Pregnancy-Induced Hypertension
Conditions
Keywords
Slow and deep breathing, Feasibility study
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.
Interventions
OTHERSlow and deep breathing
Please see arm description
Sponsors
Bournemouth University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will take part in the slow and deep breathing daily exercises.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the breathing exercise intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women referred to obstetric-led care | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women who would be willing to be randomised in future trials | 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 |
| Adherence to self-monitoring of daily blood pressure | 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 |
| Proportion of women withdrawing | 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 |
| Difference in blood pressure | 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) |
| Proportion of women eligible to participate in study | 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 |
| Heart rate responses to slow and deep breathing | Day 1 | Differences in heart rate between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing) |
| Blood pressure responses to slow and deep breathing | Day 1 | Differences in blood pressure between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing) |
| Stroke volume responses to slow and deep breathing | Day 1 | Differences in stroke volume between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing) |
| Cardiac output responses to slow and deep breathing | Day 1 | Differences in cardiac output between breathing protocols (5 minutes of breathing at 4, 6, and 8 breaths per minute and normal breathing) |
| Practicality of protocol in delivering slow and deep breathing as an intervention to treat high blood pressure during pregnancy. | 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. |
| Recruitment rates of participation using a hospital antenatal unit | 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 |
Countries
United Kingdom
Outcome results
None listed