| CTRI Number |
CTRI/2011/10/002064 [Registered on: 14/10/2011] Trial Registered Prospectively |
| Last Modified On: |
13/10/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can Yoga decrease the occurrence of high blood pressure in pregnancy in certain women prone for it? |
|
Scientific Title of Study
|
Effect of mid trimester yoga on the incidence of Preeclampsia in high risk women |
| Trial Acronym |
YIPPE (Yoga in Prevention of Pre Eclampsia) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1125-0577 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manikandan K |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynecology, JIPMER,
Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132296275 |
| Fax |
|
| Email |
manimmc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manikandan K |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynecology, JIPMER,
Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132296275 |
| Fax |
|
| Email |
manimmc@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Manikandan K |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynecology, JIPMER,
Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132296275 |
| Fax |
|
| Email |
manimmc@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K Manikandan |
| Address |
Department of Obstetrics and Gynecology, JIPMER,
Dhanvantari Nagar, Pondicherry 605006 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| K Manikandan |
Department of Obstetrics and Gynecology |
OPD no. 69, JIPMER OPD block,
Dhanvantari Nagar,
Pondicherry
PONDICHERRY |
04132296275
manimmc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Preeclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Usual Care |
Women identified at high risk for Gestational Hypertension/Preeclampsia would be managed as per standard protocols including frequent visits, growth scans and aspirin 150mg per day started before 16 weeks. These will also be applicable to the yoga group (interventional group) |
| Intervention |
Yoga:
1. Warm up and loosening practices
2. Breath body coordination practices
3. Pranayama practices
4. Relaxation Practices |
1. Hastha, Pada, Shirsha and Kati Jathis along with Nasarga Mukha Bhastrika
2. Talasana, Ardhakati Chakrasana, Chatushpada and Vyagraha Pranayama, Baddhakonasana with Aswini Mudra, Balasana and Pad uttana series with bent knees
3.Pranava pranayama, Chandranadi pranayama, and Bhramari Pranayama
4.Kaya Kriya and Savitri Pranayama in Shavasana |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women who present at gestational age less than 16 weeks and having any of the following high risk attributes:
1. Chronic hypertension: [defined as blood pressure equal to or more than 140/90 detected prepregnancy or before 20 weeks of gestation]
2. Gestational hypertension/Preeclampsia/Eclampsia in any previous pregnancy
3. History of abruption or unexplained IUGR in any previous pregnancy
4.First trimester uterine artery PI more than the 90th centile [using the Fetal Medicine Foundation calculator]
|
|
| ExclusionCriteria |
| Details |
1. Patients with musculoskeletal disorders or defects preventing satisfactory performance of yoga techniques
2. Women with cardiac/chronic pulmonary disease preventing satisfactory performance of yoga techniques
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occurrence of Gestational Hypertension/Preeclampsia |
discharge from hospital after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of Preeclampsia |
discharge from hospital after delivery |
| Gestational Length |
delivery |
| Maternal Mortality |
hospital stay |
| Onset of Gestational Hypertension-Preeclampsia |
discharge from hospital after delivery |
| fetal growth restriction |
nil |
| Neonatal Intensive Care Unit admission |
Discharge from hospital after delivery |
| Neonatal Mortality |
Discharge from hospital after delivery |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/10/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| Background: Preeclampsia is a potentially life threatening complication of pregnancy. In JIPMER, the number of preeclamptic women in 2009 was 2015.In the past several attempts to prevent this disastrous complication have yielded little success. Although the exact etiopathogenesis of the disease is still elusive, the central pathology is global vasospasm. Outside of pregnancy, yoga has been shown to decrease both systolic and diastolic blood pressure in essential hypertension, a disease with similar pathology. Yoga has also been shown to decrease the stress levels which may contribute to the pathogenesis of vascular spasm. Yoga is safe in pregnancy as has been shown by numerous studies of the effect of yoga on labor and birth. Yoga in pregnancy has also been shown to have a significant beneficial effect on fetal growth. There are no studies specifically addressing the issue of preventive effect of yoga on pregnancy induced hypertension.
Hypothesis: Yoga, when practiced in mid pregnancy decreases the incidence of preeclampsia in high risk women | Objectives (a) Overall (b) Specific | To assess the effect of Yoga in Preeclampsia Prevention 1. To assess the effect of yoga in mid pregnancy on the occurrence of preeclampsia in women at high risk of developing preeclampsia 2. To assess the effect of yoga on the maternal and perinatal outcome in women at high risk of developing preeclampsia |
| |