| CTRI Number |
CTRI/2023/09/057173 [Registered on: 01/09/2023] Trial Registered Prospectively |
| Last Modified On: |
29/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study for efficacy and safety of insertion of ESM UBT(for prevention of PPH) with IM oxytocin 10 IU versuss only IM oxytocin 10 IU |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF SAFETY AND EFFICACY OF PROPHYLACTIC INSERTION OF DR.BURKES EVERY SECOND MATTERS UTERINE BALLOON TAMPONADE(ESM-UBT) WITH I.M OXYTOCIN VS ONLY I.M OXYTOCIN FOR PREVENTION OF ATONIC PPH IN 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 D SANTHOSHI |
| Designation |
PG STUDENT |
| Affiliation |
SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
OPD NO 2 SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER BANGARAMMA SAJJAN CAMPUS VIJAYAPURA.
Bijapur
KARNATAKA
586103
India |
| Phone |
7416843889 |
| Fax |
|
| Email |
santhud77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJASRI YALIWAL |
| Designation |
Associate Professor |
| Affiliation |
SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
OPD NO 2 SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER BANGARAMMA SAJJAN CAMPUS VIJAYAPURA.
Bijapur
KARNATAKA
586103
India |
| Phone |
9845152240 |
| Fax |
|
| Email |
ryaliwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR D SANTHOSHI |
| Designation |
PG STUDENT |
| Affiliation |
SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER BANGARAMMA SAJJAN CAMPUS VIJAYAPURA.
Bijapur
KARNATAKA
586104
India |
| Phone |
7416843889 |
| Fax |
|
| Email |
santhud77@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER SHRI BANGARAMMA SAJJAN CAMPUS VIJAYAPURA 586103 |
|
|
Primary Sponsor
|
| Name |
Dr D SANTHOSHI |
| Address |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER SHRI BANGARAMMA SAJJAN CAMPUS VIJAYAPURA 586103 |
| 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 |
| SANTHOSHI |
Shri B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
OPD NO 2 SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER SHRI BANGARAMMA SAJJAN CAMPUS VIJAYAPURA 586103
Bijapur
KARNATAKA |
7416843889
santhud77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical clearance committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O72||Postpartum hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dr BURKES Every Second Matters - Uterine Balloon Tamponade with Inj Oxytocin 10 IU I M |
Group 1 - DR BURKES ESM-UBT Is applied with Inj Oxytocin 10 IU I M given within 5minutes after delivery of baby |
| Comparator Agent |
Inj Oxytocin 10 IU I M |
Group 2- Only Inj Oxytocin 10 IU I M given within one minute after delivery of baby |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Delivering viable babies with high-risk pregnancies who are prone to atonic PPH
Grand multipara
Hydramnios
Pregnancy-induced hypertension
Eclampsia
Gestational Diabetes mellitus
Prolonged labour
Abruption
Deranged coagulation profile
Fibroids
Anemia
Twin pregnancy
|
|
| ExclusionCriteria |
| Details |
Patient with traumatic PPH
Adherent or retained placenta
Uterine rupture
Anomalous uterus
Suspected chorioamnionitis
Purulent infections in cervix, vagina or uterus.
Known advanced cervical cancer
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the blood loss in women in which Dr Burkes UBTwith I.M oxytocin was used to those in whom only I.M oxytocin is used.
|
Measuring Blood loss immediately after inserting UBT post delivery & 48hrs after delivery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety & efficacy of UBT
To study the adverse effects of using UBT
To assess the need for surgical intervention
To assess the need for uterotonic drugs
|
18months |
|
|
Target Sample Size
|
Total Sample Size="226"
Sample Size from India="226"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/09/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
|