| CTRI Number |
CTRI/2015/11/006347 [Registered on: 06/11/2015] Trial Registered Prospectively |
| Last Modified On: |
03/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
can early breast feeding reduce pain after normal or caesarean delivery ? |
|
Scientific Title of Study
|
Impact of breast feeding on postpartum pain after vaginal and caesarean delivery among the multiparous women in a selected hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepthi Varghese |
| Designation |
P G Student |
| Affiliation |
Father Muller College of Nursing |
| Address |
Peace cottage
Kallely PO
Pathanamthitta
Peace cottage
Kallely PO
Pathanamthitta
Pathanamthitta
KERALA
689691
India |
| Phone |
9632506758 |
| Fax |
|
| Email |
deepthianoop0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savitha Pramilda Cutinho |
| Designation |
Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Professor
Department of OBG Nursing
Father Muller College of Nursing
Kankanady
Mangalore
Professor
Department of OBG Nursing
Father Muller College of Nursing
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9740687444 |
| Fax |
|
| Email |
savithacutinho@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Brincy DSouza |
| Designation |
Lecturer |
| Affiliation |
Father Muller Charitable Institutions |
| Address |
Department of Paediatric Nursing
Father Muller College of Nursing
Kankanady
Department of Paediatric Nursing
Father Muller College of Nursing
Kankanady
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9886394706 |
| Fax |
|
| Email |
brincy85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College Hospital
FMCI
Kankanady
Mangalore
575002 |
|
|
Primary Sponsor
|
| Name |
Deepthi Varghese |
| Address |
C/O Varghese Philip
Peace Cottage
Kallely PO
Pathanamthitta |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| DrBrincy Loyolla DSouza |
Father Muller Medical College Hospital |
Ward H and G Post Natal section
Father Muller Medical College Hospital
FMCI
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA |
9886394706
brincy85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Postnatal mothers after 12 hours of delivery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Breast Feeding |
A neonate sucking from mothers breast after 6-12 hrs after vaginal delivery and 24 hours after cesarean delivery |
| Comparator Agent |
Cramping pain |
Intermittent pain in the lower abdomen occurred 5 minutes before ,during and 5 minutes after breast feeding. |
| Comparator Agent |
Impact of cesarean incision pain |
Pain due cesarean incision. Pain which occurred after delivery. The wound will be sutured in layers and takes few days to heal. |
| Comparator Agent |
Impact of pain due to episiotomy during normal delivery |
Epistolary is a type incision in perineal area for easy delivery of baby s head and after delivery wound will be sutured .It will take few days to heal. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Multiparous women with
Age above 18 years
Term gestation (more than 37 weeks of gestation)
Prior breastfeeding experience at least with 1 baby
Lactating mothre
Normal vaginal delivery with episiotomy after 12 hours
Lower segmented cesarean delivery after 24 hours
Singleton delivery.
|
|
| ExclusionCriteria |
| Details |
Multiparous women with
Chronic pain
Substance abuse
Classical cesarean incision
Not planning to breastfeed
Psychiatric or cognitive disorders like anxiety or depression
Twins
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the impact of breastfeeding on incisional, perineal and cramping pain after cesarean and vaginal delivery |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To make the women aware about their postnatal pains and healthy side effects on the uterus to help in involution |
1 month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
07/12/2015 |
| 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="1"
Months="10"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objectives of the study is to determine the impact of breastfeeding on incisional, perineal and cramping pain after cesarean and vaginal delivery and to find out the association of postpartum pain with selected variables.
Hypothesises H1:- There is a significant difference in the pain score of multiparous women with normal vaginal delivery and cesarean delivery before, during and after breastfeeding. H2:- There is a significant association of postpartum pain of multiparous women with selected variables. |