| CTRI Number |
CTRI/2025/07/091359 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To Compare The Timing of Intravenous Oxytocin Administration To Minimize Blood Loss During First Trimester Evacuation |
|
Scientific Title of Study
|
A Comparative Study of Timing of Intravenous Oxytocin Administration To Minimize Blood Loss During First Trimester Evacuation (Surgical Termination of Pregnancy) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hanswahini Garg |
| Designation |
Junior Resident |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
DEPT OF OBG,
Sikkim Manipal Institute Of Medical Sciences
Central Referral Hospital
5th Mile Tadong
Upper Tadong
Gangtok
Sikkim
737102
East
SIKKIM
737102
India |
| Phone |
9463979321 |
| Fax |
|
| Email |
hanswahini18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Pradhan |
| Designation |
HOD and Professor, OBG |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Dept of OBG,
Sikkim Manipal Institute Of Medical Sciences
Central Referral Hospital
5th Mile Tadong
Upper Tadong
Gangtok
Sikkim
737102
East
SIKKIM
737102
India |
| Phone |
9434485334 |
| Fax |
|
| Email |
anup.p@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hanswahini Garg |
| Designation |
Junior Resident |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Dept of OBG
Sikkim Manipal Institute Of Medical Sciences
Central Referral Hospital
5th Mile Tadong
Upper Tadong
Gangtok
Sikkim
737102
East
SIKKIM
737102
India |
| Phone |
9463979321 |
| Fax |
|
| Email |
hanswahini18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sikkim Manipal Institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
SMIMS |
| Address |
Department Of Obstetrics And Gynaecology,
Central Referral Hospital,
Sikkim Manipal Institute Of Medical Sciences
5th Mile Tadong
Tadong
Gangtok
Sikkim |
| 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 Hanswahini Garg |
Sikkim manipal Institute of medical sciences |
Dept of OBG, SMIMS, GANGTOK, SIKKIM
East
SIKKIM |
9463979321
hanswahini18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IV Oxytocin |
Starting IV Oxytocin 10 Units in 200ml IVF-RL after 10 minutes Of Starting Suction Evacuation. |
| Intervention |
IV Oxytocin |
Starting IV Oxytocin 10 Units in 200ml IVF-RL before 10 minutes Of Starting Suction Evacuation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. All antenatal women with confirmed first trimester abortion. |
|
| ExclusionCriteria |
| Details |
1. Prior anticoagulant treatment or history of coagulopathy,
2. Patients who donot give consent to participate in this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Administration of oxytocin prior to suction and evacuationof First trimester abortion is more efficacious in reducing blood loss. |
One day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/08/2025 |
| 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 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 comparative study investigates the optimal timing of intravenous oxytocin administration to reduce blood loss during first- rimester surgical termination of pregnancy evacuation. Oxytocin, a uterotonic agent is commonly used to promote uterine contraction and minimize hemorrhage. The study evaluates the effectiveness of administering oxytocin at different time points 10 minute before and after 10 minute of starting the procedure on post-procedure blood loss. The study supports adjusting the timing of oxytocin infusion as a simple, cost effective strategy to improve safety outcomes during early surgical abortions. |