NCT03334149

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,042 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-22
• Primary completion: 2020-09-16
• Completion: 2020-09-16
• First posted: 2017-11-07
• Last updated: 2022-06-06

Locations

13 sites across 1 country: United Kingdom