| CTRI Number |
CTRI/2025/02/080641 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
IV Calcium Gluconate for prevention of PPH during cesarean delivery: Randomised placebo control trial |
|
Scientific Title of Study
|
Injection Calcium Gluconate for prevention of post partum haemorrhage during cesarean delivery: Randomised placebo control 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 |
Dr Merlyn Joseph |
| Designation |
Post graduate |
| Affiliation |
Shri BM Patil Medical College and Research centre |
| Address |
Shri BM Patil Medical College and Research centre, Solapur road, Bangaramma Sajjan Campus, Vijaypura, Karnataka - 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
7904176024 |
| Fax |
|
| Email |
joseph.merlyn09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelamma Patil |
| Designation |
Professor |
| Affiliation |
Shri BM Patil Medical College and Research centre |
| Address |
Department of obstetrics and gynaecology, first floor, Shri BM Patil Medical College and Research centre, Solapur road, Bangaramma Sajjan Campus, Vijaypura, Karnataka - 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9845068074 |
| Fax |
|
| Email |
neelamma.patil@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Merlyn Joseph |
| Designation |
Post graduate |
| Affiliation |
Shri BM Patil Medical College and Research centre |
| Address |
Department of obstetrics and gynecology, first floor, Shri BM Patil Medical College and Research centre, Solapur road, Bangaramma Sajjan Campus, Vijaypura, Karnataka - 586103
Bijapur
KARNATAKA
586103
India |
| Phone |
7904176024 |
| Fax |
|
| Email |
joseph.merlyn09@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Merlyn Joseph |
| Address |
Shri BM Patil Medical College, Solapur Road, Bangaramma Sajjan Campus, Vijayapura, Karnataka - 586103 |
| 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 Merlyn Joseph |
Shri BM Patil Medical college and research centre |
Department of obstetrics and gynaecology, first floor ,Shri BM Patil Medical college, Solapur Road, Bangaramma Sajjan campus, Vijayapura, Karnataka - 586103
Bijapur
KARNATAKA |
7904176024
joseph.merlyn09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri BM Patil Medical College, hospital and research centre, Institute ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pregnant women undergoing cesarean section |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Calcium gluconate |
Inj Calcium Gluconate 10mg in 100ml NS intravenous infusion over 10 mins after skin incision |
| Comparator Agent |
Inj Oxytocin + 100ml NS |
100ml NS given after skin incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primigravida or multigravida with period of gestation ≥ 37 weeks undergoing caesarean section with singleton pregnancy with vertex presentation
|
|
| ExclusionCriteria |
| Details |
all patients with high risk for pph
polyhydramnios
antepartum hemorrhage
preeclampsia
grand multipara
prolonged labor
preterm
previous myomectomy
history of drug allergy to calcium gluconate
history of medical disorders like cardiac, liver, renal disorders
intrauterine fetal demise
cardiac arrhythmia |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the efficacy, side effects of IV Calcium Gluconate for prevention of PPH during caesarean section and to observe for the intraoperative blood loss |
To know the efficacy, side effects of IV Calcium Gluconate for prevention of PPH during caesarean section and to observe for the intraoperative blood loss at 3 mins, 6 mins and 10 mins after administration of the drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for second line of oxytocic
Side effect of Calcium Gluconate
To know Calcium levels in emergency LSCS
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
Final Enrollment numbers achieved (Total)= "176"
Final Enrollment numbers achieved (India)="176" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2025 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 - Anyone
- 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 [Joseph.merlyn09@gmail.com].
- For how long will this data be available start date provided 24-06-2024 and end date provided 24-06-2029?
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 can be a traumatic experience for individuals. Postpartum haemorrhage (PPH) is the most common cause of maternal mortality worldwide. It is classically defined as excessive loss of blood with a threshold of 500 ml or more after vaginal delivery or 1000 ml or more after a caesarean section. PPH can happen suddenly and requires prompt medical intervention.The primary cause of PPH is often attributed to uterine atony, which is delineated as inability of the uterus to properly contract after placental delivery. Therefore it is a necessity to avoid uterine atony during caesarean delivery which indeed serves as a crucial step to avoid post partum haemorrhage. Currently for the prophylaxis of PPH we give Oxytocin, Carbetocin and use of second line uterotonics, including Carboprost, Misoprost etc. |