| CTRI Number |
CTRI/2014/08/004910 [Registered on: 21/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
08/12/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the efficacy of the drug misoprostol administered rectally in reducing excessive bleeding after normal delivery |
Scientific Title of Study
Modification(s)
|
A study to assess the role of rectal misoprostol when combined with standard oxytocin to prevent postpartum haemorrhage in vaginal delivery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranjula golda lysander R |
| Designation |
Post graduate student |
| Affiliation |
Dr.S.M.C.S.I.Medical college |
| Address |
Department of Obstetrics and Gynaecology
Dr.S.M.C.S.I.Medical College
Karakonam
Thiruvananthapuram
Thiruvananthapuram
KERALA
695504
India |
| Phone |
9443253672 |
| Fax |
|
| Email |
ranjulasandeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Nair |
| Designation |
Associate Proffesor |
| Affiliation |
Dr.S.M.C.S.I.Medical college |
| Address |
Department of Obstetrics and Gynaecology
Dr.S.M.C.S.I.Medical College
Karakonam
Thiruvananthapuram
Thiruvananthapuram
KERALA
695504
India |
| Phone |
9447052597 |
| Fax |
|
| Email |
drlnair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjula golda lysander R |
| Designation |
Post graduate student |
| Affiliation |
Dr.S.M.C.S.I.Medical college |
| Address |
Department of Obstetrics and Gynaecology
Dr.S.M.C.S.I.Medical College
Karakonam
Thiruvananthapuram
Thiruvananthapuram
KERALA
695504
India |
| Phone |
9443253672 |
| Fax |
|
| Email |
ranjulasandeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.S.M.C.S.I.Medical college
Karakonam695504 |
|
|
Primary Sponsor
|
| Name |
DrSMCSIMedical college |
| Address |
Dr.S.M.C.S.I Medical college
Karakonam 695504
Trivandrum District
kerala |
| Type of Sponsor |
Private 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 Ranjula Golda Lysander R |
Labour Room |
Department of Obstetrics and Gynaecology,
Division-Labour Room
Room no -2
I Floor,
Surgery and Maternity Complex,
Dr SM CSI Medical College,
Karakonam. 695504
Thiruvananthapuram
KERALA |
9443253672
ranjulasandeep@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee, Reg.No.ECR/178/Inst/KE/2013 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Women with singleton pregnancy undergoing normal vaginal delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
misoprostol 400 micrograms stat |
400 microgram of misoprostol administered rectally |
| Comparator Agent |
Placebo |
Lactose tablets |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
women with singleton pregnancy
cephalic presentation
>28 weeks of gestational age
Hb>10gms |
|
| ExclusionCriteria |
| Details |
patients undergoing cesarean section and instrumental delivery
malpresentation
multiple pregnancy
past history of post partum haemorrhage
coagulopathies
heart disease/renal disease
placenta previa/abruptio placenta |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| fall in haemoglobin and PCV levels |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of third stage of labour
|
1 hour |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
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)
|
01/01/2014 |
| 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="0"
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
|
This study is a randomized double blind placebo controlled trial to find the efficacy of 400mcg of rectal Misoprostol given after the delivery of the baby (in addition to standard dose of 10 units Oxytocin IM injection), in reducing postpartum haemorrhage in 320 patients undergoing vaginal delivery in Dr SM CSI Medical College Hospital for a period of one year.
The primary outcome measures will be fall in haemoglobin and PCV levels after 24 hours of delivery.
The secondary outcome will be duration of third stage of labour
|