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

Not Applicable
Suspended
Conditions
Pregnancy-Induced Hypertension
Interventions
Other: Slow and deep breathing
Registration Number
NCT04059822
Lead Sponsor
Bournemouth University
Brief Summary

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

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.

Recruitment & Eligibility

Status
SUSPENDED
Sex
Female
Target Recruitment
67
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Slow and deep breathingSlow and deep breathingDaily 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)
Primary Outcome Measures
NameTimeMethod
Adherence to the breathing exercise interventionUp to 22 weeks (From enrolment to giving birth)

Proportion of days breathing exercise completed per participant and average proportion of days breathing exercise completed

Secondary Outcome Measures
NameTimeMethod
Proportion of women referred to obstetric-led careUp to 22 weeks (From enrolment to giving birth)

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

Trial Locations

Locations (2)

University Hospitals Dorset NHS Foundation Trust

🇬🇧

Poole, United Kingdom

Bournemouth University

🇬🇧

Bournemouth, United Kingdom

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