| CTRI Number |
CTRI/2010/091/006136 [Registered on: 11/01/2011] |
| Last Modified On: |
22/02/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
a clinical trial to study the effects of per rectal misoprostol 400 microgram plus 5 units oxytocin iv and 5 units oxytocin iv in third stage of labour. |
Scientific Title of Study
Modification(s)
|
Comparative study of combined per rectal misoprostol and intravenous oxytocin infusion versus intravenous oxytocin infusion in third stage of labour. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Prabhat Chandra Mondal |
| Designation |
Junior Resident |
| Affiliation |
|
| Address |
B. S Medical College
Bankura
WEST BENGAL
722102
India |
| Phone |
9434438616 |
| Fax |
|
| Email |
prabhatmndl@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Subhendu Dasgupta |
| Designation |
Professor and Head |
| Affiliation |
Professor and Head |
| Address |
Bankura Sammilani Medical College
Bankura
WEST BENGAL
722102
India |
| Phone |
9434358869 |
| Fax |
|
| Email |
subhendu_dasgupta@yahoo.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Prabhat Chandra Mondal |
| Designation |
|
| Affiliation |
|
| Address |
Bankura Sammilani Medical College
Bankura
WEST BENGAL
722102
India |
| Phone |
9434438616 |
| Fax |
|
| Email |
prabhatmndl@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
Primary Sponsor
Modification(s)
|
| Name |
Bankura Sammilani Medical College Hospital |
| Address |
Bankura Sammilani Medical College & Hospital
P.O.& Dist-Bankura
Pin-722101 |
| 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 |
| Prabhat Chandra Mondal |
Bankura Sammilani Medical College |
,-722102
Bankura
WEST BENGAL |
9434438618
prabhatmndl@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical comitee of B. S Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
To detect the efficacy as uterotonic use in the management of third stage of labour, misoprostol 4oo microgram per- rectal plus 5 units oxytocin intravenous will be studied., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oxytocin plus misoprostol |
5 units oxytocin infusion with 4 ml ringer lactate solution plus 400 microgram misoprostol per rectal |
| Comparator Agent |
oxytocin plus placebo tablet |
5 units oxytocin infusion in 4 ml ringer lactate solution iv plus placebo tablet per rectal |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Women who will have spontaneous normal delivery of a live, singleton neonate, and absence of any contraindications for misoprostol or oxytocin use. |
|
| ExclusionCriteria |
| Details |
women delivered by cesarean, or had a history of antepartum hemorrhage or bleeding tendency. The diagnosis of hypertensive disorder with pregnancy or the need for anticoagulants also will serve as exclusion criteria. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Determination of hemoglobin and hematocrit changes between antenatal and post natal level
2.Incidence of post partum haemorrhage and estimation of average blood loss in third stage of labour
3.The length of the third stage of labour
4.The percentage of women requiring manual removal of Placenta and further oxytocin and blood transfusion requirement.
5.The side effects of the drugs
|
a.In first stage and twenty four hours after delivery of placenta, blood will be collected for measurement of hemoglobin and hematocrit.
b.Number of patients will have 500 ml or more blood loss in third stage of labour, patients who will have hemodynamic changes due to blood loss less than 500 ml and require blood transfusion will also be counted.
c. Amount of blood loss in the third stage of labour.
d.Time duration between delivery of fetus and placenta.
e.Number of patients will have retained placenta despite controlled cord traction and uterotonic agent, requiring manual removal of placenta (placenta accreta, percreta and increta will be excluded).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
Target Sample Size
Modification(s)
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
01/07/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/07/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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)?
|
|
Brief Summary
|
A randomised controlled trial between intravenous infusion of oxytocin 5 iu and combined intravenous infusion of oxytocin 5 iu and per rectal misoprostol 400 µg will be studied between two groups of approximately 200 hundred mothers who have normal delivery in Bankura Sammilani Medical College. Active management of third stage of labour will be managed according to the WHO guide lines. Primary outcome measures are incidence of post partum hemorrhage, amount of blood loss in third stage of labour and the difference of hemoglobin and hematocrit levels before and after delivery. Secondary outcomes include the need for additional uterotonics, transfusion, and medication side effects. Data will be statistically described as mean±SD for continuous data, and frequencies and percentages for categorical data, where appropriate. Comparison of quantitative variables between the study groups will be done using the t test for independent samples. The χ2 test will be performed to compare categorical data. P < 0.05 will be considered statistically significant. |