An interventional study of Calcium Gluconate 10% and sodium chloride 0.9% in Elective Cesarean Delivery, sponsored by Rambam Health Care Campus. Recruiting at 4 sites in Israel. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Prevention
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.
After signing a consent form prior to the surgery (at the pre-operative assessment), At the third stage of labor, women who gave their consent to participate in the study will get either 10 ml of Calcium Gluconate 10% solution (containing 0.94 gr of calcium gluconate) diluted in 100 ml of normal saline IV or 110 ml of normal saline IV.
The solutions will be given in addition to Carbetocin (a long acting oxytocin analogue), in both arms. The invastigators will use calcium gluconate during even-numbered months and normal saline during odd-numbered months, or vice versa, according to randomization that will be known to the primary researcher alone.
A blood sample will be drawn at the beginning of the surgery and sent for blood gas analysis, determining ionized calcium levels and coagulation profile. Women with hypocalcemia or hypercalcemia will be excluded from the trial. Only patients with normal calcium levels between 1.0-1.3 mmol/L will be included in this trial.
An ECG strip will be done prior to the surgery, making sure that the patient doesn't suffer from a QT segment abnormality. All patients will be monitored with a 3 lead- ECG prior, during, and 2 hours following calcium administration. Patients with QT interval abnormalities will be excluded from the trial. After the surgery, a blood sample will be drawn and sent to blood gas analysis (determining ionized calcium levels) and for coagulation profile. A complete blood count will be routinely taken for all women the next day. The hemoglobin level will be compared to the hemoglobin level prior to CD.
Decreased mean hemoglobin drop is the primary outcome. the secondary outcomes are described below.
After the primary analysis we will perform a subgroup analysis, determine whether women with high risk for PPH (such as overdistended uterus, abnormal placentation, myomatous uterus, grand multiparty, coagulation disorder, etc.) may benefit from the intervention more than the general population of all participants.
Rambam Health Care Campus is the lead sponsor of 466 studies on the registry; 34 are open to participants now.
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- Elective Cesarean Delivery, at Gestational age of 35 weeks or more.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administration of Calcium Gluconate 10% IV following umbilical cord clamping.
Drug: Calcium Gluconate 10%
Administration of normal saline 0.9% IV following umbilical cord clamping.
Drug: sodium chloride 0.9%
Administration of Calcium Gluconate 10% IV following umbilical cord clamping
Administration of sodium chloride 0.9% IV following umbilical cord clamping
Change in mean hemoglobin drop
Change in mean hemoglobin drop after cesarean delivery at the Calcium gluconate arm, compared to the control arm.
Time frame: 24 hours after the surgery
The rate of women with a decrease of hemoglobin levels of 2 gr/dl or more
The rate of women with a decrease of hemoglobin levels of 2 gr/dl or more.
Time frame: 24 hours after the surgery
additional therapy for the management of PPH
additional therapy for the management of PPH
Time frame: during hospitalization, an average of 4 days
Receipt of blood products.
Receipt of blood products.
Time frame: during hospitalization, an average of 4 days
treatment with intravenous ferrous (iron).
treatment with intravenous ferrous (iron).
Time frame: during hospitalization, an average of 4 days
estimated blood loss during the surgery.
estimated blood loss during the surgery.
Time frame: during the surgery
Hospitalization length of stay.
Hospitalization length of stay.
Time frame: an average of 4 days
Duration of cesarean delivery
Duration of cesarean delivery
Time frame: during the surgery
A composite of adverse maternal outcomes
A composite of adverse maternal outcomes including at least one of the following: admission to intensive care unit (NICU), the need for a surgical treatment for uncontrolled PPH, massive blood transfusion (defined as transfusion of ≥10 units red blood cells (RBCs) in 24 hours, disseminated intravascular coagulation (DIC), and death.
Time frame: during hospitalization, an average of 4 days
Endometritis or antibiotic treatment following CD.
Endometritis or antibiotic treatment following CD.
Time frame: during hospitalization, an average of 4 days
Plan to share: No
Started Nov 2023 (actual). Primary completion is estimated for May 2028, 54 months after the start.
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Studies of the drug tested here: Calcium Gluconate