| CTRI Number |
CTRI/2023/04/051527 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational study |
| Study Design |
Other |
|
Public Title of Study
|
patterns of vaginal bleeding in puerperal women and its significance |
|
Scientific Title of Study
|
clinico demographic determinants of various patterns of vaginal bleeding in puerperal women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Chowdary |
| Designation |
junior resident |
| Affiliation |
Kasturba medical college,MAHE,Manipal |
| Address |
Kasturba Medical Hospital,
Department of Obstetrics and Gynaecology, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7731926774 |
| Fax |
|
| Email |
priyankachowdary2205@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamala G |
| Designation |
Professor and Unit Chief |
| Affiliation |
Kasturba medical college,MAHE,Manipal |
| Address |
Kasturba Medical Hospital,
Department of Obstetrics and Gynaecology, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyamala G |
| Designation |
Professor and Unit Chief |
| Affiliation |
Kasturba medical college,MAHE,Manipal |
| Address |
Kasturba Medical Hospital,
Department of Obstetrics and Gynaecology, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college, Manipal |
|
|
Primary Sponsor
|
| Name |
priyanka |
| Address |
Kmc,manipal |
| Type of Sponsor |
Other [] |
|
|
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 |
| priyanka |
Kasturba Medical College, |
Department of Obstetrics and Gynaecology, Manipal ,576104
Udupi
KARNATAKA |
7731926774
priyankachowdary2205@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and hospital -institutional ethics committee 2 student research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
vitally stable postpartum women |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
post partum women |
|
| ExclusionCriteria |
| Details |
patients who do not wish to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to know the patterns of vaginal bleeding in puerperal women |
up to 6 weeks post delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to know any deviation from normal patterns and to identify any new outcome |
up to 6 weeks post delivery |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="172" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To observe various patterns of vaginal bleeding in puerperal women and to correlate them with antenatal and intrapartum demographic variables |