Using Calcium Gluconate to Reduce Blood Loss During Cesarean Delivery
Administration Of Calcium Gluconate for The Reduction of Blood Loss During Elective Cesarean Delivery
This study is testing if Calcium Gluconate can help reduce blood loss during cesarean deliveries for women who have normal calcium levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1180 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Rambam Health Care Campus Academic / other |
| Locations | 4 sites (Beersheba and 3 other locations) |
| Trial ID | NCT06235749 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Calcium Gluconate to reduce postpartum hemorrhage during elective cesarean deliveries. Participants will receive either Calcium Gluconate or a saline solution in addition to Carbetocin, a uterotonic agent, to assess its effectiveness in minimizing blood loss. The study will monitor calcium levels and coagulation profiles before and after surgery to ensure patient safety and evaluate outcomes. Only women with normal calcium levels and no QT interval abnormalities will be included in the trial.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older undergoing elective cesarean delivery at 35 weeks gestation or more.
Not a fit: Patients with calcium channel blocker treatment, chronic renal failure, or any QT abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of postpartum hemorrhage and improve maternal outcomes during cesarean deliveries.
How similar studies have performed: While the use of calcium in managing bleeding is established, this specific application in elective cesarean deliveries is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Elective Cesarean Delivery, at Gestational age of 35 weeks or more. Exclusion Criteria: * Age younger than 18 years old. * Patients treated with calcium channel blockers. * Chronic renal failure and hyperphosphatemia. * Sarcoidosis. * Hypocalcemia (ionized Ca\<1 mmol/L) or hypercalcemia (ionized Ca\> 1.3 mmol/L) before the surgery. * Any QT abnormalities as evident by ECG before Calcium Gluconate administrations or any known conduction abnormality.
Where this trial is running
Beersheba and 3 other locations
- Soroka Medical Center — Beersheba, Israel (Recruiting)
- Shamir Medical Center — Be’er Ya‘aqov, Israel (Recruiting)
- Rambam Medical Center — Haifa, Israel (Recruiting)
- Edith Wolfson Medical Center — Holon, Israel (Recruiting)
Study contacts
- Study coordinator: Gili Buchnik Fater, MD
- Email: gili.buchnik@gmail.com
- Phone: +972-54-6738628
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.