| CTRI Number |
CTRI/2018/09/015665 [Registered on: 10/09/2018] Trial Registered Prospectively |
| Last Modified On: |
06/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Usefulness of early movement after child birth via caesarean section |
|
Scientific Title of Study
|
"Effectiveness of early ambulation on post operative recovery among primiparous post caesarean mothers" |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipanjali Barai |
| Designation |
Student |
| Affiliation |
JIPMER,CON |
| Address |
Nightingale Hostel, room number 345, JIPMER, Dhanvantri Nagar, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7094404687 |
| Fax |
04132272066 |
| Email |
jaldeep.barai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Vahitha S |
| Designation |
Lecturer |
| Affiliation |
CON, JIPMER |
| Address |
College of nursing, JIPMER, puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9840924805 |
| Fax |
04132272066 |
| Email |
vahiarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Vahitha S |
| Designation |
Lecturer |
| Affiliation |
CON, JIPMER |
| Address |
College of nursing, JIPMER, puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9840924805 |
| Fax |
04132272066 |
| Email |
vahiarun@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self funded |
| Address |
Nightingale hostel, room number 345,JIPMER campus, Dhanvantri Nagar |
| 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 |
| Dipanjali Barai |
Jawaharlal Institute of postgraduate Medical Education and Research |
Room no 552, level 4, Women and Child health building
Pondicherry
PONDICHERRY |
7094404687
04132272066
jaldeep.barai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee( Human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O908||Other complications of the puerperium, not elsewhere classified, (2) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Early Ambulation |
In experimental group early ambulation will be initiated after 6 hours of caesarean section for 3 times in a day. Assessment of post operative recovery will be done after the end of the 24 hours. Where as in control group ambulation will be followed as per hospital protocol i,e after 18 hours of surgery |
| Comparator Agent |
Hospital protocol group |
In control group mothers will start ambulation according to hospital protocol i,e after 18 hours and they will be assessed with same assessment sheet for 1st five post operative days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
mothers who have undergone caesarean section for the first time, those who have undergone under spinal anesthesia and those who can understand verbal communication |
|
| ExclusionCriteria |
| Details |
mothers those who have other medical and gynecological complication, mother who have undergone through general anesthesia, mother who have cardiac problem, magnesium sulfate therapy, immediate postpartum complications and those have doctors order for strict bed-rest. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative recovery |
Post operative recovery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early ambulation after surgery |
After 6 hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
Final Enrollment numbers achieved (Total)= "124"
Final Enrollment numbers achieved (India)="124" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/09/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/10/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in International journal of scientific research, has got published in volume 08, issue 09, September 2019 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
I did a study of effectiveness of early ambulation on post operative recovery. For that i have used randomized control group. My sample size was 124, 62 in each interventional and control group. In intervention group i have provided ambulation after 6 hours of surgery as a intervention. I have ambulted thrice in day for 1st 5 post operative days. After every 24 hours i have assessed post operative recovery by structured observational schedule. Before ambulation i assesed pain by numeric pain rating scale. In control group early ambulation was not provided instead hospital protocol of ambulation was followed for them and same assessment sheet was be used to assess the post operative recovery. |