| CTRI Number |
CTRI/2024/10/075280 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of preoperative per rectal misoprostol in reducing intraoperative blood loss in LSCS |
|
Scientific Title of Study
|
A randomized control study to determine the efficacy of preoperative per rectal misoprostol in reducing blood loss in LSCS |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srinidhi Bhat |
| Designation |
Junior resident |
| Affiliation |
Karnataka institute of medical science |
| Address |
Department of OBG,KMCRI, Hubli
Department of OBG,KMCRI, Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
07760319180 |
| Fax |
|
| Email |
srinidhipmbhat2897@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR S V Nachikhata |
| Designation |
Professor and unit chief |
| Affiliation |
Karnataka institute of medical science |
| Address |
Department of OBG,KMCRI,Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9343882242 |
| Fax |
|
| Email |
svn1974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S V Nachikhata |
| Designation |
Professor and unit chief |
| Affiliation |
Karnataka institute of medical science |
| Address |
Department of OBG,KMCRI,Hubli
Dharwad
KARNATAKA
580021
India |
| Phone |
9343882242 |
| Fax |
|
| Email |
svn1974@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of OBG, KMCRI,Hubli,Karnataka, India,580021 |
|
|
Primary Sponsor
|
| Name |
DR SRINIDHI P M BHAT |
| Address |
Post graduate,Department of OBG,KMCRI,Hubli, Karnataka,India,580021 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Srinidhi P M Bhat |
Karnataka Medical College and research institute |
Maternal operation theatre, department of OBG,KMCRI,Hubli
Dharwad
KARNATAKA |
7760319180
srinidhipmbhat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences Hubballi Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O720||Third-stage hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AMTSL |
10 units of oxytocin intramuscular intraoperatively after the extraction of the baby |
| Intervention |
Per rectal misoprostol |
Preoperative per rectal misoprostol Tab. Misoprostol 800 mcg after successful anesthetic induction of LSCS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Consenting women undergoing lower segment cesarean section in KIMS during study period |
|
| ExclusionCriteria |
| Details |
Women known to have hypersensitivity to prostaglandin. Medical contraindications for prostaglandin. Women not consenting for trial |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of preoperative per rectal misoprostol in reducing intraoperative blood loss in lower segment cesarean section. |
immediate post operative.48 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the use of pre operative misoprostol in reducing the incidence of PPH and there by reducing maternal mortality and morbidity. |
2HRS AFTER LSCS |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2024 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|
Brief Summary
|
This will be a randomized control trial spanning over 18 months, conducted in KIMS HUBLI. A total of 200 women meeting the inclusion criteria with written informed consent will be taken up for the study. Detailed history regarding gravida, parity, gestational age, presence of risk for PPH and other comorbidities and the indication for cesarean will be noted . Complete clinical and laboratory evaluation will be done. Eligible women will be randomized into 2 groups. Women in study group will receive 800mcg misoprostol per rectally immediately after spinal anesthesia. Caesarean delivery will be performed under spinal anesthesia by senior obstetricians who will be blind to allocation. 10 IU Oxytocin im will be administered intraoperative to both the groups as per the standard AMTSL practice . Estimation of blood loss will be started after uterine incision. During the operation an isolated suction will be used for evacuation of amniotic fluid through a small incision over the uterus, and another one will be used for collection of blood. A dedicated assistant will be responsible for collection of blood and amniotic fluid in 2 separate suction sets, and for weighing surgical towels before and after operation. Gravimetric method will be used to determine the blood loss i.e the weight difference of 1gm between pre operative mops and post operative mops will be taken as 1 ml of blood loss. The collected blood in suction bottle would be added to the blood in clots and swabs. Blood loss will be calculated and compared in both. Preoperative and post operative hemoglobin and hematocrit values will be used to calculate the overall blood loss caused by the procedure. |