[Epidemiology of post-partum haemorrhage].
C Deneux-Tharaux, M-P Bonnet, J Tort
https://pubmed.ncbi.nlm.nih.gov/25447386Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06235749
Administration of Calcium Gluconate to Reduce Blood Loss During Elective Cesarean Delivery
Led by Rambam Health Care Campus · Updated on 2025-01-28
1180
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Postpartum hemorrhage (PPH) is a leading cause of death related to pregnancy, potentially causing blood transfusion, clotting disorders, hysterectomy, or death. This research evaluates whether giving calcium gluconate during the third stage of elective cesarean delivery can reduce blood loss by lowering uterine atony and coagulopathy rates. Calcium is important for blood clotting and muscle contraction, and low calcium levels are linked to severe bleeding and poor uterine muscle function. Participants will receive either 10 ml of 10% calcium gluconate diluted in saline or a saline placebo intravenously after umbilical cord clamping, both alongside a standard drug called Carbetocin. The study uses a double-blind, randomized design where the calcium or placebo is given according to a schedule known only to the primary researcher. Blood and heart tests will be done before and after surgery to monitor calcium levels, blood clotting, and heart function, while patients are continuously monitored for safety. Women in the study will have blood samples taken for calcium and coagulation analysis before and after surgery, along with routine blood counts the day after. Researchers will measure the change in hemoglobin levels 24 hours after surgery as the main outcome. Other evaluations include blood loss during surgery, need for additional treatments or blood products, length of hospital stay, surgery duration, and any adverse maternal outcomes. The total hospital stay is about four days, during which close monitoring will occur to assess safety and effectiveness.
CONDITIONS
Brief Title
Administration Of Calcium Gluconate for The Reduction of Blood Loss During Elective Cesarean Delivery
Who Can Participate
Age: 18Years +
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Elective cesarean delivery at gestational age of 35 weeks or more
You will not qualify if you...
- Age younger than 18 years old
- Use of calcium channel blockers
- Chronic renal failure and hyperphosphatemia
- Diagnosis of sarcoidosis
- Hypocalcemia (ionized calcium <1 mmol/L) or hypercalcemia (ionized calcium >1.3 mmol/L) before surgery
- Any QT abnormalities or known heart conduction problems on ECG before calcium administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) prior to surgery for blood tests and ECG
Treatment
Duration - During the surgery and 2 hours post-administration
Participants receive an IV infusion of either Calcium Gluconate 10% solution or normal saline following umbilical cord clamping during elective cesarean delivery, in addition to Carbetocin. Monitoring with ECG occurs before, during, and for 2 hours after administration.
1 hospitalization visit including surgery and monitoring
Follow-up
Duration - Up to 4 days post-surgery during hospitalization
Participants have blood samples drawn after surgery and a complete blood count taken the next day to assess hemoglobin levels and coagulation profile. Additional monitoring for adverse outcomes occurs during hospitalization.
Daily assessments during hospitalization (average 4 days)
Trial Site Locations
Total: 4 locations
1
Soroka Medical Center
Beersheba, Israel
Actively Recruiting
2
Shamir Medical Center
Be’er Ya‘aqov, Israel
Actively Recruiting
3
Rambam Medical Center
Haifa, Israel, 3525408
Actively Recruiting
4
Edith Wolfson Medical Center
Holon, Israel
Actively Recruiting
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Research Team
G
Gili Buchnik Fater, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Overview of the coagulation system.
Sanjeev Palta, Richa Saroa, Anshu Palta
https://pubmed.ncbi.nlm.nih.gov/25535411Concentration-dependent effect of hypocalcaemia on in vitro clot strength in patients at risk of bleeding: a retrospective cohort study.
K M Ho, C B Yip
https://pubmed.ncbi.nlm.nih.gov/26729371Calcium levels during the initiation of labor.
Lampros Papandreou, Georgios Chasiotis, Konstantinos Seferiadis...
https://pubmed.ncbi.nlm.nih.gov/15223159Hypocalcemia is associated with adverse clinical course in patients with upper gastrointestinal bleeding.
Alexander Korytny, Amir Klein, Erez Marcusohn...
https://pubmed.ncbi.nlm.nih.gov/33651325Association Between Ionized Calcium Level and Neurological Outcome in Endovascularly Treated Patients with Spontaneous Subarachnoid Hemorrhage: A Retrospective Cohort Study.
Danny Epstein, Yaacov Freund, Erez Marcusohn...
https://pubmed.ncbi.nlm.nih.gov/33829378Effects of external calcium, magnesium, and temperature on spontaneous contractions of pregnant human myometrium.
T Kawarabayashi, T Kishikawa, H Sugimori
https://pubmed.ncbi.nlm.nih.gov/2765618Association between ionised calcium and severity of postpartum haemorrhage: a retrospective cohort study.
Danny Epstein, Neta Solomon, Alexander Korytny...
https://pubmed.ncbi.nlm.nih.gov/33341222Calcium chloride for the prevention of uterine atony during cesarean delivery: A pilot randomized controlled trial and pharmacokinetic study.
Jessica R Ansari, Neil Kalariya, Brendan Carvalho...
https://pubmed.ncbi.nlm.nih.gov/35447502