Status:
COMPLETED
Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
King's College London
Oxford University Hospitals NHS Trust
Conditions:
Pregnancy, High Risk
Pre-Eclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
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 a...
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 hype...
Eligibility Criteria
Inclusion
- BUMP 1
- 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
- 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)
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2020
Estimated Enrollment :
3042 Patients enrolled
Trial Details
Trial ID
NCT03334149
Start Date
November 22 2017
End Date
September 16 2020
Last Update
June 6 2022
Active Locations (13)
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1
Buckinghamshire Healthcare NHS Trust
Aylesbury, United Kingdom, HP21 8AL
2
Birmingham Women's and Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom, B15 2TG
3
Croydon Health Services NHS Trust
London, United Kingdom, CR7 7YE
4
Barts Health NHS Trust
London, United Kingdom, E1 1BB