised blood pressure and pre-eclampsia affect about one in ten women and are a major cause of death and premature birth in the United Kingdom and worldwide.
Many women have expressed an interest in monitoring their own blood pressure in between antenatal visits but there has been very little research to guide this. The investigators would like to know if the diagnosis and subsequent care of women with raised blood pressure can be improved if women were able to monitor their own blood pressure safely at home. This work will test whether optimising the diagnosis, monitoring and management of raised BP during pregnancy through self-monitoring of BP is effective, acceptable and cost-effective compared to usual care.
The research team have being working with pregnant women, doctors and midwives to develop a simple and accurate method of self-monitoring of blood pressure in pregnancy.
This randomised controlled trial will:
- Compare self-monitoring with usual care in women at higher risk of hypertension in pregnancy and assess if self-monitoring can identify raised blood pressure earlier.
- Compare self-monitoring with usual care for women with high blood pressure in pregnancy to see if it leads to lower blood pressure.
- Assess if self-monitoring is cost-effective.
Pregnant women who chose to take part in these studies will be randomised to either usual care or asked to monitor their own blood pressure during their pregnancy in addition to their usual antenatal care.
详细描述
BUMP 1 will randomise 2262 women at higher risk of hypertension in pregnancy into usual care or self-monitoring.
BUMP 2 will randomise 512 women with hypertension in pregnancy (including chronic hypertension) into usual care or self-monitoring. Women in BUMP 1 will move into BUMP 2 if they develop hypertension.
Women will be recruited at approximately 15 hospitals in England over approximately 24 months.
Women will be recruited from 20 weeks (BUMP 1) or early pregnancy(BUMP 2) and followed up until 2 months after birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the trial
- •Pregnant woman, aged 18 years or above between 16+0 to 24+0 weeks
- •Able and willing to comply with trial requirements
- •Willing to allow her general practitioner and consultant, if appropriate, to be notified of participation in the trial
- •At higher risk for hypertension in pregnancy / pre-eclampsia defined as one or more of the following risk factors:
- •Age 40 years or older
- •Nulliparity
- •Pregnancy interval of more than 10 years
- •Family history of pre-eclampsia
- •Previous history of pre-eclampsia or gestational hypertension
- •Body mass index 30 kg/m2 or above at booking
- •Chronic kidney disease
- •Twin pregnancy
- •Diabetes (Type 1&2)
- •Autoimmune Disease (eg systemic lupus erythematosis or antiphospholipid disease)
排除标准
- •Chronic Hypertension
- •Inclusion Criteria:
- •Women developing pregnancy hypertension previously randomised in BUMP 1 (regardless of gestation).
- •Women with chronic hypertension (defined as sustained systolic BP≥140 mmHg and/or diastolic BP≥90 mmHg, present at booking or before 20 weeks' gestation, or receiving treatment outside pregnancy and/or at time of referral).
- •Recruited up to 37+0 weeks' gestation.
- •Women with hypertension after 20 weeks' gestation (defined as sustained systolic BP≥140 mmHg and/or diastolic BP≥90 mmHg).
- •Recruited at 20+0 to 37+0 weeks' gestation.
- •Participant is willing and able to give informed consent for participation in the trial.
- •Woman aged 18 years or above.
- •Willing to allow her general practitioner and consultant, if appropriate, to be notified of participation in the trial.
- •Exclusion criteria:
- •Anticipated inpatient admission considered likely to lead to imminent delivery (within the next 48 hours)
结局指标
主要结局
Time from recruitment to diagnosis of raised blood pressure
时间窗: From study entry to delivery i.e. up to approximately 25 weeks from recruitment
Difference between groups in time from recruitment to recording of raised blood pressure by health care professional.
Mean systolic blood pressure
时间窗: From study entry to delivery i.e. up to 40 weeks
Difference in mean systolic blood pressure between usual care and self-monitoring group.
次要结局
- Onset of labour(At delivery)
- Early neonatal deaths(From delivery up to 28 days postpartum i.e. up to 4 weeks)
- Mean proportion of readings above 140mmHg(From study entry to delivery i.e. up to 40 weeks)
- Assessment of quality of life differences between arms(From study entry to 8 weeks postpartum i.e. up to 48 weeks)
- Fidelity to monitoring schedule(From study entry to delivery i.e. up to 48 weeks)
- Cost per quality-adjusted life year gained over trial period(From study entry to delivery i.e. up to 40 weeks)
- Birth weight including centile(At delivery)
- Neonatal unit admissions(From delivery up to 28 days postpartum i.e. up to 4 weeks)
- Health service costs(From study entry to delivery i.e. up to 40 weeks)
- Qualitative(From study entry to 8 weeks postpartum i.e. up to 48 weeks)
- Severe hypertension(From study entry to delivery i.e. up to 40 weeks)
- Stillbirth(At delivery)
- Gestation at delivery(At delivery)
- Health behaviours(From study entry to 8 weeks postnatal i.e. up to 48 weeks)
- Mean diastolic blood pressure(From study entry to delivery i.e. up to 40 weeks)
- Adherence to medication(From study entry to 8 weeks postnatal i.e. up to 48 weeks)
- Serious maternal complications(From study entry to delivery i.e. up to 40 weeks)
- Mean area under the blood pressure over time curve(From study entry to delivery i.e. up to 40 weeks)
- Mode of delivery(At delivery)
- Small for gestational age infants(At delivery)
- STAI-6 short form anxiety questionnaire(From study entry to 8 weeks postnatal i.e. up to 48 weeks)