Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
NCT ID: NCT03334149
Last Updated: 2022-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3042 participants
INTERVENTIONAL
2017-11-22
2020-09-16
Brief Summary
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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:
1. 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.
2. Compare self-monitoring with usual care for women with high blood pressure in pregnancy to see if it leads to lower blood pressure.
3. 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Self-Monitoring of Blood Pressure
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.
Self-Monitoring of Blood Pressure
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.
Usual Care
Women randomised to usual care will continue to have all their BP monitoring completed by the clinical team at their antenatal assessments.
No interventions assigned to this group
Interventions
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Self-Monitoring of Blood Pressure
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
• 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
BUMP 2:
Anticipated inpatient admission considered likely to lead to imminent delivery (within the next 48 hours)
18 Years
FEMALE
Yes
Sponsors
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King's College London
OTHER
Oxford University Hospitals NHS Trust
OTHER
University of Southampton
OTHER
University of Birmingham
OTHER
Barts & The London NHS Trust
OTHER
City, University of London
OTHER
National Institute for Health Research, United Kingdom
OTHER_GOV
University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Richard J McManus, PhD MBBS
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Buckinghamshire Healthcare NHS Trust
Aylesbury, , United Kingdom
Birmingham Women's and Children's Hospital NHS Foundation Trust
Birmingham, , United Kingdom
Croydon Health Services NHS Trust
London, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Kingston Hospital NHS Foundation Trust
London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, , United Kingdom
St George's University Hospitals NHS Foundation Trust
London, , United Kingdom
Manchester University NHS Foundation Trust
Manchester, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
The Royal Berkshire NHS Foundation Trust
Reading, , United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton, , United Kingdom
Countries
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References
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Dougall G, Franssen M, Tucker KL, Yu LM, Hinton L, Rivero-Arias O, Abel L, Allen J, Band RJ, Chisholm A, Crawford C, Green M, Greenfield S, Hodgkinson J, Leeson P, McCourt C, MacKillop L, Nickless A, Sandall J, Santos M, Tarassenko L, Velardo C, Wilson H, Yardley L, Chappell L, McManus RJ. Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials. BMJ Open. 2020 Jan 23;10(1):e034593. doi: 10.1136/bmjopen-2019-034593.
Tucker KL, Mort S, Yu LM, Campbell H, Rivero-Arias O, Wilson HM, Allen J, Band R, Chisholm A, Crawford C, Dougall G, Engonidou L, Franssen M, Green M, Greenfield S, Hinton L, Hodgkinson J, Lavallee L, Leeson P, McCourt C, Mackillop L, Sandall J, Santos M, Tarassenko L, Velardo C, Yardley L, Chappell LC, McManus RJ; BUMP Investigators. Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial. JAMA. 2022 May 3;327(17):1656-1665. doi: 10.1001/jama.2022.4712.
Chappell LC, Tucker KL, Galal U, Yu LM, Campbell H, Rivero-Arias O, Allen J, Band R, Chisholm A, Crawford C, Dougall G, Engonidou L, Franssen M, Green M, Greenfield S, Hinton L, Hodgkinson J, Lavallee L, Leeson P, McCourt C, Mackillop L, Sandall J, Santos M, Tarassenko L, Velardo C, Wilson H, Yardley L, McManus RJ; BUMP 2 Investigators. Effect of Self-monitoring of Blood Pressure on Blood Pressure Control in Pregnant Individuals With Chronic or Gestational Hypertension: The BUMP 2 Randomized Clinical Trial. JAMA. 2022 May 3;327(17):1666-1678. doi: 10.1001/jama.2022.4726.
Campbell HE, Chappell LC, McManus RJ, Tucker KL, Crawford C, Green M, Rivero-Arias O. Detection and Control of Pregnancy Hypertension Using Self-Monitoring of Blood Pressure With Automated Telemonitoring: Cost Analyses of the BUMP Randomized Trials. Hypertension. 2024 Apr;81(4):887-896. doi: 10.1161/HYPERTENSIONAHA.123.22059. Epub 2024 Jan 23.
Hinton L, Hodgkinson J, Tucker KL, Rozmovits L, Chappell L, Greenfield S, McCourt C, Sandall J, McManus RJ. Exploring the potential for introducing home monitoring of blood pressure during pregnancy into maternity care: current views and experiences of staff-a qualitative study. BMJ Open. 2020 Dec 1;10(12):e037874. doi: 10.1136/bmjopen-2020-037874.
Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.
Other Identifiers
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224978
Identifier Type: -
Identifier Source: org_study_id
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