Clinical trial NCT03334149: Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
Official title: Blood Pressure Monitoring in High Risk Pregnancy to Improve the Detection and Monitoring of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, High Risk
Pre-Eclampsia
Hypertension
Hypertension, Pregnancy-Induced
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: King's College London
name: Oxford University Hospitals NHS Trust
name: University of Southampton
name: University of Birmingham
name: Barts & The London NHS Trust
name: City, University of London
name: National Institute for Health Research, United Kingdom
First posted: 2017-11-07
Enrollment: 3042
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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)

Primary outcomes:
measure: Time from recruitment to diagnosis of raised blood pressure
timeFrame: From study entry to delivery i.e. up to approximately 25 weeks from recruitment
measure: Mean systolic blood pressure
timeFrame: From study entry to delivery i.e. up to 40 weeks
Secondary outcomes:
measure: Severe hypertension
timeFrame: From study entry to delivery i.e. up to 40 weeks
measure: Serious maternal complications
timeFrame: From study entry to delivery i.e. up to 40 weeks
measure: Onset of labour
timeFrame: At delivery
measure: Assessment of quality of life differences between arms
timeFrame: From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy
measure: Assessment of quality of life differences between arms
timeFrame: From study entry to 8 weeks postpartum i.e. up to 48 weeks
measure: Stillbirth
timeFrame: At delivery
measure: Early neonatal deaths
timeFrame: From delivery up to 28 days postpartum i.e. up to 4 weeks
measure: Gestation at delivery
timeFrame: At delivery
measure: Mode of delivery
timeFrame: At delivery
measure: Birth weight including centile
timeFrame: At delivery
measure: Small for gestational age infants
timeFrame: At delivery
measure: Neonatal unit admissions
timeFrame: From delivery up to 28 days postpartum i.e. up to 4 weeks
measure: Health behaviours
timeFrame: From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy.
measure: Health behaviours
timeFrame: From study entry to 8 weeks postnatal i.e. up to 48 weeks
measure: Fidelity to monitoring schedule
timeFrame: From study entry to delivery i.e. up to 48 weeks
measure: STAI-6 short form anxiety questionnaire
timeFrame: From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy.
measure: STAI-6 short form anxiety questionnaire
timeFrame: From study entry to 8 weeks postnatal i.e. up to 48 weeks
measure: Health service costs
timeFrame: From study entry to delivery i.e. up to 40 weeks
measure: Cost per quality-adjusted life year gained over trial period
timeFrame: From study entry to delivery i.e. up to 40 weeks
measure: Qualitative
timeFrame: From study entry to 8 weeks postpartum i.e. up to 48 weeks
measure: Mean diastolic blood pressure
timeFrame: From study entry to delivery i.e. up to 40 weeks
measure: Mean area under the blood pressure over time curve
timeFrame: From study entry to delivery i.e. up to 40 weeks
measure: Mean proportion of readings above 140mmHg
timeFrame: From study entry to delivery i.e. up to 40 weeks
measure: Adherence to medication
timeFrame: From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy.
measure: Adherence to medication
timeFrame: From study entry to 8 weeks postnatal i.e. up to 48 weeks
Other outcomes:
Locations:
city: Aylesbury
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust
city: Birmingham
country: United Kingdom
facility: Birmingham Women's and Children's Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Croydon Health Services NHS Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Kingston Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Reading
country: United Kingdom
facility: The Royal Berkshire NHS Foundation Trust
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
Study officials:
affiliation: University of Oxford
name: Richard J McManus, PhD MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dougall G, Franssen M, Tucker KL, Yu LM, Hinton L, Rivero-Arias O, Abel L, Allen J, Band RJ, Chisholm A, Crawford C, Green M, Greenfield S, Hodgkinson J, Leeson P, McCourt C, MacKillop L, Nickless A, Sandall J, Santos M, Tarassenko L, Velardo C, Wilson H, Yardley L, Chappell L, McManus RJ. Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials. BMJ Open. 2020 Jan 23;10(1):e034593. doi: 10.1136/bmjopen-2019-034593.
citation: Tucker KL, Mort S, Yu LM, Campbell H, Rivero-Arias O, Wilson HM, Allen J, Band R, Chisholm A, Crawford C, Dougall G, Engonidou L, Franssen M, Green M, Greenfield S, Hinton L, Hodgkinson J, Lavallee L, Leeson P, McCourt C, Mackillop L, Sandall J, Santos M, Tarassenko L, Velardo C, Yardley L, Chappell LC, McManus RJ; BUMP Investigators. Effect of Self-monitoring of Blood Pressure on Diagnosis of Hypertension During Higher-Risk Pregnancy: The BUMP 1 Randomized Clinical Trial. JAMA. 2022 May 3;327(17):1656-1665. doi: 10.1001/jama.2022.4712.
citation: Chappell LC, Tucker KL, Galal U, Yu LM, Campbell H, Rivero-Arias O, Allen J, Band R, Chisholm A, Crawford C, Dougall G, Engonidou L, Franssen M, Green M, Greenfield S, Hinton L, Hodgkinson J, Lavallee L, Leeson P, McCourt C, Mackillop L, Sandall J, Santos M, Tarassenko L, Velardo C, Wilson H, Yardley L, McManus RJ; BUMP 2 Investigators. Effect of Self-monitoring of Blood Pressure on Blood Pressure Control in Pregnant Individuals With Chronic or Gestational Hypertension: The BUMP 2 Randomized Clinical Trial. JAMA. 2022 May 3;327(17):1666-1678. doi: 10.1001/jama.2022.4726.
citation: Hinton L, Hodgkinson J, Tucker KL, Rozmovits L, Chappell L, Greenfield S, McCourt C, Sandall J, McManus RJ. Exploring the potential for introducing home monitoring of blood pressure during pregnancy into maternity care: current views and experiences of staff-a qualitative study. BMJ Open. 2020 Dec 1;10(12):e037874. doi: 10.1136/bmjopen-2020-037874.
citation: Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.