| CTRI Number |
CTRI/2019/09/021401 [Registered on: 24/09/2019] Trial Registered Prospectively |
| Last Modified On: |
18/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Outcomes of Different Positions of Breastfeeding among cesarean mothers |
|
Scientific Title of Study
|
A Randomized controlled trial to assess the outcomes of different positions of breastfeeding among cesarean mothers in IPD, AIIMS, Rishikesh |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gunjot |
| Designation |
M.Sc. Nursing 2nd year |
| Affiliation |
AIIMS, Rishikesh |
| Address |
College of Nursing. AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9760496844 |
| Fax |
|
| Email |
gunjotarora95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Prasuna Jelly |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
College of Nursing AIIMS,Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9410103390 |
| Fax |
|
| Email |
prasunajelly@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gunjot |
| Designation |
M.Sc. nursing 2nd year |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Coolege of Nursing, AIIMS,Rishikesh
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9760496844 |
| Fax |
|
| Email |
gunjotarora95@gmail.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gunjot |
| Address |
College of Nursing, AIIMS,Rishikesh |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Gunjot |
AIIMS, Rishikesh |
Inpatient department(IPD) obstetric and gynecology ward
Dehradun
UTTARANCHAL |
9760496844
gunjotarora95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee AIIMS, Rishikesh |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O99||Other maternal diseases classifiable elsewhere but complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
“L†shape high fowler position (between 60 to 90 degree) with extended legs and placing pillow beneath elbow |
Subjects randomly allocated in experimental group A will be provided with the intervention “L†shape high fowler position (between 60 to 90 degree) with extended legs and placing pillow beneath elbow. Primi mother shifted to the ward after caesarean section will be provided with the “L†shape position starting on post of day 1 (2nd day of operation). Depending on the demand of the neonate for the breastfeed position will be provided minimal 6 times a day and mother will also be encouraged to continue the same position in every breastfeed. This will be ensured everyday by the researcher till the discharge of the patient. |
| Comparator Agent |
Side Lying†position in which women lie on the either side next to the baby and placing head on the pillow, one at back and one between the legs. |
Subjects randomly allocated in experimental group B will be provided with the intervention “Side Lying†position in which women lie on the either side next to the baby and placing head on the pillow, one at back and one between the legs. Primi mother shifted to the ward after caesarean section will be provided with the “side lying†position starting on post of day 1 (2nd day of operation) Depending on the demand of the neonate for the breastfeed position will be provided minimal 6 times a day and mother will also be encouraged to continue the same position in every breastfeed. This will be ensured everyday by the researcher till the discharge of the patient. |
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Planned or emergency primipara mothers undergone cesarean section
Primipara mothers underwent cesarean section without any maternal and fetal complications. |
|
| ExclusionCriteria |
| Details |
Primipara mothers with cesarean section who are not willing to sign the informed consent.
Mothers who are not able to follow the instruction due to psychological illness.
Neonate with any abnormality such as cleft palate, cleft lips or any medical 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 |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the outcomes of different positions of the mothers underwent ceasrean section |
1 week |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Breastfeeding outcome,maternal satisfaction,maternal comfort |
1 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2019 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
A Randomized Controlled trial to assess the outcomes of Different Positions of Breastfeeding among Caesarean Mothers in IPD, AIIMS, Rishikesh. Objectives of the study are to compare the breastfeeding outcomes in different positions among mothers underwent caesarean section.To compare the level of comfort in different positions among mothers underwent caesarean section. and to compare the level of maternal satisfaction during breastfeeding in different positions among mothers underwent caesarean section. Need of the study is as in cesarean section mothers having poor latch scoring due to maternal positioning need to have alternative methods of nurturing the infants for effective breastfeeding as effective breastfeeding depends on the proper positioning of mother and baby and attachment of baby to the mother’s breast. Most difficulties can be avoided altogether if good attachment and positioning are achieved at the first and early feeds. Methodology is Quantiative approach, Randomized control trial design. Study setting is Postantal ward AIIMS,Rishikesh with target population Primipara caesarean mothers having convience sampling techniques.
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