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

34 Participants Needed

Trial Summary

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 it safe to use calcium supplements like calcium chloride and calcium gluconate in humans?

Calcium chloride and calcium gluconate are generally safe for use in humans, with a low incidence of mild to moderate infusion site reactions when given intravenously. These reactions are rare and may include phlebitis (vein inflammation) or infiltration (fluid leakage into surrounding tissue). ^{1 2 3 4 5}

How does the drug Calcium Supplements for Postpartum Hemorrhage differ from other treatments?

Calcium supplements like Calcium chloride and Calcium Gluconate are unique in treating postpartum hemorrhage as they focus on optimizing clotting potential, which is different from the standard uterotonic drugs like oxytocin that primarily work by contracting the uterus to stop bleeding. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial aims to determine the appropriate doses of two types of calcium for women giving birth, especially those having a surgical delivery. Calcium is crucial for many medical conditions and may help reduce blood loss during delivery. The study will help doctors choose the right dose and manage drug shortages better.

Research Team

Jessica Ansari, MD, MS

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Choice of calcium salt. A comparison of the effects of calcium chloride and gluconate on plasma ionized calcium. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Safety of compounded calcium chloride admixtures for peripheral intravenous administration in the setting of a calcium gluconate shortage. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Y-site simulation compatibility study of 10% calcium salts with various injectable solutions during toxicological resuscitation. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of calcium chloride in increasing blood calcium concentrations of periparturient dairy cows. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Comparative effects of calcium chloride and calcium gluceptate. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Preventing postpartum hemorrhage with combined therapy rather than oxytocin alone. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

[Postpartum hemorrhage--an update]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Preventing postpartum hemorrhage: managing the third stage of labor. [2006]

9. France pubmed.ncbi.nlm.nih.gov

[Initial management of primary postpartum hemorrhage]. [2006]

10. United States pubmed.ncbi.nlm.nih.gov

Does tranexamic acid reduce mortality in women with postpartum hemorrhage? [2020]