Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 2412
Summary
- Conditions
- Hypertension
- Hypertension Pregnancy-induced
- Pre Eclampsia
- Pregnancy, High Risk
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Note Women in BUMP 1 will transfer to BUMP 2 if they develop hypertension. Women in BUMP 2 can be randomised de novo or join from BUMP 1 maintaining their original randomisation. The enrolment number below therefore includes BUMP 1 (2262) plus BUMP 2 (512). Permission was granted by the ethics committee to continue recruitment passed the original sample size until the original planned end of recruitment date.Masking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 h...
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.
Tracking Information
- NCT #
- NCT03334149
- Collaborators
- King's College London
- Oxford University Hospitals NHS Trust
- University of Southampton
- University of Birmingham
- Barts & The London NHS Trust
- City, University of London
- National Institute for Health Research, United Kingdom
- Investigators
- Principal Investigator: Richard J McManus, PhD MBBS University of Oxford
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