| CTRI Number |
CTRI/2011/10/002096 [Registered on: 31/10/2011] Trial Registered Retrospectively |
| Last Modified On: |
28/10/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The Effects of Yoga in Prevention of Pregnancy Complications in pregnant women who have high chance of developing them.
|
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Scientific Title of Study
|
The effect of yoga interventions in prevention of pregnancy complications in high risk pregnancies - A randomized controlled obstetric Doppler trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Nagarathna |
| Designation |
Dean, Life Sciences |
| Affiliation |
SVYASA University |
| Address |
Eknath Bhavan, # 19,
Gavipuram Circle, Kempegowda-Nagar
Bangalore
KARNATAKA
560 019
India |
| Phone |
080-26608645 |
| Fax |
080-26608645 |
| Email |
rnagaratna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rita Mhaskar |
| Designation |
Professor |
| Affiliation |
St John Medical College and Hospital |
| Address |
Dept. of OBG
St. Johns Medical College and Hospital
Sarjapur Road
Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
080-22065780 |
| Fax |
|
| Email |
ritamhaskar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Abbas Rakhshani |
| Designation |
Co-Investigator, Senior Research Fellow |
| Affiliation |
SVYASA University |
| Address |
19, Eknath Bhavan
Gavipuram Circle
K.G.Nagar
Bangalore
Bangalore
KARNATAKA
560 019
India |
| Phone |
04542-245022 |
| Fax |
|
| Email |
abbas616@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF AYUSH
Ministry of Health and Family Welfare |
|
|
Primary Sponsor
|
| Name |
AYUSH |
| Address |
DEPARTMENT OF AYUSH
Ministry of Health and Family Welfare
IRCS BUILDINGS
RED CROSS ROAD, NEW DELHI 110001 |
| Type of Sponsor |
Government funding agency |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rita Mhaskar |
Obstetrics and Gynecology Department, Room 10 |
St Johns Medical College and Hospital
Sarjapur Road
Bangalore 560034
Bangalore
KARNATAKA |
080-25532037
ritamhaskar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St Johns Medical College and Hospital Institutional Ethical Review Board |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Preeclampsia, Eclampsia, IUGR, Fetal Death, PIH, Placental Abruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Antenatal Practices |
Medication, Bed Rest, and walking. |
| Intervention |
Yoga |
Simple, stress-reducing practices from 13 weeks gestation to 28th week gestation (16 weeks). The practices included simple asanas, breathing exercises, visualization, guided imagery, and deep relaxation (shavasana) |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women within 8 to 12 weeks of pregnancy and with any of the following risk factors were considered qualified for the study:
Bad obstetrics history
Twin pregnancies
Maternal age between 14 and 20 or between 35 and 45
Obesity (BMI greater than 30)
History of pregnancy complications among blood relatives: sister, mother, or grandmother
|
|
| ExclusionCriteria |
| Details |
Qualified subjects with any of the following disorders were excluded from the study:
Severe renal, hepatic or gallbladder, or heart disease.
Structural abnormalities in the reproductive system.
Hereditary anemia (such as sickle cell disease) or hemoglobin S-C disease,
Seizure disorders.
Taking chemotherapy drugs.
Having sexually transmitted diseases including syphilis and HIV infection.
Having any medical conditions that prevent them from safely and effectively practicing the interventions (e.g. spinal deformities or any DSM-IV type I axis psychiatric condition)
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Maternal Blood Pressure
Protein in urine, Platelet count, blood uric acid, Doppler parameters, stress instruments, and Blood markers: TNF-alpha;, IL-6, IL-10, sFlt-1, E-selectin, endoglin, and adiponectin |
12th week, 20th week, and 28th week gestation |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Measure of stress:
Objectively: Heart Rate Variability (HRV) and subjectively: Perceived Stress Scale (PSS) |
13th week, 20th week, 28th week gestation |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
In process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objectives: Previous studies have shown yoga to be effective in improving outcomes in normal pregnancies. This randomized controlled single-blinded trial investigated its effects on the outcomes of high-risk pregnancies. Methods: 68 high-risk pregnant women were randomized into two groups: yoga and control. The yoga group (n=30) received standard care plus one hour of meditative yoga sessions, three times a week, from the 12th to 28th week gestation. The control group (n=38) received only standard care. Fetal measurements and pregnancy complications were assessed. Results: Significantly fewer SGA babies were born in the study group (p=0.033). Both the APGAR1 and APGAR5 scores were significantly improved in the yoga group (p=0.006). Significantly fewer PIH, preeclampsia, GDM and IUGR cases were observed in the yoga group (p= 0.018, 0.042, 0.049, 0.05 respectively). The reported cases of eclampsia, CPD, PROM, and EMCS, while improved, were not statistically significant (p=0.157, 0.317, 0.919 and 0.617, respectively). Conclusion: Yoga is effective in management of some pregnancy complications in high-risk pregnancies and can improve pregnancy outcomes. |