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

NCT ID: NCT04059822

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2023-04-28

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.

Conditions

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Pregnancy-Induced Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will take part in the slow and deep breathing daily exercises.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Slow and deep breathing

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)

Group Type EXPERIMENTAL

Slow and deep breathing

Intervention Type OTHER

Please see arm description

Interventions

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Slow and deep breathing

Please see arm description

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bournemouth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malika Felton

Role: PRINCIPAL_INVESTIGATOR

Postgraduate Researcher

Locations

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Bournemouth University

Bournemouth, , United Kingdom

Site Status

University Hospitals Dorset NHS Foundation Trust

Poole, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Felton M, Hundley VA, Grigsby S, McConnell AK. Effects of slow and deep breathing on reducing obstetric intervention in women with pregnancy-induced hypertension: a feasibility study protocol. Hypertens Pregnancy. 2021 Feb;40(1):81-87. doi: 10.1080/10641955.2020.1869250. Epub 2021 Jan 19.

Reference Type DERIVED
PMID: 33463384 (View on PubMed)

Other Identifiers

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251062

Identifier Type: -

Identifier Source: org_study_id

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