Slow and Deep Breathing to Lower Blood Pressure in Women With Pregnancy-induced Hypertension

Study Overview
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Brief Summary
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This study evaluates the effect of slow and deep breathing on lowering blood pressure in women with pregnancy-induced hypertension. Slow and deep breathing will be practised daily for 10 minutes from enrolment until the woman gives birth. This feasibility study aims to investigate the practicality of conducting a proposed future randomised controlled trial.

Detailed Description
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In addition to the slow and deep breathing intervention the women will undertake a short protocol investigating the physiological responses to slow and deep breathing during their initial meeting. The women will undertake 4 separate 5-min breathing exercises with a 5 minute rest period between each exercise. The breathing exercises are normal breathing, and fixed breathing frequencies of 4, 6 and 8 breaths per minute. Blood pressure, heart rate and breathing rate will be monitored continuously, and non-invasively, throughout each breathing protocol. The women will also have the opportunity to provide feedback on the intervention and their experiences in an online survey at 36 weeks gestation.

Official Title
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Effects of Slow and Deep Breathing on Reducing Obstetric Intervention in Women With Pregnancy-induced Hypertension:A Feasibility Study

Conditions
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Pregnancy-Induced Hypertension

Intervention / Treatment
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* Other: Slow and deep breathing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with pregnancy-induced hypertension (PIH). Defined as new hypertension presenting after 20 weeks of pregnancy without significant proteinuria (urinary protein:creatinine ratio greater than 30mg/mmol by NICE guidelines (2010) OR diagnosed as having one-off high blood pressure but at risk of developing PIH; Single pregnancy; Capable of giving informed consent; Age over 18. Exclusion Criteria: Under 18 years old; Referred immediately to obstetric-care after PIH diagnosis for an immediate intervention, with systolic blood pressure over 160 mmHg or diastolic blood pressure over 100 mmHg; Multiple pregnancy (twins, triplets, etc.); Current smoker; Current diagnosis of respiratory diseases; asthma, COPD (Chronic Obstructive Pulmonary disease), bronchitis. (A previous occurrence or diagnosis that has not been present for longer than 1 year ago does not exclude participants, i.e. childhood asthma); Allergy/reaction to gel used on ECG tabs; Vulnerable participants who are unable to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will take part in the slow and deep breathing daily exercises.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow and deep breathing<br>Daily practice of slow and deep breathing for 10 minutes per day. Breathing frequency will be 6 breaths per minute, with participants accessing a video aid to help guide their breathing. Breathing exercises will be conducted from enrolment until birth (maximum  20 weeks if enrolment at 20 weeks gestation until  40 weeks gestation birth) | Other: Slow and deep breathing<br>* Please see arm description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the breathing exercise intervention | Proportion of days breathing exercise completed per participant and average proportion of days breathing exercise completed | Up to 22 weeks (From enrolment to giving birth) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women referred to obstetric-led care | Referral to obstetric-led care will be on the grounds of a test result of 30 mg/mmol^1 in a spot urinary protein, symptom exacerbation and/or increase in systolic and/or diastolic blood pressure | Up to 22 weeks (From enrolment to giving birth) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Slow and deep breathing, Feasibility study