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

Hypertension Clinical Trial

— BUMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03334149
• Other study ID #: 224978
• Status: Completed
• Phase: N/A
• Start date: November 22, 2017
• Est. completion date: September 16, 2020

Study information

• Verified date: January 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3042
• Est. completion date: September 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Buckinghamshire Healthcare NHS Trust	Aylesbury
United Kingdom	Birmingham Women's and Children's Hospital NHS Foundation Trust	Birmingham
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Chelsea and Westminster Hospital NHS Foundation Trust	London
United Kingdom	Croydon Health Services NHS Trust	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	Kingston Hospital NHS Foundation Trust	London
United Kingdom	St George's University Hospitals NHS Foundation Trust	London
United Kingdom	Manchester University NHS Foundation Trust	Manchester
United Kingdom	Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	The Royal Berkshire NHS Foundation Trust	Reading
United Kingdom	The Royal Wolverhampton NHS Trust	Wolverhampton

Sponsors (8)

Lead Sponsor	Collaborator
University of Oxford	Barts & The London NHS Trust, City, University of London, King's College London, National Institute for Health Research, United Kingdom, Oxford University Hospitals NHS Trust, University of Birmingham, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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 — View Citation

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. — View Citation

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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Onset of labour	Difference between usual care and self-monitoring group in onset of labour (BUMP 1 and BUMP 2)	At delivery
Secondary	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
Secondary	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
Secondary	Stillbirth	Difference between usual care and self-monitoring group in number of stillbirths (BUMP 1 and BUMP 2)	At delivery
Secondary	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
Secondary	Gestation at delivery	Difference between usual care and self-monitoring group in gestation at delivery (BUMP 1 and BUMP 2)	At delivery
Secondary	Mode of delivery	Difference between usual care and self-monitoring group in mode of delivery (BUMP 1 and BUMP 2)	At delivery
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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