| CTRI Number |
CTRI/2025/10/096393 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Research on the effect of low-dose versus usual-dose oxytocin in preventing blood loss during cesarean delivery. |
|
Scientific Title of Study
|
A randomized controlled, open-label, non-inferiority trial to compare the efficacy and safety of low-dose oxytocin versus standard-dose oxytocin in achieving adequate uterine tone and preventing postpartum haemorrhage during scheduled cesarean deliveries |
| 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 kratika jha |
| Designation |
junior resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of obstetrics and gynaecology,3rd floor nehru block, pgimer, chandigarh, sector 12
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6264958400 |
| Fax |
|
| Email |
kratikajha369@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aashima arora |
| Designation |
Additional professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of obstetrics and gynaecology,3rd floor nehru block, pgimer, chandigarh, sector 12
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
99155 01844 |
| Fax |
|
| Email |
aashicool84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kratika jha |
| Designation |
junior resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Department of obstetrics and gynaecology,3rd floor nehru block, pgimer, chandigarh, sector 12
Chandigarh
CHANDIGARH
160012
India
CHANDIGARH
160012
India |
| Phone |
6264958400 |
| Fax |
|
| Email |
kratikajha369@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research Chandigarh |
| Address |
Postgraduate Institute of Medical Education and Research, Chandigarh
160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 kratika jha |
Postgraduate Institute of Medical Education and Research, Chandigarh |
Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH |
6264958400
kratikajha369@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
low dose oxytocin |
1 IU IV bolus over 1 minute after delivery of fetus, followed by maintenance infusion at 2.5–7.5 IU/hr (titrated hourly) for 4 hours using infusion pump. Rescue dose: 3 IU IV if uterine tone inadequate.
|
| Comparator Agent |
standard dose oxytocin |
5 IU IV bolus over 1 minute after delivery of fetus, followed by 10–20 IU in 500 ml Ringer’s lactate over 4 hours. Rescue dose: 3 IU IV if uterine tone inadequate.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18–45 years
2. Singleton pregnancy
3. Scheduled cesarean delivery at 37–40 weeks
4. Regional anesthesia planned
5. Willing to participate and provide written informed consent |
|
| ExclusionCriteria |
| Details |
refusal to consent
asa physical status more than 3
conditions increasing risk of uterine atony
cardiac, hepatic,autoimmune,renal disorders
uncontrolled hypertension, diabetes
contraindications to regional anaesthesia
cesarean performed during labor |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| adequate uterine tone on likert scale more than 2 at 5 minutes post oxytocin administration |
5 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total intraoperative blood loss
2. Change in hematocrit at 24 hours
3. Incidence of atonic postpartum haemorrhage
4. Requirement for additional uterotonics
5. Maternal haemodynamic changes (HR, BP)
6. Adverse drug reactions
7. Need for blood transfusion |
Up to 24 hours postoperative |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kratikajha369@gmail.com].
- For how long will this data be available start date provided 31-12-2026 and end date provided 31-12-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Postpartum haemorrhage (PPH) is a leading cause of maternal morbidity and mortality, particularly after cesarean deliveries. Oxytocin is the first-line uterotonic recommended globally to prevent uterine atony and PPH. Historically, high prophylactic doses were used, but newer evidence suggests that lower doses may be equally effective with fewer adverse effects. Guidelines such as ERAS 2025 promote individualized, lower-dose regimens to minimize side effects like hypotension and tachycardia. However, there is variability in practice, and optimal dosing in low-risk scheduled cesareans remains unclear, especially in Indian settings, necessitating further evaluation through randomized clinical trial This study will provide robust evidence on whether a low-dose oxytocin regimen is non- inferior to the standard dose in achieving adequate uterine tone during scheduled cesarean deliveries. It will also assess the impact on intraoperative blood loss, requirement for additional uterotonics, and maternal hemodynamic stability. By directly comparing both regimens under a randomized, controlled, real-world clinical setting, the findings will help refine oxytocin dosing protocols. The study’s outcomes could support adoption of lower prophylactic doses, improving safety profiles while maintaining efficacy, and may contribute to national and international guideline updates for PPH prevention in cesarean deliveries. |