| CTRI Number |
CTRI/2022/05/042690 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
15/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess use of abdominal binder after cesarean section on maternal comfort and functional outcome |
|
Scientific Title of Study
|
A randomised control trial to assess the effectiveness of abdominal binder use after cesarean section on maternal comfort and functional outcome among women admitted in obstetric units of PGIMER, chandigarh, 2021-23 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neeta Devi |
| Designation |
M.sc nursing student |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
National institute of nursing,room no. 211, PGIMER, chandigarh
UT
National institute of nursing,room no. 211, PGIMER, chandigarh
UT
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7973900492 |
| Fax |
|
| Email |
neetachoudhary797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Dutta |
| Designation |
Lecturer |
| Affiliation |
NINE, PGIMER, CHANDIGARH |
| Address |
ROOM NO. 120,NATIONAL INSTITUTE OF NURSING EDUCATION, PGIMER
CHANDIAGRH
UT
ROOM NO. 120, NATIONAL INSTITUTE OF NURSING EDUCATION, PGIMER
CHANDIGARH
UT
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
987258465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Dutta |
| Designation |
Lecturer |
| Affiliation |
NINE, PGIMER, CHANDIGARH |
| Address |
Room NO. 120, NATIONAL INSTITUTE OF NURSING EDUCATION, PGIMER
CHANDIAGRH
UT
Room no. 120, NATIONAL INSTITUTE OF NURSING EDUCATION, PGIMER
CHANDIGARH
UT
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
987258465 |
| Fax |
|
| Email |
monika.dutta75@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
NEHRU HOSPITAL,PGIMER, CHANDIGARH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| NEETA DEVI |
PGIMER ChANDIGARH |
Room No.3D, CLR extention, PGIMER, CHANDIGARH
Chandigarh
CHANDIGARH |
7973900492
neetachoudhary797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE,PGIMER,CHANDIGARH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O754||Other complications of obstetric surgery and procedures, (2) ICD-10 Condition: O754||Other complications of obstetric surgery and procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Application of abdominal binder |
Post cesarean section women will use abdominal binder during breast feeding, mobilization and activities of daily living for 1/2 to 1hr and will be assessed for maternal comfort and functional outcome at 8hr, 24 hr, 48 hr, at discharge and at first follow up. |
| Comparator Agent |
control group will be given routine care |
control group will be given routine care as prescribed by doctor and will be assessed for maternal comfort and functional outcome |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Post Cesarean Section women with spinal anaesthesia
2. Those who are willing participate in the study
|
|
| ExclusionCriteria |
| Details |
• Women with cardiopulmonary, neuromuscular and mental disorders
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcomes will be numeric pain rating scale-assessing pain, symptom distress scale (SDS)-assessing distress |
primary outcome will be post ceasarean pain and distress and will be assessed at post ceasarean 8hr, 24 hr, 48hr, at the time of discharge and 1st follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome will be functional outcome including mobolization assessed by 6minute walk test, self care activities assessed by barthal index scale and maternal satisfaction scale
|
Secondary outcome will be assessed at post ceasarean 8hr, 24 hr, 48hr, at the time of discharge and 1st follow-up |
|
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Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
31/05/2022 |
| 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="0"
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)?
Response - NO
|
|
Brief Summary
|
Introduction and need: According to WHO report the incidence of cesarean section rate in worldwide is from 15-20%. The maternal mortality after cesarean section is always greater than after vaginal delivery. Indian data reflect increase in cesarean section delivery rates similar to those observed in the rest of the world. A cesarean section can make it less likely that a women will initiate breastfeeding , more likely will stop within month. Physiological changes and abdominal pain raise due to increase in difficulty to establish breastfeeding. Pain control is a major concern after cesarean section because the intense nature of pain interfere with the women’s ability to move and initiate breast feeding. A growing body of evidence suggest that using multimodal strategies like optimal pain relief, stress reduction and mobilization to implement an enhanced recovery after surgery (ERAS) clinical pathway can speed recovery and reduce length of stay for patients undergoing cesarean section. women who had a cesarean section should receive functional assessments, monitoring and support as part of their post partum care. To recover functioning following a cesarean section effective risk- mitigation intervention should be done, especially for those who are enduring longer surgical procedure. While surgical patients have typically been encouraged to splint the incision with their hands or pillow, any relief provided with these techniques is temporary and unlikely to sustain relief. therefore abdominal binder has important implication for such type of postoperative care. the purpose of present study , therefore is to investigate the effect of incision support using abdominal binder on maternal comfort and functional outcome. As a result concept of enhanced recovery after surgery which more widely embrace around the world has not been introduced in the gynecological surgeries where the abdominal binder can be one of the incision supportive device for optimum postnatal care.
Objectives: 1. To develop and implement a protocol on use of abdominal binder after cesarean section among women admitted in obstetric units of PGIMER, Chandigarh 2. To assess the effectiveness of abdominal binder use after cesarean section on maternal comfort and functional outcomes among women admitted in obstetric units of PGIEMR, Chandigarh
Protocol of application of abdominal binder after cesarean section: A protocol on application of abdominal binder will be conducted during the study during intervention phase. The protocol will be prepared in the form of booklet. the booklet contain all the information regarding procedure to use abdominal binder after cesarean section |