Calcium Gluconate for Reducing Blood Loss in Cesarean Delivery

Overseen By Hero Eisley

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Michigan

Must not be taking: Digoxin, Calcium channel blockers

Disqualifiers: Renal disease, Cardiac condition, Hypercalcemia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a single dose of calcium gluconate, a mineral supplement, can reduce blood loss during cesarean deliveries for those at high risk of uterine atony, a condition where the uterus doesn't contract properly after childbirth. Participants will receive either calcium gluconate or a placebo to assess any significant differences in outcomes. Suitable candidates have a viable pregnancy of at least 24 weeks and face a high risk of heavy bleeding during a cesarean, such as those with more than four prior deliveries or multifetal pregnancies. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important medical advancements.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you cannot take calcium channel blockers, certain antihypertensive medications, or drugs that can cause high calcium levels, like Vitamin D or thiazide diuretics, close to the screening period.

Is there any evidence suggesting that calcium gluconate is likely to be safe for humans?

Research has shown that calcium gluconate is usually safe for people. In past studies, patients who took calcium gluconate did not report any major side effects. For instance, a study on intravenous calcium chloride, similar to calcium gluconate, also found it safe for participants. Although these studies focus on related substances, they suggest that calcium gluconate might be safe for the body.

Since this trial is in its early stages, detailed safety information about using calcium gluconate during cesarean delivery is still being gathered. The fact that it is being tested now suggests confidence in its safety based on earlier research and clinical experience. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for reducing blood loss during cesarean deliveries, which often involve medications to contract the uterus or surgical techniques, calcium gluconate offers a unique approach by potentially strengthening blood vessels and improving blood clotting. This treatment is derived from calcium, a vital mineral already known for its role in bone health and muscle function, making it a familiar and potentially safer option. Researchers are excited about calcium gluconate because it could provide a more straightforward and possibly quicker way to reduce blood loss without the side effects associated with other medications.

What evidence suggests that calcium gluconate might be an effective treatment for reducing blood loss in cesarean delivery?

This trial will compare the effects of calcium gluconate and a placebo in reducing blood loss during cesarean deliveries. Studies have shown that calcium gluconate can help reduce blood loss in these procedures. Previous research associated taking 1 gram of calcium gluconate with less blood loss and a reduced need for additional medications to control bleeding. However, it did not increase uterine firmness, which can be important in such situations. While these findings are promising for reducing blood loss, the treatment's effect on overall uterine firmness remains unclear. ^{1 2 6 7 8}

Who Is on the Research Team?

AnneMarie Opipari, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for pregnant patients at high risk for uterine atony, which can lead to excessive blood loss during cesarean delivery. Specific eligibility criteria are not provided, but typically include those who are of legal age to consent and have a medical diagnosis that puts them at high risk.

Inclusion Criteria

English speaking

Scheduled Cesarean Delivery at High Risk for Atonic Bleeding Defined as scheduled Cesarean-Section (CS) plus any one of: > 4 Prior deliveries, General anesthesia, Multifetal gestation, Polyhydramnios diagnosed by ultrasound within 2 weeks, Macrosomia ≥ 4000gms; estimated fetal weight by palpation or by ultrasound, Fibroid uterus, defined as: Multiple ≥ 2cm intramural, Any history of prior Primary postpartum hemorrhage (PPH), Platelets < 100,000 (but >50,000), Placenta Previa, Body Mass Index (BMI) ≥ 40

I am currently pregnant and have passed 24 weeks of pregnancy.

Exclusion Criteria

Non-English speaking

Antenatal suspicion for placenta accreta spectrum

History of allergic reaction to Calcium Gluconate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of calcium gluconate or placebo at the time of cesarean delivery

Immediate

1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for blood loss and other outcomes immediately following surgery

4 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including transfusion requirements and additional hemostasis procedures

48 hours

What Are the Treatments Tested in This Trial?

Interventions

• Calcium Gluconate

Trial Overview The study is testing the effect of a single dose of calcium gluconate compared to saline (a placebo) on reducing blood loss in patients undergoing cesarean delivery who are at high risk for uterine atony.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 Intervention

Randomized to receive intervention

Group II: Arm 2 Placebo Group 1 Intervention

Randomized to receive placebo

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959289X25002961

Effect of prophylactic intravenous calcium gluconate on ... Prophylactic calcium gluconate 1 g reduced blood loss and second-line uterotonic use, but did not improve uterine tone. Abstract. Background. Nearly two-thirds ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40493979/

Effect of prophylactic intravenous calcium gluconate on ... Conclusion: Intravenous calcium gluconate (1 g) did not improve uterine tone, evaluated by the obstetricians with a numeric rating score, during intrapartum ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06235749

Administration Of Calcium Gluconate for The Reduction ... HYPOTHESIS: Administration of Calcium Gluconate at the third stage of elective Cesarean delivery will decrease the rates of blood loss during and after the ...

4. obstetanesthesia.com obstetanesthesia.com/article/S0959-289X(25)00296-1/abstract

Effect of prophylactic intravenous calcium gluconate on ... Prophylactic calcium gluconate 1 g reduced blood loss and second-line uterotonic use, but did not improve uterine tone.

5. ajogmfm.org ajogmfm.org/article/S2589-9333(25)00048-5/fulltext

Letter to the editor regarding 'role of prophylactic ... While the findings demonstrate efficacy in mitigating hypotension and reducing postpartum blood loss, we believe that several key aspects merit ...

6. trialx.com trialx.com/clinical-trials/listings/325439/prophylactic-intravenous-calcium-gluconate-to-decrease-blood-loss-at-time-of-cesarean-delivery-in-pregnant-patients-at-high-risk-for-uterine-atony/

Prophylactic Intravenous Calcium Gluconate to Decrease ... This research study is being done to learn what effect a single dose of calcium gluconate will have on blood loss at the time of cesarean ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818022001532

Calcium chloride for the prevention of uterine atony during ... Intravenous calcium chloride was well-tolerated by the 20 patients assigned to receive the study drug and may be effective in prevention of uterine atony.

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT06235749/Prot_000.pdf

Administration Of Calcium Gluconate for The Reduction of ... Outcome measures. Primary outcome : 1. Decreased mean hemoglobin drop after cesarean delivery at the Calcium gluconate arm, compared to the ...