| CTRI Number |
CTRI/2025/07/090730 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison between intravenous Calcium Chloride vs only Oxytocin in decreasing blood loss during cesarean delivery |
|
Scientific Title of Study
|
A Randomized Controlled Trial on Administration of intravenous Calcium Chloride in addition to routine Oxytocin in reducing blood loss during cesarean section |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Varsharani167 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varsha Rani |
| Designation |
Junior Resident (Academics) of Obstetrics and Gynaecology department |
| Affiliation |
All india institute of Medical Science, Kalyani |
| Address |
Obstetrics and Gynaecology department, All india institute of medical science, Kalyani, Saguna NH-34 Connector, Basantapur, Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
9582817504 |
| Fax |
|
| Email |
varsharani167@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avir Sarkar |
| Designation |
Assistant Professor of Obstetrics and Gynaecology |
| Affiliation |
AIIMS Kalyani |
| Address |
Obstetrics and Gynaecology department, AIIMS Kalyani, Saguna NH-34 Connector, Basantapur, Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
6280765384 |
| Fax |
|
| Email |
avir.obg@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avir Sarkar |
| Designation |
Assistant Professor of Obstetrics and Gynaecology |
| Affiliation |
AIIMS Kalyani |
| Address |
Obstetrics and Gynaecology department, AIIMS Kalyani, Saguna NH-34 Connector, Basantapur, Kalyani
Nadia
WEST BENGAL
741245
India |
| Phone |
6280765384 |
| Fax |
|
| Email |
Avir.obg@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Kalyani, Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal,India 741245 |
|
|
Primary Sponsor
|
| Name |
Varsha Rani |
| Address |
AIIMS Kalyani, Saguna NH-34 Connector, Basantapur, Kalyani, West Bengal 741245 |
| Type of Sponsor |
Other [Self] |
|
|
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 Varsha Rani |
All india institute of medical science, Kalyani |
Obstetrics and Gynaecology department, AIIMS Kalyani, Saguna,NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL |
9582817504
varsharani167@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS KALYANI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O678||Other intrapartum hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Iv Calcium chloride |
Receive IV calcium chloride (10% solution, 1 g) during cesarean section through iv route over 10 minutes along with the routine administration of oxytocin (10-20 units in 500-1000 mL of saline) iv infusion over 30minutes
|
| Comparator Agent |
Placebo |
Receive the routine administration of oxytocin (10-20 units in 500-1000 mL of saline) iv infusion over 30minutes
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
a) Women aged 18-40 years.
b) Women who underwent elective or emergency cesarean section at the study institution.
c) Singleton pregnancies with no known placental or uterine abnormalities.
d) Women who received either IV calcium chloride with oxytocin (group 1) or only oxytocin (group 2) as part of routine clinical management.
|
|
| ExclusionCriteria |
| Details |
a) Women with known allergies or contraindications to calcium chloride.
b) Women with pre-existing cardiac arrhythmias or significant cardiovascular disease.
c) Women with pre-existing coagulopathies or those who are on anticoagulant therapy.
d) Women with uterine anomalies, placenta previa, or other conditions that may confound blood loss.
e) Women who had a hysterectomy or other major surgical interventions during the cesarean.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total blood loss during cesarean section as measured by the volume of blood collected in suction containers and the weight of surgical sponges (considering 1 g of weight = 1 mL of blood). |
18 monnths |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for blood transfusion due to excessive blood loss (if applicable).
|
18 months |
Uterine tone post-delivery (evaluated by the obstetrician).
|
18 months |
Incidence of uterine atony, requiring additional uterotonic drugs.
|
18 months |
Maternal complications: Hypotension, arrhythmias, or hypercalcemia.
|
18 months |
Length of hospital stay and recovery outcomes.
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 |
|
Date of First Enrollment (India)
|
13/07/2025 |
| 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 Applicable |
| 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 - All of the individual participant data collected during the trial, after de-identification.
- 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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [varsharani167@gmail.com].
- For how long will this data be available start date provided 02-04-2028 and end date provided 31-12-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This randomized trial will provide valuable information regarding whether the addition of IV calcium chloride to routine oxytocin use during cesarean sections can reduce blood loss and improve maternal outcomes. If successful, this study could provide valuable insights into adjunctive treatments to improve the management of blood loss during cesarean deliveries, potentially influencing clinical practice to enhance patient safety and reduce maternal morbidity |