An interventional study of Self-Monitoring of Blood Pressure in Pregnancy, High Risk, Pre-Eclampsia and Hypertension, sponsored by University of Oxford. Completed at 13 sites in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-06.
Sponsored by University of Oxford · Not applicable, Interventional, and Health services research
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Among 11 studies in Pre-Eclampsia by University of Oxford — 4 open to participants now, 5 under way, none of them phase 3. Pre-Eclampsia · University of Oxford.
Among the 11 studies in Pre-Eclampsia by University of Oxford, this one is the only one that started in 2017, is one of 6 with no phase, and was the 5th registered.
917 studies on the registry are indexed under Pre-Eclampsia; 244 are open to participants now.
Browse Pre-Eclampsia studies →4 of the 11 studies in Pre-Eclampsia by University of Oxford are open now, in 1 country. Recruiting first, the newest first:
University of Oxford · Sites in United Kingdom
Ages 16+ · Women only · Healthy volunteers
University of Oxford · Sites in United Kingdom
Ages 18+ · Women only · Healthy volunteers
University of Oxford · Sites in United Kingdom
Ages 30–70 · Women only
University of Oxford · Sites in United Kingdom
Ages 18–45 · Women only · Healthy volunteers
By country, each count listing its studies:
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3,042 is above the median of 110 across 481 interventional studies indexed under Pre-Eclampsia.
Median enrollment 200 across the 7 interventional studies, 330 across the 4 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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University of Oxford is the lead sponsor of 813 studies on the registry; 120 are open to participants now.
1 of the studies in Pre-Eclampsia by University of Oxford that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06187012University of OxfordHypertension Explored in Long-term Postpartum Follow-up in Later Life | 2027-11-01 |
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Among the 11 studies in Pre-Eclampsia by University of Oxford, from their registry updates:
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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:
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.
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.
BUMP 1
Inclusion Criteria:
Exclusion Criteria:
BUMP 2:
Inclusion Criteria:
OR
OR
AND
Exclusion criteria:
Anticipated inpatient admission considered likely to lead to imminent delivery (within the next 48 hours)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Self-Monitoring of Blood Pressure
Women randomised to usual care will continue to have all their BP monitoring completed by the clinical team at their antenatal assessments.
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.
Time from recruitment to diagnosis of raised blood pressure
Difference between groups in time from recruitment to recording of raised blood pressure by health care professional.
Time frame: From study entry to delivery i.e. up to approximately 25 weeks from recruitment
Mean systolic blood pressure
Difference in mean systolic blood pressure between usual care and self-monitoring group.
Time frame: From study entry to delivery i.e. up to 40 weeks
Severe hypertension
Difference between usual care and self-monitoring group in severe hypertension (systolic BP ≥160mmHg and/or or diastolic BP ≥110mmHg) (BUMP 1 and BUMP 2)
Time frame: From study entry to delivery i.e. up to 40 weeks
Serious maternal complications
Difference between usual care and self-monitoring group in serious maternal complications (pre-eclampsia, placental abruption, transient ischemic attack or stroke, pulmonary oedema, renal failure, blood transfusion), death (BUMP 1 and BUMP 2)
Time frame: From study entry to delivery i.e. up to 40 weeks
Onset of labour
Difference between usual care and self-monitoring group in onset of labour (BUMP 1 and BUMP 2)
Time frame: At delivery
Assessment of quality of life differences between arms
Difference between usual care and self-monitoring group in change in quality of life (measured using the EQ-5D-5L) (BUMP 1 and BUMP 2)
Time frame: From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy
Assessment of quality of life differences between arms
Difference between usual care and self-monitoring group in change in quality of life (measured using the EQ-5D-5L (BUMP 1 and BUMP 2)
Time frame: From study entry to 8 weeks postpartum i.e. up to 48 weeks
Stillbirth
Difference between usual care and self-monitoring group in number of stillbirths (BUMP 1 and BUMP 2)
Time frame: At delivery
Early neonatal deaths
Difference between usual care and self-monitoring group in number of early neonatal deaths (BUMP 1 BUMP 2)
Time frame: From delivery up to 28 days postpartum i.e. up to 4 weeks
Gestation at delivery
Difference between usual care and self-monitoring group in gestation at delivery (BUMP 1 and BUMP 2)
Time frame: At delivery
Mode of delivery
Difference between usual care and self-monitoring group in mode of delivery (BUMP 1 and BUMP 2)
Time frame: At delivery
Birth weight including centile
Difference between usual care and self-monitoring group in birth weight of the baby including centile (BUMP 1 and BUMP 2)
Time frame: At delivery
Small for gestational age infants
Difference between usual care and self-monitoring group in number of small for gestational age infants (\<10th and \<3rd centile) (BUMP 1 and BUMP 2)
Time frame: At delivery
Neonatal unit admissions
Difference between usual care and self-monitoring group in number of neonatal unit admissions including length of stay (BUMP 1 and BUMP 2)
Time frame: From delivery up to 28 days postpartum i.e. up to 4 weeks
Health behaviours
Difference between usual care and self-monitoring group in change in health behaviours (questionnaire) (BUMP 1 and BUMP 2)
Time frame: From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy.
Health behaviours
Difference between usual care and self-monitoring group in change in health behaviours (questionnaire) (BUMP 1 and BUMP 2)
Time frame: From study entry to 8 weeks postnatal i.e. up to 48 weeks
Fidelity to monitoring schedule
Difference between usual care and self-monitoring group in fidelity to monitoring schedule (BUMP 1 and BUMP 2)
Time frame: From study entry to delivery i.e. up to 48 weeks
STAI-6 short form anxiety questionnaire
Difference between usual care and self-monitoring group in change in State trait anxiety inventory short form anxiety questionnaire (STAI-6 ) (BUMP 1 and BUMP 2)
Time frame: From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy.
STAI-6 short form anxiety questionnaire
Difference between usual care and self-monitoring group in change in STAI-6 short form anxiety questionnaire (BUMP 1 and BUMP 2)
Time frame: From study entry to 8 weeks postnatal i.e. up to 48 weeks
Health service costs
Difference between usual care and self-monitoring group in health service costs. (BUMP 1 and BUMP 2)
Time frame: From study entry to delivery i.e. up to 40 weeks
Cost per quality-adjusted life year gained over trial period
Difference between usual care and self-monitoring group in cost per quality-adjusted life year gained over trial period (BUMP 1 and BUMP 2)
Time frame: From study entry to delivery i.e. up to 40 weeks
Qualitative
Qualitative data gathered from participating women and healthcare professionals (BUMP 1 and BUMP 2)
Time frame: From study entry to 8 weeks postpartum i.e. up to 48 weeks
Mean diastolic blood pressure
Difference between usual care and self-monitoring group in mean diastolic blood pressure (BUMP 2)
Time frame: From study entry to delivery i.e. up to 40 weeks
Mean area under the blood pressure over time curve
Difference between usual care and self-monitoring group in mean area under the blood pressure curve (BUMP 2)
Time frame: From study entry to delivery i.e. up to 40 weeks
Mean proportion of readings above 140mmHg
Difference between usual care and self-monitoring group in mean proportion of readings above 140mmHg (BUMP 2)
Time frame: From study entry to delivery i.e. up to 40 weeks
Adherence to medication
Difference between usual care and self-monitoring group in change in adherence to medication (MARS) (BUMP 2)
Time frame: From study entry to 30 weeks of pregnancy, or from study entry to 2 weeks following study entry if randomised after 30 weeks pregnancy.
Adherence to medication
Difference between usual care and self-monitoring group in change in adherence to medication (MARS) (BUMP 2)
Time frame: From study entry to 8 weeks postnatal i.e. up to 48 weeks
Plan to share: Yes — Data are available from the authors upon reasonable request and with permission of the University of Oxford. Use of data will require approval by an independent review committee identified for this purpose and investigators requesting data will need to provide a written protocol including analysis plan and sign a data sharing/access agreement. Requests for Data Sharing should be directed to information.guardian@phc.ox.ac.uk.
Supporting information: Study protocol, Statistical analysis plan
Time frame: from 31st May 2023
Access criteria: Use of data will require approval by an independent review committee identified for this purpose and investigators requesting data will need to provide a written protocol including analysis plan and sign a data sharing/access agreement.
Ran from Nov 2017 to primary completion in Sep 2020, 33 months.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's 33 months is above that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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