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TerminatedNCT04059822Updated Sep 19, 2025

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

An interventional study of Slow and deep breathing in Pregnancy-Induced Hypertension, sponsored by Bournemouth University. Terminated at 2 sites in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Bournemouth University · Not applicable, Interventional, and Treatment

Why this study was terminated
Funding and recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Pregnancy-Induced Hypertension

Keywords

  • Slow and deep breathing
  • Feasibility study
03

In context

Hypertension, Pregnancy-Induced

240 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 66 are open to participants now.

This study's enrollment of 1 is below the median of 144 across 163 interventional studies indexed under Hypertension, Pregnancy-Induced.

Browse Hypertension, Pregnancy-Induced studies →

Lead sponsor

Bournemouth University is the lead sponsor of 52 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    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)

    Other: Slow and deep breathing

Interventions

  • OtherSlow and deep breathing

    Please see arm description

06

What researchers measure

Primary outcomes

  1. Adherence to the breathing exercise intervention

    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 outcomes

  1. 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

    Time frame: Up to 22 weeks (From enrolment to giving birth)

Other outcomes

  1. Proportion of women eligible to participate in study

    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)

  2. Recruitment rates of participation using a hospital antenatal unit

    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)

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

    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

  4. Adherence to self-monitoring of daily blood pressure

    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)

  5. Proportion of women withdrawing

    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)

  6. Difference in blood pressure

    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)

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

    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

  8. Heart rate responses to slow and deep breathing

    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

  9. Blood pressure responses to slow and deep breathing

    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

  10. Stroke volume responses to slow and deep breathing

    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

  11. Cardiac output responses to slow and deep breathing

    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

07

Study locations

2 sites
  • Bournemouth University
    Bournemouth, BH8 8GP, United Kingdom
  • University Hospitals Dorset NHS Foundation Trust
    Poole, United Kingdom
08

References and documents

Publications

  • 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. PubMed 33463384 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04059822
Lead sponsor
Bournemouth University
Responsible party
Sponsor
First posted
Aug 16, 2019
Start date
Jan 14, 2020
Primary completion
Apr 28, 2023
Completion
Apr 28, 2023
Last update
Sep 19, 2025

Study contacts

Malika Felton
principal investigator · Postgraduate Researcher

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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