| CTRI Number |
CTRI/2023/07/055182 [Registered on: 13/07/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to assess the effectiveness of calcium gluconate in prevention of weakness of uterus during lower segmental cesarean section delivery. |
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Scientific Title of Study
|
Efficacy of calcium gluconate in prevention of uterine atony during lower segmental cesarean section delivery: A randomized controlled trial |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOUMYA RANJAN SAHOO |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
AIIMS, New Delhi |
| Address |
ROOM NO. 5O11,5TH FLOOR, ANAESTHESIA OFFICE, DEPARTMENT OF ANAESTHESIOLOGY, PAIN MEDICINE AND CRITICAL CARE, AIIMS NEW DELHI
South DELHI 110029 India |
| Phone |
|
| Fax |
|
| Email |
soumyasahoo199806@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
RAKESH KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO. 5O07,5TH FLOOR, ANAESTHESIA OFFICE, DEPARTMENT OF ANAESTHESIOLOGY, PAIN MEDICINE AND CRITICAL CARE, AIIMS NEW DELHI
South DELHI 110029 India |
| Phone |
|
| Fax |
|
| Email |
drrakesh.kumar.akb@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
RAKESH KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS NEW DELHI |
| Address |
ROOM NO. 5O07,5TH FLOOR, ANAESTHESIA OFFICE, DEPARTMENT OF ANAESTHESIOLOGY, PAIN MEDICINE AND CRITICAL CARE, AIIMS NEW DELHI
South DELHI 110029 India |
| Phone |
|
| Fax |
|
| Email |
drrakesh.kumar.akb@gmail.com |
|
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Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY, PAIN MEDICINE AND CRITICAL CARE, AIIMS NEW DELHI, ANSARI NAGAR, 110029 |
|
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Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, PAIN MEDICINE AND CRITICAL CARE, AIIMS New Delhi, ANSARI NAGAR, New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SOUMYA RANJAN SAHOO |
AIIMS New Delhi |
AB8, DEPARTMENT OF ANAESTHESIOLOGY, PAIN MEDICINE AND CRITICAL CARE, AIIMS NEW DELHI South DELHI |
9668363058
soumyasahoo199806@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, All India Institute of Medical Sciences |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O721||Other immediate postpartum hemorrhage, (2) ICD-10 Condition: O721||Other immediate postpartum hemorrhage, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INFUSION OF CALCIUM GLUCONATE |
After umbilical cord is clamped, institutional standard regimen of oxytocin bolus is to be followed. At the same time, an infusion of 100ml study solution(calcium gluconate 3grams) is given intravenously to patient over 10 minutes. Uterine tone adequacy is formally assessed by attending obstetrician at 3, 6 and 10 minutes after delivery. If the uterine tone was found inadequate at 3 and 6 minutes, further oxytocin boluses of 3U each will be given to the patient intravenously at those time points. If at 10 minute, tone is still found inadequate, a second line uterotonic agent intramuscular Carboprost 250mcg will be given which is repeated every 15 minutes, till a maximum of 8 times to a maximum dose of 2mg. If patient has previous h/o asthma, such patients will receive rectal Misoprostol 800mcg or buccal Misoprostol 600mcg as decided by the operating obstetrician or attending anaesthesiologist. Continuous monitoring of oxygen saturation, heart rate and NIBP measurements will be taken every 3 minutes during infusion of study solution. The infusion will be discontinued if any adverse events like hemodynamic disturbances, arrhythmia, extravasation, intravenous line discomfort, severe nausea or vomiting occurs and will be noted. Patients who complain of nausea/ vomiting will receive Ondansetron 4mg as antiemetic. Postoperatively, patients will be managed in the postoperative care unit where standard monitoring of oxygen saturation (SpO2), heart rate (HR) and non invasive blood pressure monitoring will be done every 15 minutes till 1 hour followed by one hour interval till PACU stay then one hour interval in ward till first 24 hours. All patients will receive moist oxygen through face mask to maintain SpO2 more than 96. Venous blood gas analysis will be done before surgery and 1hr after calcium infusion to look for serum ionized calcium levels.
|
| Comparator Agent |
INFUSION OF NORMAL SALINE AS PLACEBO |
After umbilical cord is clamped, institutional standard regimen of oxytocin bolus is to be followed. At the same time, an infusion of 100ml study solution(normal saline) is given intravenously to patient over 10 minutes. Uterine tone adequacy is formally assessed by attending obstetrician at 3, 6 and 10 minutes after delivery. If the uterine tone was found inadequate at 3 and 6 minutes, further oxytocin boluses of 3U each will be given to the patient intravenously at those time points. If at 10 minute, tone is still found inadequate, a second line uterotonic agent intramuscular Carboprost 250mcg will be given which is repeated every 15 minutes, till a maximum of 8 times to a maximum dose of 2mg. If patient has previous h/o asthma, such patients will receive rectal Misoprostol 800mcg or buccal Misoprostol 600mcg as decided by the operating obstetrician or attending anaesthesiologist. Continuous monitoring of oxygen saturation, heart rate and NIBP measurements will be taken every 3 minutes during infusion of study solution. The infusion will be discontinued if any adverse events like hemodynamic disturbances, arrhythmia, extravasation, intravenous line discomfort, severe nausea or vomiting occurs and will be noted. Patients who complain of nausea/ vomiting will receive Ondansetron 4mg as antiemetic. Postoperatively, patients will be managed in the postoperative care unit where standard monitoring of oxygen saturation (SpO2), heart rate (HR) and non invasive blood pressure monitoring will be done every 15 minutes till 1 hour followed by one hour interval till PACU stay then one hour interval in ward till first 24 hours. All patients will receive moist oxygen through face mask to maintain SpO2 more than 96%. Venous blood gas analysis will be done before surgery and 1hr after calcium infusion to look for serum ionized calcium levels.
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1)Pregnant female patients (18 to 45 years of age)
2)ASA physical class II or III
3)Emergency or elective LSCS with risk factors of PPH
4)Patients who have atleast two of the following established risk factors for uterine atony: intrapartum Cesarean delivery, failed operative vaginal delivery with forceps or vacuum, magnesium infusion, Chorioamnionitis, multiple gestation, Polyhydramnios, preterm delivery <37 weeks, prior history of postpartum hemorrhage, labor induction or augmentation with oxytocin, advanced maternal age, obesity with body mass index >40.
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| ExclusionCriteria |
| Details |
1)Patient refusal to participate in the study
2)Maternal history of cardiac disease, arrhythmias, CAD
3)History of renal dysfunction with serum creatinine>1.0 mg/dL
4)Patients with placenta accreta
5)Treatment with digoxin within the last 2 weeks for a maternal or fetal indication
6)Treatment with a calcium channel blocker within 24 hours
7)General anaesthesia
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome variable of the study is the incidence of uterine atony and hence PPH in cesarean section (PPH is defined by a blood loss more than 1000ml, need for a second line uterotonic or any additional mechanical/surgical measures by surgeon to stop bleeding like bimanual compression, uterine packing, balloon tamponade, B lynch sutures, Cho sutures, Hayman sutures, uterine artery ligation or embolization or hysterectomy). |
0 to 24 hours |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| The study intends to compare the amount of intraoperative blood loss, requirement of intravenous fluids and blood products if PPH occur in a case. The study also aims to compare intraoperative hemodynamic parameters between the two groups. Total units of oxytocin boluses and other uterotonics used in 24 hours will also be recorded. Uterine tone will be assessed by numerical rating score(0-100) at 3, 6, and 10 minutes after fetal delivery and the absolute 10 minute score as well as relative from 10-3 and 10-6 minute scores will also be analysed. |
0 to 24 hours |
|
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Target Sample Size
|
Total Sample Size="146" Sample Size from India="146"
Final Enrollment numbers achieved (Total)= "146"
Final Enrollment numbers achieved (India)="146" |
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Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/07/2023 |
| Date of Study Completion (India) |
26/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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) |
Completed |
Publication Details
Modification(s)
|
not yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Postpartum hemorrhage (PPH) is one of the most common causes of maternal mortality worldwide including India. Uterine atony accounts for 90% of cases of postpartum hemorrhage. Postpartum hemorrhage is a dreaded third stage complication arising most commonly from uterine atony but less frequently from coagulopathy, genital tract trauma or retained placental tissues. Prevention of PPH includes general measures like correction of pre-existing anemia, routine use of partogram which helps to avoid prolonged labour, active management of third stage of labour (AMTSL), routine inspection for retained products of placenta or any genital tract trauma, prophylactic oxytocin bolus or infusion before delivery of placenta to promote uterine contractions and to improve tone. Management of PPH is by medical, mechanical and surgical methods. Medical management includes resuscitation with intravenous fluids blood and blood products and use of uterotonic (oxytocin, carboprost, methylergometrine, misoprostol). Mechanical methods include uterine massage, manual compression of uterus, intrauterine tamponade (Bakri balloon, condom catheter). Surgical measures include application of sutures in uterus (B-Lynch, Hayman sutures), uterine artery ligation and emergency hysterectomy. Routinely oxytocin is used as a prophylaxis and second line uterotonics (Carboprost, Methylergometrine, Misoprostol) are used as treatment for PPH. But second line uterotonics have significant limitation in form of cost and other associated medical conditions limiting their use. So, there is a need to search second line drugs which can be used as a preventive or treatment modality for PPH. Calcium plays an important role in uterine contractility in physiological conditions. A number of in vitro studies have established that myometrial contractility is dependent upon extracellular calcium levels. In the setting of low or absent extracellular calcium, amplitude of myometrial contraction diminishes and oxytocin’s efficacy in inducing myometrial contraction diminishes by 60-75%. Low serum concentration of calcium affects normal uterine contractility during normal labor and PPH. Jessica R et al, in a pilot study demonstrated that one gram of calcium chloride is significantly effective in prevention of uterine atony without any significant adverse effects of hypercalcemia. So, we hypothesize that supraphysiologic effect of calcium by administration of calcium gluconate in equivalent dose of one gram of calcium chloride is effective in prevention of uterine atony in Indian population and hence will reduce incidence of postpartum haemorrhage and need for blood transfusion without any adverse effect of significant hypercalcemia. |