| 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
|
|
|
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
|
|
|
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. |