Oral Calcium for Postpartum Hemorrhage

Overseen By Jordan Abrams, 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: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study investigates the time course of change in calcium in the blood after a pregnant subject takes an oral dose of calcium carbonate (commonly marketed as "Tums"). This information is important for trials investigating whether calcium can reduce postpartum hemorrhage, bleeding after delivery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking digoxin or a calcium channel blocker.

What data supports the effectiveness of the drug oral calcium carbonate for postpartum hemorrhage?

Research shows that oral calcium carbonate can effectively increase calcium levels in the blood, which may help in conditions where calcium plays a role in blood clotting. Additionally, it has been used successfully in other medical conditions to manage calcium levels, suggesting potential benefits in managing postpartum hemorrhage. ^{1 2 3 4 5}

Is oral calcium carbonate safe for humans?

Oral calcium carbonate is generally safe for humans, but it can cause temporary high calcium levels in the blood, as seen in children on dialysis. In adults, it is well-tolerated with few side effects, though it can increase blood calcium levels. ^{6 7 8 9 10}

How does the drug oral calcium carbonate differ from other treatments for postpartum hemorrhage?

Oral calcium carbonate is unique because it is administered orally, which is less invasive than other treatments for postpartum hemorrhage that may require injections or surgical interventions. Additionally, it is commonly used to manage calcium levels in other conditions, suggesting it may help stabilize calcium levels during postpartum hemorrhage. ^{2 3 5 11 12}

Research Team

Jessica Ansari, MD, MS

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for pregnant women aged 18-45, admitted for labor or cesarean delivery without cardiac disease, arrhythmia, severe blood pressure issues, renal dysfunction, or on certain medications like calcium channel blockers and digoxin. They should weigh between 55kg and 100kg.

Inclusion Criteria

I am pregnant and admitted to the hospital for delivery.

Exclusion Criteria

I have a history of heart disease or irregular heartbeats.

I am currently taking medication for my blood pressure.

I will receive a magnesium infusion before or during my cesarean delivery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take a single dose of oral calcium carbonate 3000mg

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in ionized calcium concentration over 4 hours

4 hours

1 visit (in-person)

Treatment Details

Interventions

• Oral Calcium Carbonate

Trial Overview The study examines how the level of calcium in the blood changes after taking oral calcium carbonate (Tums) during pregnancy. The goal is to see if it can help reduce bleeding after childbirth.

Participant Groups

Group I: Oral calcium carbonate Experimental Treatment 1 Intervention

Patients take a single dose of oral calcium carbonate 3000mg

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Calcium carbonate may be a simple and low-cost option for addressing labor dystocia, although no direct evidence was found to support its effectiveness in preventing this condition.

The review highlights the physiological role of calcium in enhancing uterine muscle contractility and suggests that further research, including randomized control trials, is needed to evaluate calcium carbonate's potential benefits in labor management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium Carbonate as a Potential Intervention to Prevent Labor Dystocia: Narrative Review of the Literature. Raees, S., Forgie, M., Mitchell, R., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Acute changes in serum calcium and parathyroid hormone circulating levels induced by the oral intake of five currently available calcium salts in healthy male volunteers. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Uraemic gangrene syndrome: is parathyroidectomy always necessary? [2019]

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

Elucidating the effect of specific surface area on the gastrointestinal absorption of nanostructured calcium through Calcium-45 in vivo radiotracing. [2021]

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

Efficacy and Safety of Sucroferric Oxyhydroxide and Calcium Carbonate in Hemodialysis Patients. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Oral pulse therapy with vitamin D3 for control of secondary hyperparathyroidism. [2019]

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

The Efficacy of Calcium Carbonate-Vitamin D3 in Pregnant Women for the Prevention of Hypertensive Disorders in Pregnancy. [2023]

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

Calcium Carbonate as a Potential Intervention to Prevent Labor Dystocia: Narrative Review of the Literature. [2023]

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

Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Delivery: A Randomized Controlled Trial. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Calcium acetate versus calcium carbonate as phosphate binders in hemodialysis patients. [2018]

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

Effects of oral calcium carbonate on control of serum phosphorus and changes in plasma aluminum levels after discontinuation of aluminum-containing gels in children receiving dialysis. [2019]

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

Comparative absorption of calcium from carbonate tablets, lactogluconate/carbonate effervescent tablet, and chloride solution. [2019]

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

Long-term CaCO3 treatment of chronic hemodialysis patients: an attempt to prevent aluminum osteopathy. [2016]