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

University of Oxford

Status: Completed

Conditions: Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy, High Risk

Treatments: Other: Self-Monitoring of Blood Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03334149

224978

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,042 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,042 participants in 2 patient groups

Self-Monitoring of Blood Pressure

Experimental group

Description:

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.

Treatment:

Other: Self-Monitoring of Blood Pressure

Usual Care

No Intervention group

Description:

Women randomised to usual care will continue to have all their BP monitoring completed by the clinical team at their antenatal assessments.