Pregnancy, High RiskBUMPNCT03334149
Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
A study testing Self-Monitoring of Blood Pressure in people with Pregnancy, High Risk and Pre-Eclampsia, run by University of Oxford at 13 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, High Risk, Pre-Eclampsia, Hypertension
- What is being tested?
- Self-Monitoring of Blood Pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,042 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- 22 Nov 2017to 16 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 26Show fewer
- 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.
Who cannot join
- Chronic Hypertension
- BUMP 2:
- Anticipated inpatient admission considered likely to lead to imminent delivery (within the next 48 hours)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites
Buckinghamshire Healthcare NHS Trust
Aylesbury, HP21 8AL
Birmingham Women's and Children's Hospital NHS Foundation Trust
Birmingham, B15 2TG
Croydon Health Services NHS Trust
London, CR7 7YE
Barts Health NHS Trust
London, E1 1BB
Kingston Hospital NHS Foundation Trust
London, KT2 7QB
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Chelsea and Westminster Hospital NHS Foundation Trust
London, SW10 9NH
St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Oxford University Hospitals NHS Foundation Trust
Oxford, OX6 2GG
The Royal Berkshire NHS Foundation Trust
Reading, RG1 5AN
The Royal Wolverhampton NHS Trust
Wolverhampton, WV10 0QP
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Self-Monitoring of Blood Pressure
- Medical subject headings
- Pre-Eclampsia, Hypertension, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Monitoring of Blood PressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From study entry to delivery i.e. up to 40 weeks
Secondary outcomes (25)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At delivery
Early neonatal deaths
Difference between usual care and self-monitoring group in number of early neonatal deaths (BUMP 1 BUMP 2)
Measured: 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)
Measured: At delivery
Mode of delivery
Difference between usual care and self-monitoring group in mode of delivery (BUMP 1 and BUMP 2)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From study entry to 8 weeks postnatal i.e. up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start22 Nov 2017
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, High RiskStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 3,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Oxford University Hospitals NHS Trust, University of Southampton, University of Birmingham, Barts & The London NHS Trust, City, University of London, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Richard J McManus, PhD MBBS, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334149
- Sponsor's protocol ID
- 224978
- Acronym
- BUMP
- Status last verified
- Jan 2022
- First submitted
- 24 Oct 2017
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 31980512Tucker 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.
PubMed 35503346Chappell 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.
PubMed 35503345Campbell 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.
PubMed 38258566Hinton 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.
PubMed 33262186Ashworth 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.
PubMed 32748394
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
- ClinicalTrials.gov ID
- NCT03334149
- Acronym / sponsor ID
- BUMP / 224978
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,042 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- King's College London, Oxford University Hospitals NHS Trust, University of Southampton, University of Birmingham, Barts & The London NHS Trust, City, University of London, National Institute for Health Research, United Kingdom
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Self-Monitoring of Blood Pressure | Experimental | Other: Self-Monitoring of Blood PressureBUMP 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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:
Key exclusion criteria (3 listed)
- Chronic Hypertension
- Anticipated inpatient admission considered likely to lead to imminent delivery (within the next 48 hours)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Monitoring of Blood PressureBUMP 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. | Other | Self-Monitoring of Blood Pressure |
Primary outcome
Time from recruitment to diagnosis of raised blood pressure
Time frame: 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
Time frame: From study entry to delivery i.e. up to 40 weeks
Difference in mean systolic blood pressure between usual care and self-monitoring group.
25 secondary outcomes
Severe hypertension
Time frame: From study entry to delivery i.e. up to 40 weeks
Serious maternal complications
Time frame: From study entry to delivery i.e. up to 40 weeks
Onset of labour
Time frame: At delivery
Assessment of quality of life differences between arms
Time frame: 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
Time frame: From study entry to 8 weeks postpartum i.e. up to 48 weeks
Stillbirth
Time frame: At delivery
Early neonatal deaths
Time frame: From delivery up to 28 days postpartum i.e. up to 4 weeks
Gestation at delivery
Time frame: At delivery
Mode of delivery
Time frame: At delivery
Birth weight including centile
Time frame: At delivery
Small for gestational age infants
Time frame: At delivery
Neonatal unit admissions
Time frame: From delivery up to 28 days postpartum i.e. up to 4 weeks
Health behaviours
Time frame: 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
Time frame: From study entry to 8 weeks postnatal i.e. up to 48 weeks
Fidelity to monitoring schedule
Time frame: From study entry to delivery i.e. up to 48 weeks
STAI-6 short form anxiety questionnaire
Time frame: 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
Time frame: From study entry to 8 weeks postnatal i.e. up to 48 weeks
Health service costs
Time frame: From study entry to delivery i.e. up to 40 weeks
Cost per quality-adjusted life year gained over trial period
Time frame: From study entry to delivery i.e. up to 40 weeks
Qualitative
Time frame: From study entry to 8 weeks postpartum i.e. up to 48 weeks
Mean diastolic blood pressure
Time frame: From study entry to delivery i.e. up to 40 weeks
Mean area under the blood pressure over time curve
Time frame: From study entry to delivery i.e. up to 40 weeks
Mean proportion of readings above 140mmHg
Time frame: From study entry to delivery i.e. up to 40 weeks
Adherence to medication
Time frame: 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
Time frame: From study entry to 8 weeks postnatal i.e. up to 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Background: PubMed 31980512Dougall 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.
- Results publication: PubMed 35503346Tucker 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.
- Results publication: PubMed 35503345Chappell 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.
- Derived from this study: PubMed 38258566Campbell 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.
- Derived from this study: PubMed 33262186Hinton 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.
- Derived from this study: PubMed 32748394Ashworth 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J McManus, PhD MBBS principal investigator
University of Oxford
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Monitoring of Blood Pressure in people with Pregnancy, High Risk and Pre-Eclampsia, run by University of Oxford at 13 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from recruitment to diagnosis of raised blood pressure (time frame: From study entry to delivery i.e. up to approximately 25 weeks from recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03334149, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.