| CTRI Number |
CTRI/2016/02/006621 [Registered on: 05/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
05/02/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of antepartum breathing exercises on outcome of labor. |
|
Scientific Title of Study
|
Effectiveness of breathing exercises on outcome of labor. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sushmitha |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nurisng Manipal MU |
| Address |
Manipal College of Nursing Manipal, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
9964144224 |
| Fax |
|
| Email |
sushmitha.karkada@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
sushmitha |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nurisng Manipal MU |
| Address |
Manipal College of Nursing Manipal, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
9964144224 |
| Fax |
|
| Email |
sushmitha.karkada@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
sushmitha |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Nurisng Manipal MU |
| Address |
Manipal College of Nursing Manipal, Manipal University
Udupi
KARNATAKA
576104
India |
| Phone |
9964144224 |
| Fax |
|
| Email |
sushmitha.karkada@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Maternal Health young Professionals project |
|
|
Primary Sponsor
|
| Name |
St Johns Research Institution in colloboration with School of Public Health Harvard Boston |
| Address |
St Johns Research Institute opp BDA complex Koramangala Bangalore 560034 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Sushmitha R Karkada |
Dr TMA Pai Hospital Udupi |
Dr TMA Pai Hospital Near Big Bazar, Taluk office Udupi
Udupi
KARNATAKA |
9964144224
sushmitha.karkada@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant mothers above 36 weeks of gestation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Antepartum breathing exercises |
Both primigravid and multigravid mothers in the interventon group above 36weeks receives antepartum breathing exercises for 6 minutes and are asked to practice it twice daily for minimum 7 days and followed during during labour. |
| Comparator Agent |
Standard care group |
Primigravid and multigravid mothers in both experimental and control group are given standard antenatal care and are followed during labour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Mothers who are in the reproductive age group, above 36 weeks of gestation and without major pregnancy related complicatons |
|
| ExclusionCriteria |
| Details |
Mothers who have pregnancy related complications like PIH, Placenta praevia,twin pregnacny, who have not practised exercises for 7 days and below 36 weeks of gestation |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maternal outcome |
nature and type of deliver, reduction in duration and rate of episiotomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| neonatal outcome |
gestational age,APGAR score, NICU admissions |
|
|
Target Sample Size
|
Total Sample Size="520"
Sample Size from India="520"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/12/2013 |
| 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="3"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
In process of publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
nil |