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

NCT03334149 | Completed DMC

• 1 other identifier: 224978
• Study Type: interventional
• Target: 3,042
• Locations: 1 country
• Sites: 13

Brief Summary

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. 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. 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. 3.Assess if self-monitoring is cost-effective.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (25)

• Severe hypertension

  From study entry to delivery i.e. up to 40 weeks

• Serious maternal complications

  From study entry to delivery i.e. up to 40 weeks

• Onset of labour

  At delivery

• Assessment of quality of life differences between arms

  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

  From study entry to 8 weeks postpartum i.e. up to 48 weeks

Study Arms (2)

Self-Monitoring of Blood Pressure

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Women randomised to usual care will continue to have all their BP monitoring completed by the clinical team at their antenatal assessments.

Interventions

Self-Monitoring of Blood Pressure OTHER

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.

Self-Monitoring of Blood Pressure

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Chronic Hypertension
• BUMP 2:
• 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.
• 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.
• Anticipated inpatient admission considered likely to lead to imminent delivery (within the next 48 hours)

Sponsors & Collaborators

• University of Oxford: lead
• King's College London: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• University of Southampton: collaborator
• University of Birmingham: collaborator
• Barts & The London NHS Trust: collaborator
• City, University of London: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (13)

Buckinghamshire Healthcare NHS Trust

Aylesbury, HP21 8AL, United Kingdom

Location

Birmingham Women's and Children's Hospital NHS Foundation Trust

Birmingham, B15 2TG, United Kingdom

Location

Croydon Health Services NHS Trust

London, CR7 7YE, United Kingdom

Location

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Kingston Hospital NHS Foundation Trust

London, KT2 7QB, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Chelsea and Westminster Hospital NHS Foundation Trust

London, SW10 9NH, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, OX6 2GG, United Kingdom

Location

The Royal Berkshire NHS Foundation Trust

Reading, RG1 5AN, United Kingdom

Location

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 31980512 BACKGROUND

• 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.

  PMID: 35503346 RESULT

• 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.

  PMID: 35503345 RESULT

• 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.

  PMID: 38258566 DERIVED

• 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.

  PMID: 33262186 DERIVED

• 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.

  PMID: 32748394 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension; Hypertension, Pregnancy-Induced

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Richard J McManus, PhD MBBS

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 7, 2017
• Study Start: November 22, 2017
• Primary Completion: September 16, 2020
• Study Completion: September 16, 2020
• Last Updated: June 6, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: from 31st May 2023
• 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.

Locations

GB (13)