Pregnancy-Induced HypertensionNCT04059822
Slow and Deep Breathing to Lower Blood Pressure in Women With Pregnancy-induced Hypertension
A study testing Slow and deep breathing in people with Pregnancy-Induced Hypertension, run by Bournemouth University at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy-Induced Hypertension
- What is being tested?
- Slow and deep breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 14 Jan 2020to 28 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Bournemouth University
Bournemouth, BH8 8GP
University Hospitals Dorset NHS Foundation Trust
Poole
About this study
Official title: Effects of Slow and Deep Breathing on Reducing Obstetric Intervention in Women With Pregnancy-induced Hypertension:A Feasibility Study
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.
- Conditions
- Pregnancy-Induced Hypertension
- Being tested
- Slow and deep breathing
- Keywords
- Slow and deep breathing, Feasibility study
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow and deep breathingOther
Please see arm description
| Study group | Role | What they receive |
|---|---|---|
| Slow and deep breathing | Experimental | 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) Receives: Other: Slow and deep breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the breathing exercise intervention
Proportion of days breathing exercise completed per participant and average proportion of days breathing exercise completed
Measured: 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
Measured: Up to 22 weeks (From enrolment to giving birth)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start14 Jan 2020
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Why it stopped: Funding and recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy-Induced HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will take part in the slow and deep breathing daily exercises.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malika Felton, Principal investigator, Postgraduate Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059822
- Sponsor's protocol ID
- 251062
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2019
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Slow and Deep Breathing on Reducing Obstetric Intervention in Women With Pregnancy-induced Hypertension:A Feasibility Study
- ClinicalTrials.gov ID
- NCT04059822
- Acronym / sponsor ID
- 251062
- Conditions
- Pregnancy-Induced Hypertension
- Keywords
- Slow and deep breathing, Feasibility study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding and recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will take part in the slow and deep breathing daily exercises.
| Arm | Type | Receives |
|---|---|---|
| Slow and deep breathing | Experimental | Other: Slow 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow and deep breathingPlease see arm description | Other | Slow and deep breathing |
Primary outcome
Adherence to the breathing exercise intervention
Time frame: Up to 22 weeks (From enrolment to giving birth)
Proportion of days breathing exercise completed per participant and average proportion of days breathing exercise completed
1 secondary outcome
Proportion of women referred to obstetric-led care
Time frame: Up to 22 weeks (From enrolment to giving birth)
Results and safety
The study was stopped early (reason given: Funding and recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Derived from this study: PubMed 33463384Felton 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.
- Individual participant dataSharing planned: No
Related trials for Pregnancy-Induced Hypertension
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
RecruitingPhase 3
Preeclampsia Intervention Netherlands
Pre-Eclampsia Onset Less Than 37 Weeks, Pre-Eclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malika Felton principal investigator
Postgraduate Researcher
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow and deep breathing in people with Pregnancy-Induced Hypertension, run by Bournemouth University at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding and recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the breathing exercise intervention (time frame: Up to 22 weeks (From enrolment to giving birth)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04059822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.