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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334149
Recruitment Status : Active, not recruiting
First Posted : November 7, 2017
Last Update Posted : November 29, 2019
Sponsor:
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
Information provided by (Responsible Party):
University of Oxford

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : November 22, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Severe hypertension [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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 ]
    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 [ Time Frame: 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 [ Time Frame: At delivery ]
    Difference between usual care and self-monitoring group in number of stillbirths (BUMP 1 and BUMP 2)

  7. Early neonatal deaths [ Time Frame: 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 [ Time Frame: At delivery ]
    Difference between usual care and self-monitoring group in gestation at delivery (BUMP 1 and BUMP 2)

  9. Mode of delivery [ Time Frame: At delivery ]
    Difference between usual care and self-monitoring group in mode of delivery (BUMP 1 and BUMP 2)

  10. Birth weight including centile [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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. ]
    Difference between usual care and self-monitoring group in change in health behaviours (questionnaire) (BUMP 1 and BUMP 2)

  14. Health behaviours [ Time Frame: 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 [ Time Frame: 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 [ 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. ]
    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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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. ]
    Difference between usual care and self-monitoring group in change in adherence to medication (MARS) (BUMP 2)

  25. Adherence to medication [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant Women
Accepts Healthy Volunteers:   Yes
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334149


Locations
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United Kingdom
Buckinghamshire Healthcare NHS Trust
Aylesbury, United Kingdom, HP21 8AL
Birmingham Women's and Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom, B15 2TG
Croydon Health Services NHS Trust
London, United Kingdom, CR7 7YE
Barts Health NHS Trust
London, United Kingdom, E1 1BB
Kingston Hospital NHS Foundation Trust
London, United Kingdom, KT2 7QB
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 7EH
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom, SW10 9NH
St George's University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0QT
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX6 2GG
The Royal Berkshire NHS Foundation Trust
Reading, United Kingdom, RG1 5AN
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
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Principal Investigator: Richard J McManus, PhD MBBS University of Oxford
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03334149    
Other Study ID Numbers: 224978
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications