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

Not Applicable

Completed

• Conditions: Pre-Eclampsia; Hypertension; Pregnancy, High Risk; Hypertension, Pregnancy-Induced
• Interventions: Other: Self-Monitoring of Blood Pressure

• Registration Number: NCT03334149
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-07
• Study Start: 2017-11-22
• Primary Completion: 2020-09-16
• Study Completion: 2020-09-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3042

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)

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Monitoring of Blood Pressure	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.

Primary Outcome Measures

Name	Time	Method
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.
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

Name	Time	Method
Onset of labour	At delivery	Difference between usual care and self-monitoring group in onset of labour (BUMP 1 and BUMP 2)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Stillbirth	At delivery	Difference between usual care and self-monitoring group in number of stillbirths (BUMP 1 and BUMP 2)
Gestation at delivery	At delivery	Difference between usual care and self-monitoring group in gestation at delivery (BUMP 1 and BUMP 2)
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)
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)
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)
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)
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)
Mode of delivery	At delivery	Difference between usual care and self-monitoring group in mode of delivery (BUMP 1 and BUMP 2)
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)
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)

Trial Locations

Locations (13)

St George's University Hospitals NHS Foundation Trust; 🇬🇧 London, United Kingdom

Barts Health NHS Trust; 🇬🇧 London, United Kingdom

Oxford University Hospitals NHS Foundation Trust; 🇬🇧 Oxford, United Kingdom

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

Manchester University NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Kingston Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Chelsea and Westminster Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

The Royal Berkshire NHS Foundation Trust; 🇬🇧 Reading, United Kingdom

The Royal Wolverhampton NHS Trust; 🇬🇧 Wolverhampton, United Kingdom

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom