Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04059822
Recruitment Status : Not yet recruiting
First Posted : August 16, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Bournemouth University

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.

Condition or disease Intervention/treatment Phase
Pregnancy-Induced Hypertension Other: Slow and deep breathing Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 67 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will take part in the slow and deep breathing daily exercises.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Slow and Deep Breathing on Reducing Obstetric Intervention in Women With Pregnancy-induced Hypertension:A Feasibility Study
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Please see arm description




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Proportion of women referred to obstetric-led care [ Time Frame: Up to 22 weeks (From enrolment to giving birth) ]
    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


Other Outcome Measures:
  1. Proportion of women eligible to participate in study [ Time Frame: 5 months (From start to end of recruitment period) ]
    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

  2. Recruitment rates of participation using a hospital antenatal unit [ Time Frame: 5 months (From start to end of recruitment period) ]
    Proportion of women participating in the study against number of eligible women who attend the antenatal unit

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

  4. Adherence to self-monitoring of daily blood pressure [ Time Frame: Up to 22 weeks (From enrolment to giving birth) ]
    Proportion of days blood pressure recorded per participant and average proportion of days blood pressure recorded

  5. Proportion of women withdrawing [ Time Frame: Up to 22 weeks (From enrolment to giving birth) ]
    Proportion of women who do not contribute data due to premature delivery, drop-out or worsening high blood pressure

  6. Difference in blood pressure [ Time Frame: Up to 22 weeks (From enrolment to giving birth) ]
    Average week 1 blood pressure compared with average last week blood pressure (last week prior to giving birth)

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

  8. Heart rate responses to slow and deep breathing [ Time Frame: Day 1 ]
    Differences in heart rate between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing)

  9. Blood pressure responses to slow and deep breathing [ Time Frame: Day 1 ]
    Differences in blood pressure between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing)

  10. Stroke volume responses to slow and deep breathing [ Time Frame: Day 1 ]
    Differences in stroke volume between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing)

  11. Cardiac output responses to slow and deep breathing [ Time Frame: Day 1 ]
    Differences in cardiac output between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;
  • First time pregnancy over 20 weeks gestation;
  • 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.);
  • Previous pregnancy. Defined as carrying a previous pregnancy until term or stillbirth;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04059822


Contacts
Layout table for location contacts
Contact: Malika Felton +441202 961845 mfelton@bournemouth.ac.uk
Contact: Suzy Wignall +441202 961073 swignall@bournemouth.ac.uk

Locations
Layout table for location information
United Kingdom
Bournemouth University Not yet recruiting
Bournemouth, Poole, United Kingdom, BH1 3LT
Contact: Malika Felton    +441202 961845      
Sponsors and Collaborators
Bournemouth University
Investigators
Layout table for investigator information
Principal Investigator: Malika Felton Postgraduate Researcher

Layout table for additonal information
Responsible Party: Bournemouth University
ClinicalTrials.gov Identifier: NCT04059822     History of Changes
Other Study ID Numbers: 251062
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bournemouth University:
Slow and deep breathing
Feasibility study
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Aspiration
Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Pregnancy Complications