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

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:

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Pregnancy, High Risk; Pre-Eclampsia; Hypertension, Pregnancy-Induced
• Intervention / Treatment: Other: Self-Monitoring of Blood Pressure

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 3042
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Aylesbury, United Kingdom, HP21 8AL
    • Buckinghamshire Healthcare NHS Trust
  • Birmingham, United Kingdom, B15 2TG
    • Birmingham Women's and Children's Hospital NHS Foundation Trust
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust
  • London, United Kingdom, SE1 7EH
    • Guy's and St Thomas' NHS Foundation Trust
  • London, United Kingdom, E1 1BB
    • Barts Health NHS Trust
  • London, United Kingdom, SW10 9NH
    • Chelsea and Westminster Hospital NHS Foundation Trust
  • London, United Kingdom, CR7 7YE
    • Croydon Health Services NHS Trust
  • London, United Kingdom, KT2 7QB
    • Kingston Hospital NHS Foundation Trust
  • London, United Kingdom, SW17 0QT
    • St George's University Hospitals NHS Foundation Trust
  • Manchester, United Kingdom, M13 9WL
    • Manchester University NHS Foundation Trust
  • Oxford, United Kingdom, OX6 2GG
    • Oxford University Hospitals NHS Foundation Trust
  • Reading, United Kingdom, RG1 5AN
    • The Royal Berkshire NHS Foundation Trust
  • Wolverhampton, United Kingdom, WV10 0QP
    • The Royal Wolverhampton NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: Usual Care; 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?

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

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: King's College London; University of Southampton; Barts & The London NHS Trust; University of Birmingham; National Institute for Health Research, United Kingdom; City, University of London; Oxford University Hospitals NHS Trust
• Investigators: Principal Investigator: Richard J McManus, PhD MBBS, University of Oxford

Publications and helpful links

General Publications

• 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. Erratum In: BMJ Open. 2020 Aug 27;10(8):e034593corr1.
• 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. Erratum in: JAMA. 2022 Jul 12;328(2):217.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2017
• Primary Completion (Actual): September 16, 2020
• Study Completion (Actual): September 16, 2020

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 224978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data are available from the authors upon reasonable request and with permission of the University of Oxford. Use of data will require approval by an independent review committee identified for this purpose and investigators requesting data will need to provide a written protocol including analysis plan and sign a data sharing/access agreement. Requests for Data Sharing should be directed to information.guardian@phc.ox.ac.uk.
• IPD Sharing Time Frame: from 31st May 2023
• IPD Sharing Access Criteria: Use of data will require approval by an independent review committee identified for this purpose and investigators requesting data will need to provide a written protocol including analysis plan and sign a data sharing/access agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No