Administration Of Calcium Gluconate for The Reduction of Blood Loss During Elective Cesarean Delivery

Recruiting now · Not applicable

Conditions studied: Elective Cesarean Delivery

In brief

Postpartum hemorrhage (PPH) is the leading cause of death related to pregnancy. PPH can lead to blood transfusion, disseminated intravascular coagulation (DIC), hysterectomy, or death. The prophylactic administration of uterotonic agents as part of an active management of the third stage of labor has been proven to reduce rates of PPH. However, even with these treatments, PPH rate is still relatively high, and puts women at risk of heavy bleeding and death. Calcium is a key component in the coagulation cascade and known as factor IV. It has a role in platelet activation, and it is an important co-factor for the activation of factors II and There is a concentration-dependent effect of hypocalcemia on in vitro clot strength in patients at risk of bleeding. Calcium gluconate is the calcium salt of gluconic acid, and it has a relatively strong safety profile. Hypocalcemia is a poor prognostic factor in actively bleeding patients. Calcium has a positive inotropic effect both on skeletal muscle and smooth muscle. The inotropic effect doesn't skip the myometrium, and it is well-established that hypocalcemia can impair myometrial contractility. As so, calcium channel blockers are prescribed as a tocolytic drug and calcium gluconate should be considered as adjuvant therapy for treating PPH duo to atony, in case of prolonged tocolytic or magnesium sulfate use prior to delivery. Studies have already shown an association between low ionized calcium levels and the risk for severe bleeding. In a pilot randomized controlled trial of patients with risk factors for uterine atony, calcium was shown to reduce uterine atony compared to placebo. However, current studies have small sample size and are limited to a high-risk population. There are no recommendations in current guidelines for monitoring calcium levels or prescribing calcium as a prophylactic measure for the third stage of labor, despite atony and coagulopathy being significant causes of PPH. HYPOTHESIS: Administration of Calcium Gluconate at the third stage of elective Cesarean delivery will decrease the rates of blood loss during and after the surgery by reducing the rates of uterine atony and development of coagulopathy, thus has the potential of reducing the incidence of PPH and its complications without severe side effects.

Key facts

Study ID

NCT06235749

Run by

Rambam Health Care Campus

People needed

1180

Starts

2023-11-14

Expected to finish

2028-07-31

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Elective Cesarean Delivery, at Gestational age of 35 weeks or more.

You may not qualify if…

• 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 it is running

• Soroka Medical Center — Beersheba, Israel (enrolling)
• Shamir Medical Center — Be’er Ya‘aqov, Israel (enrolling)
• Rambam Medical Center — Haifa, Israel (enrolling)
• Edith Wolfson Medical Center — Holon, Israel (enrolling)

Full record on ClinicalTrials.gov

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