Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06235749

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

Led by Rambam Health Care Campus · Updated on 2025-01-28

1180

Participants Needed

4

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Elective Cesarean Delivery at gestational age of 35 weeks or more
Not Eligible

You will not qualify if you...

  • Age younger than 18 years old
  • Treatment with calcium channel blockers
  • Chronic renal failure and hyperphosphatemia
  • Sarcoidosis
  • Hypocalcemia (ionized calcium <1 mmol/L) or hypercalcemia (ionized calcium >1.3 mmol/L) before surgery
  • Any QT abnormalities or known conduction abnormalities on ECG before Calcium Gluconate administration

AI-Screening

AI-Powered Screening

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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

CONTACT

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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