Calcium Supplements for Postpartum Hemorrhage

Overseen By Daniel Conti, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Stanford University

Must not be taking: Digoxin, Calcium channel blockers

Disqualifiers: Severe hypertension, Renal dysfunction, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 10 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of calcium supplements—calcium chloride and calcium gluconate—to determine the optimal dosage for reducing blood loss in women undergoing cesarean deliveries. The researchers aim to identify the right dosage for these calcium forms to ensure consistent and effective treatment, particularly during shortages. The trial specifically targets women scheduled for a C-section at full term (at least 37 weeks pregnant) who are delivering at the study hospital. As an Early Phase 1 trial, this research focuses on understanding how these calcium supplements work in people, offering participants a chance to contribute to groundbreaking medical insights.

Will I have to stop taking my current medications?

If you are taking digoxin or a calcium channel blocker, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both calcium gluconate and calcium chloride are generally safe in medical settings. The FDA has approved calcium gluconate for treating low calcium levels and other conditions, confirming its safety. Additionally, one study found that calcium gluconate during cesarean deliveries might reduce blood loss without serious side effects.

Calcium chloride also has FDA approval for similar uses and is often employed to quickly increase calcium levels in the blood. Although specific studies on side effects were not mentioned, its approval and common use suggest it is safe when used properly.

In early-phase clinical trials, treatments undergo safety testing, so less information is available. However, these treatments have shown enough potential for human testing. While more research is needed, current evidence suggests both calcium gluconate and calcium chloride are safe and well-tolerated in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for postpartum hemorrhage because they utilize calcium chloride and calcium gluconate, which may offer a new approach compared to the usual uterotonics and surgical interventions. Unlike standard treatments, these calcium-based options are administered intravenously right after the umbilical cord is clamped, potentially allowing for rapid intervention. Calcium gluconate and calcium chloride could help stabilize blood clotting factors quickly, offering a potentially faster response to bleeding. This new method could provide a crucial alternative for managing postpartum hemorrhage more effectively and swiftly.

What evidence suggests that calcium supplements could be effective for postpartum hemorrhage?

Research has shown that calcium gluconate, which participants in this trial may receive, can help reduce blood loss during and after a cesarean delivery. One study found it lowered the need for extra medications to control bleeding and decreased overall blood loss. Another study found that using calcium gluconate with another drug reduced excessive bleeding after childbirth and improved recovery. The trial also studies calcium chloride, another type of calcium. While most current research focuses on calcium gluconate, these findings suggest that calcium can be useful in managing blood loss during childbirth. ^{1 2 4 6 7}

Who Is on the Research Team?

Jessica Ansari, MD, MS

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for pregnant women scheduled for a cesarean delivery at term, between the ages of 18 and 45, with a body weight between 55kg and 100kg. They must not have kidney issues (serum Cr >1.0 mg/dL), severe high blood pressure recently, heart disease or arrhythmias, be on certain heart medications like calcium channel blockers or digoxin, nor receive magnesium infusions close to delivery.

Inclusion Criteria

I am pregnant and scheduled for a C-section at the study hospital after 37 weeks.

Exclusion Criteria

My weight is either below 55kg or above 100kg.

I received calcium during surgery as needed.

My kidney function is impaired with a creatinine level over 1.0 mg/dL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either calcium gluconate or calcium chloride intravenously over 10 minutes upon umbilical cord clamping

10 minutes

1 visit (in-person)

Pharmacokinetic Monitoring

Serial lab draws are conducted to gather data for pharmacokinetic analysis at specified intervals after infusion

60 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calcium chloride
• Calcium Gluconate

Trial Overview The study aims to compare two FDA-approved intravenous forms of calcium: Calcium Gluconate and Calcium Chloride in new mothers (parturients). It will determine how each drug is processed in the body and establish the equivalent doses needed for effective treatment during drug shortages.

How Is the Trial Designed?

Group I: Calcium Gluconate Experimental Treatment 1 Intervention

Infused intravenously over 10 minutes upon umbilical cord clamping. First 10 assigned patients received 2 grams per protocol. Subsequent 13 patients received 1.5 grams, dose recalibrated per protocol.

Group II: Calcium Chloride Active Control 1 Intervention

0.5mg calcium chloride, infused intravenously over 10 minute infusion beginning upon umbilical cord clamping

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Oxytocin is the first-line treatment for preventing postpartum hemorrhage, and combining it with second-line uterotonics like methylergonovine or misoprostol can significantly enhance its effectiveness in reducing the risk of hemorrhage.

Tranexamic acid is effective and safe for decreasing maternal mortality associated with postpartum hemorrhage, and its prophylactic use may reduce the need for blood transfusions and additional uterotonics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing postpartum hemorrhage with combined therapy rather than oxytocin alone. Jones, AJ., Federspiel, JJ., Eke, AC.[2023]

Administering 1 g of intravenous tranexamic acid within 1 to 3 hours after delivery significantly reduces maternal mortality due to postpartum hemorrhage (PPH).

This finding is supported by strong evidence from randomized controlled trials and a Cochrane review, indicating that tranexamic acid is an effective intervention when used alongside standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does tranexamic acid reduce mortality in women with postpartum hemorrhage? Dresang, L., Kredit, S., Vellardita, L.[2020]

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/40159712/

Clinical Efficacy of Calcium Gluconate Combined With ... The combination of ergometrine maleate and calcium gluconate effectively reduces PPH, improves stress-related inflammation, and shortens hemostasis time.

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. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/apm.70020

Clinical Efficacy of Calcium Gluconate Combined With ... The study group had significantly lower postpartum blood loss, shorter labor stages, and higher hemoglobin levels and RBC counts at 24 h (p < ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5791179/

Quality medicines in maternal health: results of oxytocin ... In this study, the quality of oxytocin injection, misoprostol tablets, magnesium sulfate, and calcium gluconate injections was assessed across the six ...

7. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(20)30941-7/fulltext

Association between ionised calcium and severity ... Ca 2+ level at the time of diagnosis of PPH was associated with risk of severe bleeding. Ca 2+ monitoring may facilitate identification and treatment of high- ...