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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
3,042
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.
Buckinghamshire Healthcare NHS Trust
Aylesbury, United Kingdom
Birmingham Women's and Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom
Croydon Health Services NHS Trust
London, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Kingston Hospital NHS Foundation 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
Chelsea and Westminster 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
...and 3 more locations
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.
Time frame: 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.
Time frame: From study entry to delivery i.e. up to 40 weeks
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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
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)
Time frame: 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)
Time frame: At delivery
Early neonatal deaths
Difference between usual care and self-monitoring group in number of early neonatal deaths (BUMP 1 BUMP 2)
Time frame: 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)
Time frame: At delivery
Mode of delivery
Difference between usual care and self-monitoring group in mode of delivery (BUMP 1 and BUMP 2)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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
Difference between usual care and self-monitoring group in change in health behaviours (questionnaire) (BUMP 1 and BUMP 2)
Time frame: 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)
Time frame: 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)
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
Difference between usual care and self-monitoring group in change in STAI-6 short form anxiety questionnaire (BUMP 1 and BUMP 2)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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
Difference between usual care and self-monitoring group in change in adherence to medication (MARS) (BUMP 2)
Time frame: From study entry to 8 weeks postnatal i.e. up to 48 weeks
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