Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension

Conditions
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Pregnancy, High Risk, Pre-Eclampsia, Hypertension, Hypertension, Pregnancy-Induced

Intervention / Treatment
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* Other: Self-Monitoring of Blood Pressure


Participation Criteria
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Eligibility Criteria
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BUMP 1 Inclusion Criteria: 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) Exclusion Criteria: Chronic Hypertension BUMP 2: Inclusion Criteria: • Women developing pregnancy hypertension previously randomised in BUMP 1 (regardless of gestation). OR 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. OR 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. AND 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Note Women in BUMP 1 will transfer to BUMP 2 if they develop hypertension. Women in BUMP 2 can be randomised de novo or join from BUMP 1 maintaining their original randomisation. The enrolment number below therefore includes BUMP 1 (2262) plus BUMP 2 (512). Permission was granted by the ethics committee to continue recruitment passed the original sample size until the original planned end of recruitment date.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Monitoring of Blood Pressure<br>BUMP 1: using a validated home blood pressure monitor at least 3 times a week to record blood pressure BUMP 2: using a validated home blood pressure monitor daily to record blood pressure Women in the intervention groups will be encouraged to use a simple mobile tele monitoring system. | Other: Self-Monitoring of Blood Pressure<br>* BUMP 1: Women randomised to the self-monitoring arm will be asked to measure blood pressures at least three times a week. They will perform two readings with a one minute interval and will be asked to act on the second reading if it falls outside their normal range thresholds described in their instructions, and aided by the tele monitoring system. BUMP 2: Women randomised to the self-monitoring arm will be asked to measure blood pressures daily. They will perform two readings with a one minute interval and will be asked to act on the second reading if it falls outside their normal range thresholds described in their instructions, aided by a tele monitoring system.<br>|
| No Intervention: Usual Care<br>Women randomised to usual care will continue to have all their BP monitoring completed by the clinical team at their antenatal assessments. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from recruitment to diagnosis of raised blood pressure | Difference between groups in time from recruitment to recording of raised blood pressure by health care professional. | From study entry to delivery i.e. up to approximately 25 weeks from recruitment | 
| Mean systolic blood pressure | Difference in mean systolic blood pressure between usual care and self-monitoring group. | From study entry to delivery i.e. up to 40 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe hypertension | Difference between usual care and self-monitoring group in severe hypertension (systolic BP ≥160mmHg and/or or diastolic BP ≥110mmHg) (BUMP 1 and BUMP 2) | From study entry to delivery i.e. up to 40 weeks | 
| Serious maternal complications | Difference between usual care and self-monitoring group in serious maternal complications (pre-eclampsia, placental abruption, transient ischemic attack or stroke, pulmonary oedema, renal failure, blood transfusion), death (BUMP 1 and BUMP 2) | From study entry to delivery i.e. up to 40 weeks | 
| Onset of labour | Difference between usual care and self-monitoring group in onset of labour (BUMP 1 and BUMP 2) | At delivery | 
| Assessment of quality of life differences between arms | Difference between usual care and self-monitoring group in change in quality of life (measured using the EQ-5D-5L) (BUMP 1 and BUMP 2) | From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy | 
| Assessment of quality of life differences between arms | Difference between usual care and self-monitoring group in change in quality of life (measured using the EQ-5D-5L (BUMP 1 and BUMP 2) | From study entry to 8 weeks postpartum i.e. up to 48 weeks | 
| Stillbirth | Difference between usual care and self-monitoring group in number of stillbirths (BUMP 1 and BUMP 2) | At delivery | 
| Early neonatal deaths | Difference between usual care and self-monitoring group in number of early neonatal deaths (BUMP 1 BUMP 2) | From delivery up to 28 days postpartum i.e. up to 4 weeks | 
| Gestation at delivery | Difference between usual care and self-monitoring group in gestation at delivery (BUMP 1 and BUMP 2) | At delivery | 
| Mode of delivery | Difference between usual care and self-monitoring group in mode of delivery (BUMP 1 and BUMP 2) | At delivery | 
| Birth weight including centile | Difference between usual care and self-monitoring group in birth weight of the baby including centile (BUMP 1 and BUMP 2) | At delivery | 
| Small for gestational age infants | Difference between usual care and self-monitoring group in number of small for gestational age infants (<10th and <3rd centile) (BUMP 1 and BUMP 2) | At delivery | 
| Neonatal unit admissions | Difference between usual care and self-monitoring group in number of neonatal unit admissions including length of stay (BUMP 1 and BUMP 2) | From delivery up to 28 days postpartum i.e. up to 4 weeks | 
| Health behaviours | Difference between usual care and self-monitoring group in change in health behaviours (questionnaire) (BUMP 1 and BUMP 2) | From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy. | 
| Health behaviours | Difference between usual care and self-monitoring group in change in health behaviours (questionnaire) (BUMP 1 and BUMP 2) | From study entry to 8 weeks postnatal i.e. up to 48 weeks | 
| Fidelity to monitoring schedule | Difference between usual care and self-monitoring group in fidelity to monitoring schedule (BUMP 1 and BUMP 2) | From study entry to delivery i.e. up to 48 weeks | 
| STAI-6 short form anxiety questionnaire | Difference between usual care and self-monitoring group in change in State trait anxiety inventory short form anxiety questionnaire (STAI-6 ) (BUMP 1 and BUMP 2) | From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy. | 
| STAI-6 short form anxiety questionnaire | Difference between usual care and self-monitoring group in change in STAI-6 short form anxiety questionnaire (BUMP 1 and BUMP 2) | From study entry to 8 weeks postnatal i.e. up to 48 weeks | 
| Health service costs | Difference between usual care and self-monitoring group in health service costs. (BUMP 1 and BUMP 2) | From study entry to delivery i.e. up to 40 weeks | 
| Cost per quality-adjusted life year gained over trial period | Difference between usual care and self-monitoring group in cost per quality-adjusted life year gained over trial period (BUMP 1 and BUMP 2) | From study entry to delivery i.e. up to 40 weeks | 
| Qualitative | Qualitative data gathered from participating women and healthcare professionals (BUMP 1 and BUMP 2) | From study entry to 8 weeks postpartum i.e. up to 48 weeks | 
| Mean diastolic blood pressure | Difference between usual care and self-monitoring group in mean diastolic blood pressure (BUMP 2) | From study entry to delivery i.e. up to 40 weeks | 
| Mean area under the blood pressure over time curve | Difference between usual care and self-monitoring group in mean area under the blood pressure curve (BUMP 2) | From study entry to delivery i.e. up to 40 weeks | 
| Mean proportion of readings above 140mmHg | Difference between usual care and self-monitoring group in mean proportion of readings above 140mmHg (BUMP 2) | From study entry to delivery i.e. up to 40 weeks | 
| Adherence to medication | Difference between usual care and self-monitoring group in change in adherence to medication (MARS) (BUMP 2) | From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy. | 
| Adherence to medication | Difference between usual care and self-monitoring group in change in adherence to medication (MARS) (BUMP 2) | From study entry to 8 weeks postnatal i.e. up to 48 weeks |