Physician Optimised Post-partum Hypertension Treatment (POP-HT) trial

SUMMARY:

This group has shown in a pilot randomised controlled study [SNAP-HT; REC 14/SC/1316] that blood pressure self-management during the post-partum period after hypertensive pregnancies, may result in lower blood pressure after six months; even when medication has been stopped.

We now want to assess whether this blood pressure reduction can be reproduced in a larger, randomised study [POP-HT; REC 19/LO/19901], and whether the blood pressure lowering has additional benefits in terms of other cardiovascular and cerebrovascular changes that are known to occur in women who have had a hypertensive pregnancy.

We therefore plan to run a trial of self-management in the post-partum period, using updated Blue-tooth® enabled blood pressure monitoring coupled to physician-assisted dose titration to further advance the self-management aspect of the intervention. The physicians will be specialist clinicians who form part of the research team. We will measure additional structural and functional end organ differences, using magnetic resonance imaging of the brain and heart as well as echocardiography and retinal imaging.

This will provide insight into the impact of post-partum blood pressure control on the maternal cardiovascular system and how this associates with blood pressure changes. Together, these studies will help refine future intervention strategies in this cohort of patients.

WHY THIS IS IMPORTANT:

High blood pressure disorders in pregnancy are associated with an increased risk of high blood pressure, heart attack and stroke in later life. The risks associated with high blood pressure in pregnancy can be mitigated by early recognition and treatment of raised blood pressure (and other traditional cardiovascular risk factors e.g. lack of regular exercise, eating an unhealthy diet).

This trial is looking at the impact that blood pressure control has on these long-term risks. We plan to assess whether blood pressure self-management can improve blood pressure control and whether this reduction in blood pressure in the months after birth can reduce the long-term effects these conditions have on your heart, brain and blood vessels, hopefully reducing the following risks associated with pre-eclampsia:

• 1 in 5 women having another hypertensive pregnancy
• 1 in 7 women having another pre-eclamptic pregnancy
• A 4x increase in risk of having long term high blood pressure
• A 2x increase in risk of experiencing both cardiovascular death or a heart attack
• A 1.5x increase in risk of having a stroke

(adapted from NICE NG 133: Hypertension in pregnancy July 2019)

SUMMARY OF THE METHODOLOGY:

High blood pressure occurs in ~1 in 10 women during pregnancy and remains elevated in 50% even after the baby is born requiring medication at home after discharge.

This study is investigating whether, ‘self- management’ of blood pressure (BP) at home, after discharge, can improve your blood pressure control and reduce the longer-term impact on your heart and brain.

50% of participants (the self-management group) will be asked to measure their blood pressure at home using a Wireless OMRON Evolv ® blood pressure monitor and upload the readings via a proprietary smart-phone/tablet app®.

If readings are abnormal then a specialist doctor can guide your medication adjustment accordingly (you will still have option of seeing your own GP/midwife if you prefer).

50% (the control group) will be looked after by their GP/ midwife/other NHS services as normal. The group you are in will be decided by random.

The study starts after giving birth and runs up-to 6-9 months after discharge from hospital and both the intervention and control group will have 4 study visits as part of the trial.

The team are aware that you will have a newborn baby/babies so study visits will be very flexible and can stop-start around feeding, nappy changes and other important baby needs.

N.B. All women will continue to receive routine NHS care throughout.

NEXT STEPS:

Recruitment will commence in February 2020, initially in Oxford at the John Radcliffe Hospital, with plans to expand to other sites over the coming months.