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

Primary Purpose

Pregnancy-Induced Hypertension

Status

Recruiting

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Slow and deep breathing

About this trial

This is an interventional treatment trial for Pregnancy-Induced Hypertension focused on measuring Slow and deep breathing, Feasibility study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Bournemouth UniversityRecruiting
University Hospitals Dorset NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Slow and deep breathing

Arm 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)

Outcomes

Primary Outcome Measures

Adherence to the breathing exercise intervention

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04059822

First Posted

August 13, 2019

Last Updated

January 3, 2023

Sponsor

Bournemouth University

1. Study Identification

Unique Protocol Identification Number

NCT04059822

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 14, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bournemouth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy-Induced Hypertension

Keywords

Slow and deep breathing, Feasibility study

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Slow and deep breathing

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Slow and deep breathing

Intervention Description

Please see arm description

Primary Outcome Measure Information:

Title

Adherence to the breathing exercise intervention

Description

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

Time Frame

Up to 22 weeks (From enrolment to giving birth)

Secondary Outcome Measure Information:

Title

Proportion of women referred to obstetric-led care

Description

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

Time Frame

Up to 22 weeks (From enrolment to giving birth)

Other Pre-specified Outcome Measures:

Title

Proportion of women eligible to participate in study

Description

Proportion of women eligible to participate in the study (using inclusion and exclusion criteria) against number of women who attend the antenatal unit for high blood pressure

Time Frame

5 months (From start to end of recruitment period)

Title

Recruitment rates of participation using a hospital antenatal unit

Description

Proportion of women participating in the study against number of eligible women who attend the antenatal unit

Time Frame

5 months (From start to end of recruitment period)

Title

Proportion of women who would be willing to be randomised in future trials

Description

Proportion of women who would be willing to be randomised in a future trial (asked in post-questionnaire) against those who would not be willing to be randomised

Time Frame

Between gestational age 36 weeks and birth. If participant gives birth prior to 36 weeks they will be invited to participate in the questionnaire when appropriate, but before 36 weeks

Title

Adherence to self-monitoring of daily blood pressure

Description

Proportion of days blood pressure recorded per participant and average proportion of days blood pressure recorded

Time Frame

Up to 22 weeks (From enrolment to giving birth)

Title

Proportion of women withdrawing

Description

Proportion of women who do not contribute data due to premature delivery, drop-out or worsening high blood pressure

Time Frame

Up to 22 weeks (From enrolment to giving birth)

Title

Difference in blood pressure

Description

Average week 1 blood pressure compared with average last week blood pressure (last week prior to giving birth)

Time Frame

Up to 22 weeks (From enrolment to giving birth)

Title

Practicality of protocol in delivering slow and deep breathing as an intervention to treat high blood pressure during pregnancy.

Description

Women's perceptions of the intervention, as assessed using the post-questionnaire. The questionnaire includes open ended questions on experiences and barriers to completing the intervention. Likert scale (strongly agree, agree, uncertain, disagree, strongly disagree) questions are also included.

Time Frame

Between gestational age 36 weeks and birth. If participant gives birth prior to 36 weeks they will be invited to participate in the questionnaire when appropriate, but before 36 weeks

Title

Heart rate responses to slow and deep breathing

Description

Differences in heart rate between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing)

Time Frame

Day 1

Title

Blood pressure responses to slow and deep breathing

Description

Differences in blood pressure between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing)

Time Frame

Day 1

Title

Stroke volume responses to slow and deep breathing

Description

Differences in stroke volume between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing)

Time Frame

Day 1

Title

Cardiac output responses to slow and deep breathing

Description

Differences in cardiac output between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing)

Time Frame

Day 1

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Malika Felton

Phone

+441202 961845

mfelton@bournemouth.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Suzy Wignall

Phone

+441202 961073

swignall@bournemouth.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Malika Felton

Organizational Affiliation

Postgraduate Researcher

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bournemouth University

City

Bournemouth

ZIP/Postal Code

BH8 8GP

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Malika Felton

mfelton@bournemouth.ac.uk

Facility Name

University Hospitals Dorset NHS Foundation Trust

City

Poole

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephanie Grigsby

Stephanie.Grigsby@uhd.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33463384

Citation

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.

Results Reference

derived

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

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