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Pranayama for Hypertension in Pregnancy
N/A
Recruiting
Led By Shilpa Babbar, MD
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one visit, 15 minute intervention
Awards & highlights
Study Summary
This trial will test the effects of different deep breathing techniques on blood pressure during pregnancy.
Who is the study for?
This trial is for English-speaking pregnant women over 18 years old in their third trimester with high blood pressure, either gestational hypertension or chronic hypertension without severe features. It's not for those needing urgent delivery, with pre-eclampsia concerns, severe lung disease, deviated nasal septum, difficulty breathing through the nose, or very low blood pressure.Check my eligibility
What is being tested?
The study tests how Alternate Nostril Breathing, Bhramari Breathing, and Sheetali Breathing affect blood pressure during pregnancy. It also looks at other physiological parameters like heart rate and respiratory rate to see if these yogic techniques can naturally reduce them.See study design
What are the potential side effects?
Since this trial involves non-invasive breathing exercises from yoga practices rather than medication or surgery, side effects are minimal but may include discomfort due to breath control or dizziness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have high blood pressure during pregnancy without organ damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one visit, 15 minute intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one visit, 15 minute intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hypertensive disease
Secondary outcome measures
Change in body temperature from baseline to after the intervention
Change in cardiac output from baseline to after the intervention
Change of heart rate from baseline to after the intervention
Trial Design
6Treatment groups
Active Control
Group I: Sheetali Breathing Phase IActive Control1 Intervention
Sheetali breathing for normotensive women in 3rd trimester of pregnancy
Group II: Alternate Nostril Breathing Phase IIActive Control1 Intervention
Alternate nostril breathing for hypertensive women in 3rd trimester of pregnancy
Group III: Sheetali Breathing Phase IIActive Control1 Intervention
Sheetali breathing for hypertensive women in 3rd trimester of pregnancy
Group IV: Alternate Nostril Breathing Phase IActive Control1 Intervention
Alternate nostril breathing for normotensive women in 3rd trimester of pregnancy
Group V: Bhramari Breathing Phase IActive Control1 Intervention
Bhramari breathing for normotensive women in 3rd trimester of pregnancy
Group VI: Bhramari Breathing Phase IIActive Control1 Intervention
Bhramari breathing for hypertensive women in 3rd trimester of pregnancy
Find a Location
Who is running the clinical trial?
Children's Mercy Hospital Kansas CityLead Sponsor
245 Previous Clinical Trials
935,709 Total Patients Enrolled
Shilpa Babbar, MDPrincipal InvestigatorChildren's Mercy Hospital Kansas City
2 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have trouble breathing through my nose.I have a deviated septum.For Phase II only: You have had consistently high blood pressure before or during the early stages of pregnancy, and may or may not be taking medication for it.I have an ongoing or recent lung condition.Your blood pressure is too low, with a systolic reading of 90 mmHg or lower and/or a diastolic reading of 60 mmHg or lower.You are unable to roll your tongue.I am a pregnant woman in my third trimester, over 18, and speak English.I have high blood pressure during pregnancy without organ damage.I do not want to do breath-controlled exercises.I have preeclampsia without severe symptoms.I have a severe lung condition.You are at risk of developing pre-eclampsia during pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Sheetali Breathing Phase I
- Group 2: Alternate Nostril Breathing Phase II
- Group 3: Sheetali Breathing Phase II
- Group 4: Alternate Nostril Breathing Phase I
- Group 5: Bhramari Breathing Phase I
- Group 6: Bhramari Breathing Phase II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest number of volunteers participating in this research project?
"Affirmative. According to clinicaltrials.gov, this medical trial is currently recruiting participants and has been since August 2nd 2022; the study details were last amended on September 15th 2022. Approximately 90 patients must be enrolled from 1 site for the trial to commence."
Answered by AI
Are there any vacancies available to join this scientific experiment?
"Affirmative. Clinicaltrials.gov verifies that this clinical trial, listed since August 2nd 2022, is currently recruiting potential candidates. 90 individuals need to be enrolled from 1 centre in total."
Answered by AI
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