| CTRI Number |
CTRI/2014/03/004491 [Registered on: 24/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
21/03/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Addition of 400 microgram misoprotol to routine management of third stage of labour in women at risk for bleeding after delivery. |
|
Scientific Title of Study
|
Efficacy and safety of 400 microgram misoprostol by sublingual route to augment routine management of third stage of labour in high risk women following vaginal delivery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 11/2/202 NMC/Ethi/Gen/p086 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arindam Majumdar |
| Designation |
RESIDENT |
| Affiliation |
NRS MEDICAL COLLEGE ,KOLKATA |
| Address |
138,A.P.C Road, Kolkata-14
Kolkata
WEST BENGAL
700014
India |
| Phone |
9231509828 |
| Fax |
|
| Email |
arindamsutia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPICKLU CHAUDHURI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NRS MEDICAL COLLEGE,KOLKATA |
| Address |
138,A.P.C Road, Kolkata-14
Kolkata
WEST BENGAL
700014
India |
| Phone |
9432277443 |
| Fax |
|
| Email |
picklu.chaudhuri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPICKLU CHAUDHURI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
NRS MEDICAL COLLEGE,KOLKATA |
| Address |
138,A.P.C Road, Kolkata-14
Kolkata
WEST BENGAL
700014
India |
| Phone |
9432277443 |
| Fax |
|
| Email |
picklu.chaudhuri@gmail.com |
|
|
Source of Monetary or Material Support
|
| NRS Medical College ,Kolkata |
|
|
Primary Sponsor
|
| Name |
NRS MEDICAL COLLEGE KOLKATA |
| Address |
138,A.P.C Road, Kolkata-14 |
| Type of Sponsor |
Government medical college |
|
|
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 Arindam Majumdar |
G&O OPD,ROOM NO-64. Kolkata WEST BENGAL |
DEPARTMENT OF G&O,NRS MEDICAL COLLEGE KOLKATA
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
9231509828
arindamsutia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,NRSMCH,KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregant women with known High risk factors for post partum hemorrhage., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Misoprostol 400 microgram |
Sublingual 400 microgram misoprostol and 10 units oxytocin intramuscular within 1 minute of delivery of newborn( second baby in case of twin) |
| Comparator Agent |
Placebo |
sublingual placebo tablets and intramuscular oxytocin 10 IU withiin 1 minute of delivery of newborn( second baby in case of twin) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women with one or more of the high risk factors as
multiple pregnancy
• polyhydramnios
• prolonged labour
• labor augmented by oxytocin.
• H/O PPH in previous pregnancy.
• Post caesarean section (for vaginal delivery)
• Obese patient (BMJ >30)
• Grand multipara
• APH
• Severe preeclampsia/eclampsia.
• Anaemia(hb<10gm%)
|
|
| ExclusionCriteria |
| Details |
Any contraindications for the use of misoprostol and oxytocin such as known hypersensitivity, asthma, epilepsy etc.
Cardiovascular, hepatic, haematological disorders.
Temperature >38ï‚°C
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood loss after delivery and incidence of Post partum Haemorrhage |
From delivery of the newborn to 1 hour after delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Post parum drop of Haemoglobin concentration
2. need for additional oxytocic and blood transfusion
3. complications and side effects |
1. 24 hours after delivery
2. 24 hours after delivery
3. 24 hours after delivery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/03/2013 |
| 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) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study is a randomized double bind placebo controlled trial evaluating the efficacy and safety of 400 microgram misoprostol in addition to routine mangement of third stage of labour with 10 units of intramuscular oxytocin in women with high risk factors for PPH following vaginal delivery.The primary outcome measures are the postpartum blood loss and incidence of PPH. |