Hampton - Eligibility for Home Blood Pressure Monitoring
- Home Blood Pressure Monitoring (HBPM) allows a woman to self-monitor her blood pressure at home. Home readings may provide a more frequent or accurate picture of a woman’s BP than intermittent DAU or clinic readings. There is growing evidence for its role in pregnancy.
- Our experience so far shows a reduction in unnecessary DAU visits without incurring any adverse outcomes. Women report a positive experience.
- HBPM is not intended to replace necessary clinical reviews and monitoring of proteinuria, maternal blood tests or fetal wellbeing.
- We have developed a dynamic web-based application to make it easy for patients to record their results and for healthcare professionals to review their results. Women are able to enter blood pressures as long as they have access to a web browser. The application has been specifically designed to be as inclusive as possible.
HBPM requires excellent compliance from patients and vigilance from staff to make sure it is being used safely.
K2 Hampton can be offered to:
1. All pregnant women (including those who may need to self-isolate for a period)
2. Women determined as high-risk by NICE guidelines (or by the FMF first trimester screening)
3. Women with chronic hypertension, gestational hypertension, pre-eclampsia
Women determined as high-risk by NICE guidelines:
One of the following risk factors:
- Hypertensive disease during a previous pregnancy
- Chronic kidney disease
- Autoimmune disease (e.g. systemic lupus erythematosus or antiphospholipid syndrome)
- Type 1 or type 2 diabetes - first pregnancy
Two of the following risk factors:
- Age 40 years or older
- Pregnancy interval of more than 10 years
- Body mass index (BMI) of 35 kg/m2 or more family history of pre-eclampsia
- Multiple pregnancy
Eligibility for women with Hypertension in pregnancy
Staff working in DAU can offer HBPM to any woman who they think would benefit from it. The majority of these women will fulfil standard criteria for DAU referral and monitoring (gestational hypertension or borderline BP after 20 weeks gestation). Women with chronic hypertension who are booked for antenatal care with the maternal medicine team will have HBPM initiated through the hypertension clinic. Women who are seen in antenatal clinic with hypertension who do not fulfil DAU referral criteria (such as gestation less than 20 weeks) should be referred to your specialist team for the initiation of HBPM.
- Each team (DAU/Maternal Medicine) will be responsible for overseeing their own patients and ensuring appropriate follow-up plans are in place.
- Maternal medicine patients will be assessed by a member of the maternal medicine team regarding their suitability for HBPM whilst DAU patients should fit the criteria listed below.
- Any woman with mild-moderate hypertension in pregnancy
- Gestational Hypertension (GH)
- Chronic Hypertension
- White Coat Hypertension / ‘borderline BP profiles’.
- No significant proteinuria (see below)
- Women must have a good understanding of English (written and spoken) so that they can follow the instructions and give informed consent.
- No clinical indication for inpatient monitoring.
- Unable to give consent or understand the instructions.
- Declines HBPM
- Evidence of non-compliance with attendance or monitoring.
- Arm circumference greater than 42cm
- Delivery planned within 7 days
- Severe, uncontrolled hypertension that requires the woman to be admitted for stabilisation (HBPM can be started if she improves clinically and is appropriate for outpatient care).
- Any woman where there is concern over fetal growth/wellbeing.
- Woman with ≥ 2+ protein on dipstick or a positive PCR result (≥30).
There are currently two tests available on the market to test for pre-eclampsia. One which measures soluble fms-like kinase 1 (sFlt-1) and placenta; growth factor (PlGF) ratio to predict pre-eclampsia and one that measures just placental growth factor (PlGF). Either are valid test and we do no recommend one over the other. Below are the pathways that help determine whether women are eligible for HBPM or not.
sFlt/PlGF Ratio test
Women who have a confirmed diagnosis of Pre-eclampsia (PET) or who do not fulfil these criteria may have HBPM initiated as part of an individualised plan of care by a Consultant or senior obstetric trainee (ST6/7). These cases are not included in this pathway of HBPM in pregnancy.
K2 Hampton™ bears a UKCA to denote conformity with the provisions of Medical Device regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
- K2 Hampton™ is a Class I medical device
- K2 Hampton™ is identified by the Basic UDI number: 506047038HamptonG2
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If the User perceives a problem with the system, then this should be reported to a System Administrator or senior staff member, in the first instance. If an issue cannot be resolved internally and is directly attributed to K2 Hampton, then this should be escalated to the K2's Support Team, as per the Service Level Agreement.
An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device Users (including patients) or other persons as a result of a medical device failure or its misuse.
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TGA Website (Australia)
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National Competent Authority (EU)
National Competent Authority where adverse incident occurred.
Should an adverse incident occur, the K2 Support Team and the applicable regulatory authority MUST be contacted at the earliest opportunity.
Address of Manufacture
K2 Hampton™ is produced by K2 Medical Systems at the following address:
K2 Medical Systems Ltd
Derriford Business Park