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

• Sponsor: University of Oxford (Other)
• Overall Status: Completed
• CT.gov ID: NCT03334149
• Collaborator: 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)
• Enrollment: 3,042
• Locations: 13
• Arms: 2
• Actual Duration (Months): 33.8
• Patients Per Site: 234
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, High Risk; Pre-Eclampsia; Hypertension; Hypertension, Pregnancy-Induced	Other: Self-Monitoring of Blood Pressure	N/A

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

• Study Type: Interventional
• Actual Enrollment: 3042 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Health Services Research
• Official Title: Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
• Actual Study Start Date: Nov 22, 2017
• Actual Primary Completion Date: Sep 16, 2020
• Actual Study Completion Date: Sep 16, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Time from recruitment to diagnosis of raised blood pressure [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.

2. Mean systolic blood pressure [From study entry to delivery i.e. up to 40 weeks]

   Difference in mean systolic blood pressure between usual care and self-monitoring group.

Secondary Outcome Measures

1. Severe hypertension [From study entry to delivery i.e. up to 40 weeks]

   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)

2. Serious maternal complications [From study entry to delivery i.e. up to 40 weeks]

   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)

3. Onset of labour [At delivery]

   Difference between usual care and self-monitoring group in onset of labour (BUMP 1 and BUMP 2)

4. 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]

   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)

5. Assessment of quality of life differences between arms [From study entry to 8 weeks postpartum i.e. up to 48 weeks]

   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)

6. Stillbirth [At delivery]

   Difference between usual care and self-monitoring group in number of stillbirths (BUMP 1 and BUMP 2)

7. Early neonatal deaths [From delivery up to 28 days postpartum i.e. up to 4 weeks]

   Difference between usual care and self-monitoring group in number of early neonatal deaths (BUMP 1 BUMP 2)

8. Gestation at delivery [At delivery]

   Difference between usual care and self-monitoring group in gestation at delivery (BUMP 1 and BUMP 2)

9. Mode of delivery [At delivery]

   Difference between usual care and self-monitoring group in mode of delivery (BUMP 1 and BUMP 2)

10. Birth weight including centile [At delivery]

    Difference between usual care and self-monitoring group in birth weight of the baby including centile (BUMP 1 and BUMP 2)

11. Small for gestational age infants [At delivery]

    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)

12. Neonatal unit admissions [From delivery up to 28 days postpartum i.e. up to 4 weeks]

    Difference between usual care and self-monitoring group in number of neonatal unit admissions including length of stay (BUMP 1 and BUMP 2)

13. Health behaviours [From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy.]

    Difference between usual care and self-monitoring group in change in health behaviours (questionnaire) (BUMP 1 and BUMP 2)

14. Health behaviours [From study entry to 8 weeks postnatal i.e. up to 48 weeks]

    Difference between usual care and self-monitoring group in change in health behaviours (questionnaire) (BUMP 1 and BUMP 2)

15. Fidelity to monitoring schedule [From study entry to delivery i.e. up to 48 weeks]

    Difference between usual care and self-monitoring group in fidelity to monitoring schedule (BUMP 1 and BUMP 2)

16. STAI-6 short form anxiety questionnaire [From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy.]

    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)

17. STAI-6 short form anxiety questionnaire [From study entry to 8 weeks postnatal i.e. up to 48 weeks]

    Difference between usual care and self-monitoring group in change in STAI-6 short form anxiety questionnaire (BUMP 1 and BUMP 2)

18. Health service costs [From study entry to delivery i.e. up to 40 weeks]

    Difference between usual care and self-monitoring group in health service costs. (BUMP 1 and BUMP 2)

19. Cost per quality-adjusted life year gained over trial period [From study entry to delivery i.e. up to 40 weeks]

    Difference between usual care and self-monitoring group in cost per quality-adjusted life year gained over trial period (BUMP 1 and BUMP 2)

20. Qualitative [From study entry to 8 weeks postpartum i.e. up to 48 weeks]

    Qualitative data gathered from participating women and healthcare professionals (BUMP 1 and BUMP 2)

21. Mean diastolic blood pressure [From study entry to delivery i.e. up to 40 weeks]

    Difference between usual care and self-monitoring group in mean diastolic blood pressure (BUMP 2)

22. Mean area under the blood pressure over time curve [From study entry to delivery i.e. up to 40 weeks]

    Difference between usual care and self-monitoring group in mean area under the blood pressure curve (BUMP 2)

23. Mean proportion of readings above 140mmHg [From study entry to delivery i.e. up to 40 weeks]

    Difference between usual care and self-monitoring group in mean proportion of readings above 140mmHg (BUMP 2)

24. Adherence to medication [From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy.]

    Difference between usual care and self-monitoring group in change in adherence to medication (MARS) (BUMP 2)

25. Adherence to medication [From study entry to 8 weeks postnatal i.e. up to 48 weeks]

    Difference between usual care and self-monitoring group in change in adherence to medication (MARS) (BUMP 2)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

• University of Oxford
• 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

Investigators

• Principal Investigator: Richard J McManus, PhD MBBS, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT03334149
• Other Study ID Numbers: 224978
• First Posted: Nov 7, 2017
• Last Update Posted: Jun 6, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Hypertension

Study Results

No Results Posted as of Jun 6, 2022