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CTRI Number  CTRI/2024/10/074578 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Calcium gluconate in preventing post partum blood as loss as intervention in hypertensive women 
Scientific Title of Study   Effect of prophylactic intravenous calcium gluconate compared to placebo on postpartum blood loss in women with hypertensive disorders of pregnancy at term gestation undergoing emergency caesarean delivery: A randomised, double-blinded, placebo-controlled. 
Trial Acronym  nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Supriya R 
Designation  Junior resident  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Women and Child Health, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar Pondicherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9597451417  
Fax    
Email  JR7846@jipmer.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Nivedita 
Designation  Associate professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Women and Child Health, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar Pondicherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9487581663  
Fax    
Email  dr.niveditajha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Supriya R 
Designation  Junior resident  
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Women and Child Health, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar Pondicherry 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9597451417  
Fax    
Email  jr7846@jipmer.ac.in  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Institute of postgraduate medical education and research, Dhanvantri nagar, Pondicherry - 605006 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER, Dhanvantri nagar, Pondicherry - 605006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Supriya R  Jawaharlal Institute of Postgraduate Medical Education and Research  Women and Child Health, Department of Obstetrics and Gynaecology, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Pondicherry - 605006
Pondicherry
PONDICHERRY 
9597451417

supriya07raj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Intervention studies JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O169||Unspecified maternal hypertension,unspecified trimester,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo - normal saline infusion   Women will receive 100ml normal saline infusion as a placebo over 10 mins 
Intervention  Prophylactic intravenous calcium gluconate infusion   Women will receive 1g (10ml) of calcium gluconate in 90 ml of normal saline as infusion over 10mins. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Women with hypertensive disorders of pregnancy aged 18 – 45 years at or beyond 37 weeks of gestation undergoing emergency cesarean delivery.  
 
ExclusionCriteria 
Details  1. Renal dysfunction with serum Creatinine > 1.0 mg/dl
2.Known history of maternal cardiac disease, including arrhythmia, ischemic, and congenital cardiac disease
3. Treatment with digoxin within the last 2 weeks
4. Pre-existing bleeding disorders/ established DIC
5. Patient with pulmonary edema
6. Patients with chronic hypertension and chronic hypertension with superimposed preeclampsia.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of prophylactic intravenous calcium gluconate compared to placebo on postpartum blood loss in women with hypertensive disorders of pregnancy at term geastation undergoing emergency caesarean delivery.
 
Intraoperative blood loss at the end of surgery and upto 2 hours post delivery
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study the efficacy of prophylactic intravenous calcium gluconate compared to normal saline infusion on :
1.Incidence of PPH
2.Maternal hemodynamic status
3.Uterine tone
4.Need for additional uterotonic agents (methylergometrine/ prostaglandins F2alfa/E1)
5.Need for blood transfusions
6.Need for inotropic requirement
7.Need for other surgical interventions for management of PPH
2. To study the effect of prophylactic intravenous calcium gluconate infusions on maternal hemoglobin pre and post intervention.
 
2 HOURS POST PARTUM 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   12/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/10/2024 
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 - NO
Brief Summary  
Post-partum hemorrhage (PPH) is the leading preventable cause of maternal mortality and morbidity. WHO in its Postpartum Haemorrhage Summit – 2023 declared that each year about 14 million women experience PPH resulting in about 70,000 maternal deaths globally. Even in cases where women survive, there is frequently a requirement for immediate surgical interventions to manage the bleeding, potentially resulting in long-term reproductive challenges1. Hypertensive Disorders of Pregnancy (HDP) is another spectrum of disorders resulting in significant maternal mortality and morbidity, complicating 5% to 10% of all pregnancies. Women with HDP are reported to have an increased risk of postpartum haemorrhage2. In that spectrum, women with pre-eclampsia are more prone to postpartum hemorrhage, with an increased risk of 1.53 times relative to other disorders.3 Though uterine atonicity, trauma (lacerations or uterine rupture), retained placenta or clots, and clotting-factor deficiency are found to be the significant causes for postpartum haemorrhage, uterine atonicity tops the list, accounting for approximately 70% of cases.4 The prophylactic administration of uterotonic agents as part of active management of the third stage of labour has been proven to reduce rates of PPH. Despite the availability of interventions, the rate of PPH is still relatively high, which poses a significant risk to women who may experience heavy bleeding postpartum, which may even lead to death.5 
Rationale: Understanding the role of coagulation in postpartum haemostasis and uterine contraction is crucial. Ionised calcium plays an essential role as a coagulation cofactor. Recent studies have shown that low calcium levels are independently associated with postpartum blood loss6. Preeclampsia typically presents with haemorrhagic complications owing to its strong correlation with angiogenic factors.   Calcium is postulated to have a positive inotropic effect on uterine smooth muscle. It functions as an essential co-factor for the activation of factors II and X. Hence, calcium gluconate, a readily available safer intravenous form of calcium salt, can be used as a prophylactic measure to reduce blood loss in the third stage of labour7.
 
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