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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how blood calcium levels change after taking a common calcium tablet. This information will help researchers determine if calcium can reduce heavy bleeding after childbirth, a serious condition. Participants will take a single dose of oral calcium carbonate (such as Tums) to study its effects. Pregnant women admitted for labor who haven't recently taken calcium supplements might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking insights.

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.

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

Research has shown that taking calcium carbonate orally, as found in Tums, is generally safe. However, it can temporarily raise calcium levels in the blood, which some children on dialysis have experienced. In adults, calcium carbonate is commonly used and usually well-tolerated. This trial is in an early stage, so the treatment's safety is still under careful study. Prospective participants can feel reassured that early studies have not identified any major safety issues with this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using oral calcium carbonate for postpartum hemorrhage because it offers a simple, non-invasive approach to managing this condition. Unlike current treatments, which often involve intravenous medications or surgical interventions, this treatment is administered orally, making it more accessible and potentially easier to use, especially in low-resource settings. Additionally, calcium plays a crucial role in blood clotting, and providing it in an oral form could help stabilize patients quickly without the need for complex medical equipment. This simplicity and accessibility could revolutionize care for postpartum hemorrhage, particularly in areas where advanced medical resources are limited.

What evidence suggests that oral calcium carbonate might be an effective treatment for postpartum hemorrhage?

Research has shown that oral calcium carbonate can raise blood calcium levels. This is important because calcium aids muscle contractions, including those in the uterus. Improved contractions may help reduce heavy bleeding after childbirth, known as postpartum hemorrhage. Although the direct effects on postpartum hemorrhage are still under investigation in this trial, calcium has shown benefits in related conditions like preeclampsia when combined with low-dose aspirin. This suggests that calcium might help manage bleeding during labor. ^{1 2 3 5 6}

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 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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06650930

Pharmacokinetics of Oral Calcium Carbonate in Parturients This information is important for trials investigating whether calcium can reduce postpartum hemorrhage, bleeding after delivery.

2. withpower.com withpower.com/trial/early-phase-1-postpartum-hemorrhage-2025-6b224

Oral Calcium 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10358971/

Calcium Carbonate as a Potential Intervention to Prevent ... No results from evaluating the effect of calcium carbonate during labor were found.

4. journals.lww.com journals.lww.com/md-journal/fulltext/2023/08250/clinical_efficacy_of_low_dose_aspirin_combined.32.aspx

Clinical efficacy of low-dose aspirin combined with calcium ... Low-dose aspirin combined with calcium supplementation was more effective in preventing preeclampsia, reduced the risk of preterm birth and postpartum ...

5. ctv.veeva.com ctv.veeva.com/study/oral-calcium-supplementation-in-labor

Oral Calcium Supplementation in Labor - ClinicalTrials.Veeva The goal of this clinical trial is to learn if oral calcium carbonate can improve uterine contractions and labor outcomes in term ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07056062?term=TREATMENt

NCT07056062 | Oral Calcium Supplementation in Labor The goal of this clinical trial is to learn if oral calcium carbonate can improve uterine contractions and labor outcomes in term pregnancies.