| CTRI Number |
CTRI/2023/09/057415 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Body pain in women immediately after delivery of the child |
|
Scientific Title of Study
|
Factors associated with musculoskeletal pain among women in immediate postpartum period |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arshi Khanam |
| Designation |
Post-graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900721600 |
| Fax |
|
| Email |
arshi.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Arshi Khanam |
| Designation |
Post-graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900721600 |
| Fax |
|
| Email |
arshi.mchpmpl2022@learner.manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhamini Krishna Rao |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8660644145 |
| Fax |
|
| Email |
bhamini.kr@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Arshi Khanam, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka India |
|
|
Primary Sponsor
|
| Name |
Arshi Khanam |
| Address |
Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education Manipal |
| 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 |
| Dr Bhamini Krishna Rao |
Kasturba Hospital |
Department of Obstetrics and Gynecology, Wards no. WH2, WH4,and WH5 3rd floor Women and Children Block, Manipal
Udupi
KARNATAKA |
8660644145
bhamini.kr@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O909||Complication of the puerperium, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida and Multigravida women
Women delivering with normal vaginal delivery and LSCS
Women in immediate postpartum period
Able to read/understand kannada |
|
| ExclusionCriteria |
| Details |
Mothers with preterm infant admitted in NICU​
Postpartum women diagnosed with neoplastic, traumatic, endocrine or systemic diseases
Postpartum depression , diagnosed Psychiatric disorders
Postpartum complications- postpartum hemorrhage, seizures, post-eclampsia​ |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale (NPRS) |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Birth Satisfaction Scale-Revised (BSS-R) |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="266"
Sample Size from India="266"
Final Enrollment numbers achieved (Total)= "266"
Final Enrollment numbers achieved (India)="266" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2023 |
| Date of Study Completion (India) |
11/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Permission to conduct the study is obtained from Institutional Research committee (IRC), MCHP, MAHE and from the Head of Department, Department of Obstetrics and Gynecology, Kasturba Hospital, Manipal. After obtaining the approval from Institutional Ethics Committee (IEC), Kastuba Hospital, Manipal, the study will be registered under the Clinical Trials Registry- India (CTRI). Participants will be screened in accordance with inclusion and exclusion criteria. After explaining the procedure in detail, written informed consent will be received from eligible participants. The demographic details will be recorded and BMI will be calculated. Outcome measures such as Numeric Pain Rating Scale (NPRS), Birth Satisfaction Scale- Revised (BSS-R), and 6-point Self-rated Engorgement scale will be administered on postnatal day (PND-2) for normal delivery women and postoperative day (POD-4) for Lower Segment Cesarean Section (LSCS). The data will be analysed separately for normal vaginal delivery and LSCS. |