| CTRI Number |
CTRI/2009/091/000075 [Registered on: 06/04/2009] |
| Last Modified On: |
24/02/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to compare the effects of Misoprostol(per rectal) and Oxytocin(intravenous infusion)in reducing blood loss in women undergoing caesarean section. |
Scientific Title of Study
Modification(s)
|
A randomised double- blind well controlled clinical trial to compare the efficacy and safety of rectally administered Misoprostol and Intravenous Oxytocin infusion in preventing intraoperative and postpartum blood loss in women undergoing caesarean section. |
| Trial Acronym |
Misoprostol,rectal,blood loss,cesarean section |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrPicklu Chaudhuri |
| Designation |
|
| Affiliation |
|
| Address |
Shyamvihar,Bl-2,Fl2C
RFF-2,Raghunathpur
Kolkata
WEST BENGAL
700059
India |
| Phone |
03325797827 |
| Fax |
|
| Email |
picklu.chaudhuri@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrPicklu Chaudhuri |
| Designation |
|
| Affiliation |
|
| Address |
Shyamvihar,Bl-2,Fl2C
RFF-2,Raghunathpur
Kolkata
WEST BENGAL
700059
India |
| Phone |
03325797827 |
| Fax |
|
| Email |
picklu.chaudhuri@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrPicklu Chaudhuri |
| Designation |
|
| Affiliation |
|
| Address |
Shyamvihar,Bl-2,Fl2C
RFF-2,Raghunathpur
Kolkata
WEST BENGAL
700059
India |
| Phone |
03325797827 |
| Fax |
|
| Email |
picklu.chaudhuri@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Chittaranjan ollege of obstetrics,Gynecology& child Health.37,S.P.Mukherjee Road,Kolkata-26 |
|
Primary Sponsor
Modification(s)
|
| Name |
Chittaranjan Sevasadan HospitalSPMukherjee Road Kolkata |
| Address |
S .P. Mukherjee Road, Kolkata |
| Type of Sponsor |
Government medical college |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| NIL |
not applicable |
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPicklu Chaudhuri |
Department of G&O,Chittaranjan Sevasadan College of Obstetrics ,Gynecology&Child Health. |
37,S.P.MukherjeeRoad,-700026
Kolkata
WEST BENGAL |
03325797827
picklu.chaudhuri@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chittaranjan Sevasadan Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Healthy women without known risk factor for Postpartum Haemorrhage are studied., |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Misoprostol is given rectally after peritonium is opened during LSCS. |
Dose of Misoprostol-800 microgram. |
| Comparator Agent |
Oxytocin infusion started immidiately after delivery of the newborn. |
Dose of Oxytocin-10 units in 500 ml of Ringer Lactate solution. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
women undergoing elective or emergency caesarean section. |
|
| ExclusionCriteria |
| Details |
Antepartum Haemorrhage,Severe Preeclampsia,Prolonged and Obstructed labour,Hb below 8gm/dl,Multiple Pregnancy,Polyhydramnios and associated Myoma of uterus,Cardiovascular,renal ,hepatic and connective tissue disorders. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| blood loss during operation and 8 hours postpartum and change in the hemoglobin 24 hours after delivery. |
Blood loss:during operation and upto 8 hours postpartum.
Hb :predelivery and 24 hours after delivery. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| need for additional uterotonic, incidence of side effects and complications, need for blood transfusion and cost of oxytocic. |
Upto 24 hours postpartum. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="0"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/12/2007 |
| 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
Modification(s)
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in the Int. J of Gynecol obstet,vol 109(2010),25-29 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a randomised ,double -blind, parallel group trial comparing the widely used intravenous Oxytocin infusion and rectally adminstered Misoprostol in low risk women undergoing caesarean section with a primary outcome measure of assessing the intraoperative and postpartum blood loss over next 8 hours and change in Hb%.Secondary outcome measures ,additional oxytocic requirement,need for blood transfusion,side effects and cost -efectiveness of the drugs. |