Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2022-08-02
2024-12-31
Brief Summary
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Detailed Description
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Upon presentation, they will be randomized into one of three groups: Alternate nostril breathing, Bhramari breathing or Sheetali breathing. Maternal monitoring devices will be placed on the patient before the intervention. The fetus will be monitored by external monitors consisting of a fetal heart rate monitor and tocodynamometer to assess uterine activity. Fetal position will be assessed before and after the intervention by ultrasound. All devices will obtain a reading for 15 minutes before, during and after the intervention.
Intervention: In an upright, seated position, the participant will engage in a total of 15 minutes of one deep breathing technique. The breathing practice will be conducted in three, 5-minute increments with a one-minute break between each session. These breathing techniques are easy to learn and participants will be taught how to perform the exercise (visual demonstration, verbal and written instructions will be provided). Participants will be given the opportunity to practice the breathing technique and ask any questions prior to initiating monitoring.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Alternate Nostril Breathing Phase I
Alternate nostril breathing for normotensive women in 3rd trimester of pregnancy
Alternate Nostril Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Bhramari Breathing Phase I
Bhramari breathing for normotensive women in 3rd trimester of pregnancy
Bhramari Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Sheetali Breathing Phase I
Sheetali breathing for normotensive women in 3rd trimester of pregnancy
Sheetali Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Alternate Nostril Breathing Phase II
Alternate nostril breathing for hypertensive women in 3rd trimester of pregnancy
Alternate Nostril Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Bhramari Breathing Phase II
Bhramari breathing for hypertensive women in 3rd trimester of pregnancy
Bhramari Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Sheetali Breathing Phase II
Sheetali breathing for hypertensive women in 3rd trimester of pregnancy
Sheetali Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Interventions
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Alternate Nostril Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Bhramari Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Sheetali Breathing
Utilizing Pranayama (deep breathing technique) in normotensive and hypertensive women in 3rd trimester of pregnancy
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* English speaking
* Phase II Only- Chronic hypertension - defined as pre-existing elevated blood pressure prior to pregnancy or less than 20 weeks gestation (Systolic blood pressure greater than or equal to 140 mmHg and /or a diastolic blood pressure greater than or equal to 90 mmHg) with or without antihypertensive use
* Phase II Only- Gestational hypertension - defined as elevated blood pressure (Systolic blood pressure greater than or equal to 140 mmHg and /or a diastolic blood pressure greater than or equal to 90 mmHg) after 20 weeks of pregnancy without any evidence of end-organ damage or proteinuria, with or without antihypertensive use
* Phase II Only- Preeclampsia without severe features - defined as elevated blood pressure (Systolic blood pressure greater than or equal to 140 mmHg but less than 160 mmHG and /or a diastolic blood pressure greater than or equal to 90 mmHg but less than 110 mmHg on two or more occasions 4 hours or more apart) with evidence of proteinuria, with or without antihypertensive use
Exclusion Criteria
* Any concerns for pre-eclampsia with or without severe features (i.e. Development of HELLP syndrome or eclampsia)
* Severe pulmonary disease
* Active or acute pulmonary disease
* Known deviated nasal septum
* Does not desire to perform breath-controlled exercises
* Low blood pressure defined as baseline blood pressure less or equal to a systolic of 90 mmHg and/or a diastolic blood pressure of 60 mmHg
* Cannot roll their tongue
* Have difficulty or cannot breathe through their nose
18 Years
FEMALE
Yes
Sponsors
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Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Principal Investigators
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Shilpa Babbar, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Locations
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Advent Health Shawnee Mission Birth Center
Merriam, Kansas, United States
Countries
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Other Identifiers
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STUDY00002180
Identifier Type: -
Identifier Source: org_study_id
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