| CTRI Number |
CTRI/2010/091/001054 [Registered on: 08/07/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of Condom catheter balloon to control excessive bleeding after childbirth. |
|
Scientific Title of Study
|
Evaluation of Uterine tamponade using condom catheter balloon in management of nontraumatic postpartum hemorrhage |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Asmita Muthal Rathore |
| Designation |
|
| Affiliation |
|
| Address |
217, DG III
Vikaspuri
New Delhi
DELHI
110018
India |
| Phone |
011 28531848 |
| Fax |
|
| Email |
asmita.rathore@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Asmita Muthal Rathore |
| Designation |
|
| Affiliation |
Maulana Azad Medical College, New Delhi |
| Address |
217, DG III
Vikaspuri
New Delhi
DELHI
110018
India |
| Phone |
011 28531848 |
| Fax |
|
| Email |
asmita.rathore@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Gupta |
| Designation |
|
| Affiliation |
|
| Address |
C-1/4A yamuna Vihar
New Delhi
DELHI
110054
India |
| Phone |
011 22914305 |
| Fax |
|
| Email |
sonali_2706@yahoo.co.in |
|
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Source of Monetary or Material Support
|
| Department of obstetrics and gynecology, Maulana Azad Medical College, New Delhi |
|
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Primary Sponsor
|
| Name |
nil |
| Address |
|
| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A M Rathore |
Department of obstetrics and gynecology, Maulana Azad Medical College, NewDelhi |
,-
|
09968604345
asmita.rathore@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College, New Delhi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
postpartum hemorrhage, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
|
| Intervention |
uterine tamponade with condom catheter balloon |
8-48 hours |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Post partum hemorrhage not responding to medical management (appropriate doses of oxytocics and prostaglandins) |
|
| ExclusionCriteria |
| Details |
1. Bleeding due to genital tract trauma and retained placental tissue
2. Known allergy to latex
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Time required to stop bleeding after tamponade is applied |
control of hemorrhage |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Need for additional surgical measures eg devascularization ,B Lynch, hysterectomy |
unstable hemodynamic status of mother |
|
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Target Sample Size
|
Total Sample Size="15"
Sample Size from India=""
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/10/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
tamponade created at predefined point. Primary outcomes noted. If successful, tamponade continued for 8-48 hours with defined monitoring. Tamponade removed after criterias fulfilled. Secondary outcomes noted. |