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

Bournemouth University

Status: Suspended

Conditions: Pregnancy-Induced Hypertension

Treatments: Other: Slow and deep breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT04059822

251062

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Slow and deep breathing

Experimental group

Description:

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)

Treatment:

Other: Slow and deep breathing