| CTRI Number |
CTRI/2025/05/087002 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Does giving calcium during cesarean section help reduce blood loss? A study on High Risk Mothers |
|
Scientific Title of Study
|
Effect of prophylactic intravenous calcium gluconate administration on blood loss in women undergoing cesarean section with risk factor for postpartum hemorrhage - a randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrS Adhithya |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education And Reserch |
| Address |
Department of Anesthesiology and Critical Care, Jipmer, Jipmer Campus Road, Gorimedu, Dhanvantari nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8667637183 |
| Fax |
|
| Email |
artsage17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aswini kuberan |
| Designation |
Associate Professor, |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education And Reserch |
| Address |
Department of Anesthesiology and Critical Care, Jipmer, Jipmer Campus Road, Gorimedu, Dhanvantari nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9914017949 |
| Fax |
|
| Email |
ashdoctor.kuberan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswini kuberan |
| Designation |
Associate Professor, |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education And Reserch |
| Address |
Department of Anesthesiology and Critical Care, Jipmer, Jipmer Campus Road, Gorimedu, Dhanvantari nagar, Puducherry, 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9914017949 |
| Fax |
|
| Email |
ashdoctor.kuberan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER Intramural Research fund |
| Address |
PMER Intramural Research fund, Jawaharlal Institute of Postgraduate Medical Education and Research, Department of Anesthesiology and Critical Care, Jipmer, Jipmer Campus Road, Gorimedu, Dhanvantari nagar, Puducherry, 605006 |
| 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 |
| DrAdhithya |
Jawaharlal Institute of Postgradute Medical Education and Research |
Department of Anesthesiology and Critical Care, Jipmer, Jipmer Campus Road, Gorimedu, Dhanvantari nagar, Puducherry, 605006
Pondicherry
PONDICHERRY |
8667637183
artsage17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute 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 |
| Intervention |
Administration of Calcium gluconate |
Giving 1 gram (10ml) calcium gluconate intravenously over 10 minutes for high risk pregnant women |
| Comparator Agent |
Normal saline |
10 ml of isotonic normal saline will be given intravenously over 10 minutes
Dose-10ml of isotonic saline
Route-Intravenously
Frequency-Once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Age 18 years and more
ASA 2 and 3
Gestational age more than 34 weeks
Planned for c-section under spinal anesthesia
Pregnant females with high risk for blood loss during c-section like previous cesarean section, twin pregnancy, severe obesity, history of previous postpartum hemorrhage
|
|
| ExclusionCriteria |
| Details |
Pregnant females with heart disease, chronic renal disease, placenta accreta sprectum, pregnant females who are taking calcium channel blockers like nifedipine tablets |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of intravenous calcium gluconate with placebo on reduction of intrapartum blood loss in pregnant women posted for cesarean section with risk factor of postpartum hemorrhage. |
At the end of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.verbal numerical rating scale of uterine tone
2.baseline & postoperative hemoglobin
3.baseline & post operative ionized calcium
4.total intraoperative intravenous fluids administered, total dose of vasopressors used & second line utero-tonic used |
1.Baseline, at 5 minutes, 10 minutes, 15 minutes after giving study drug
2. Baseline, at postoperative day 1
3.Baseline, at postoperative day 1
4.At the end of surgery
|
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
30/05/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study is a randomized, double blinded, placebo controlled trial accessing the effectiveness of calcium gluconate in reducing blood loss in during cesarean section. The main purpose of this study is to whether giving intravenous calcium gluconate will reduce postpartum bleeding in high-risk pregnancy like, twins, previous cesarean section, obese patients, etc. As calcium gluconate is readily available, cheap and economic, using it for the management of postpartum bleeding will be very effective. Similar studies have been done in normal healthy pregnant women and found to show positive results. So, we have extended it the next level, trying to evaluate its effect in high-risk pregnancy. The primary objective of this study is to estimate blood loss and secondary outcomes are to compare preoperative and postoperative ionized calcium levels and hemoglobin level by doing a venous blood gas analysis, accessing the uterine tone and monitoring changes in blood pressures and heart rate. The proposed hypothesis is that intravenous calcium gluconate is effective in reducing blood loss in women posted for cesarean section with risk factor for postpartum hemorrhage. |