Active not recruitingNAINTERVENTIONAL

Physician Optimised Post-partum Hypertension Treatment Trial

This research explores a new way for women to manage high blood pressure after giving birth, specifically after conditions like pre-eclampsia or gestational hypertension. Participants will use a special Bluetooth blood pressure monitor and a smartphone app. Doctors will support them remotely to adjust medication if needed. The study compares this approach to standard care provided by GPs and midwives. Researchers want to see if this self-management helps keep blood pressure lower in the long term, potentially benefiting heart and brain health. This is a larger study building on earlier promising results, aiming to improve future care for mums after pregnancy-related high blood pressure.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Oxford

Enrolment target

200

Start

21 Feb 2020

Estimated completion

01 Dec 2030

Pre-Eclampsia Gestational Hypertension

What is this study about?

When you have high blood pressure during pregnancy (like pre-eclampsia or gestational hypertension), it's important to manage it well, even after the baby is born. This study explores a new, technology-assisted way for mums to look after their blood pressure at home in the months following birth. Researchers have seen in an earlier small study that women who managed their blood pressure themselves after a high-blood-pressure pregnancy had lower blood pressure six months later, even if they had stopped taking medication. This new, larger study aims to confirm if this approach truly works for more women.

The study will involve you using a special blood pressure monitor that connects to a smartphone app. This app helps you track your readings, and specialist doctors will oversee your progress remotely. They can help you adjust your medication if needed, ensuring your blood pressure stays at a healthy level. This is being compared to the usual care you would receive from your GP, midwife, or health visitor. The main goal is to see if this new self-management method helps keep your blood pressure down for longer.

Beyond just blood pressure, the researchers will also be looking at how this self-management affects your long-term health. They will use special scans of your brain and heart to see if keeping your blood pressure stable helps protect these organs. This detailed look will help doctors understand more about how high blood pressure in pregnancy can affect your body and how best to support mums in the future.

Key takeaways

Exploring a new way to manage blood pressure after pregnancy.
Uses a special blood pressure monitor and smartphone app.
Doctors will support your medication remotely if needed.
Compares this new approach to standard NHS care.
Aims to improve long-term heart and brain health for mums.
Study lasts for 6-9 months and includes some hospital visits for scans.

Who may be eligible?

This study is looking for women aged 18 or over. You might be suitable if you've recently had a baby and were diagnosed with high blood pressure during your pregnancy, such as gestational hypertension or pre-eclampsia. It's important that you still need medication to control your blood pressure when you're ready to leave the hospital after giving birth.

To take part, you'll need to be able to give your agreement to participate, have access to a smartphone or tablet, and be willing to use the study app if you're placed in that group. You also need to be able to understand instructions in English. The study is run from the John Radcliffe Hospital in Oxford, and you'd need to be recruited from there after giving birth.

Unfortunately, you wouldn't be able to join if you have very serious kidney or liver problems, if you're already scheduled for surgery (other than a C-section) during the study period, or if you have certain other serious health conditions. Women with high blood pressure that started before their pregnancy are also not included in this study.

Quick self-check

Are you 18 years old or older?
Did you have high blood pressure (gestational hypertension or pre-eclampsia) during your recent pregnancy?
Do you still need medication for high blood pressure when you leave the hospital after birth?
Do you have a smartphone or tablet and are you happy to use an app?
Can you understand and follow instructions in English?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be assigned by chance to one of two groups. One group will continue with their usual care from their GP and midwife. The other group will use a special Bluetooth blood pressure monitor at home and a smartphone app. Doctors will monitor your blood pressure remotely and help adjust your medication as needed. You'll also have some periods of 24-hour home blood pressure monitoring.

The study will involve several visits for assessments, including special scans of your brain and heart using MRI, as well as heart scans (echocardiography) and eye scans (retinal imaging). These assessments help the researchers understand the impact of blood pressure control on your body. The study will last for 6 to 9 months after your baby is born. The research team will guide you through each step and ensure you understand what's involved.

Potential risks and benefits

By taking part, you might benefit from closer monitoring of your blood pressure and potentially a new, more effective way to manage it after pregnancy, which could lead to better long-term health. However, as with any study, there are no guarantees of benefit, and some people may find the extra monitoring or app use inconvenient. There are also very small risks associated with the MRI scans, though these are carefully considered. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (2)

Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford
Oxford, United Kingdom

Common questions

What is gestational hypertension or pre-eclampsia?

These are types of high blood pressure that can develop during pregnancy. Pre-eclampsia also involves signs of organ damage, often to the kidneys.

Do I need to live in Oxford to take part?

Yes, you would need to be recruited from the Oxford Women's Centre at the John Radcliffe Hospital to participate.

Will the study tell me how to stop my blood pressure medication?

No, the study will involve doctors overseeing your medication adjustments. They will work with you to ensure your blood pressure is safely managed, which might include adjusting or stopping medication if appropriate for your health.

What is an MRI scan?

An MRI (Magnetic Resonance Imaging) is a type of scan that uses strong magnets and radio waves to create detailed pictures of organs and tissues inside your body, like your brain and heart.

Will I know which group I am in?

No, for research accuracy, you will not know whether you are in the 'usual care' group or the 'self-management' group. This helps ensure the results are unbiased.