Calcium Carbonate for Labor Augmentation

(CALC Trial)

Recruiting in New York City (>99 mi)

+1 other location

Overseen By Ester Sanchez, BSN

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must be taking: Oxytocin

Must not be taking: Calcium channel blockers, Magnesium

Disqualifiers: Tachysystole, Non-vertex fetus, Multi-fetal, others

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

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 5 days

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators think that calcium carbonate can act as an assistive medication to improve contractions during labor.

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 calcium channel blockers like nifedipine or magnesium.

What data supports the effectiveness of the drug calcium carbonate for labor augmentation?

There is anecdotal evidence from clinicians suggesting that calcium carbonate may help with labor dystocia (difficult labor), and studies on similar compounds like calcium gluconate indicate potential benefits for uterine muscle contractions. However, no direct evidence currently supports its effectiveness for labor augmentation. ^{1 2 3 4 5}

Is calcium carbonate safe for use in humans?

Calcium carbonate is generally safe for most people when taken in recommended doses, but excessive intake can lead to serious issues like hypercalcemia (high calcium levels in the blood), kidney problems, and milk-alkali syndrome, especially in those with existing kidney issues or who take certain medications. It's important to follow dosage guidelines and consult a healthcare provider if you have any underlying health conditions. ^{1 5 6 7 8}

How does calcium carbonate differ from other treatments for labor augmentation?

Calcium carbonate is unique for labor augmentation as it is a simple and low-cost option that may help improve uterine muscle contractility, potentially reducing the need for cesarean sections. Unlike other treatments, it is traditionally used for conditions like GERD and renal issues, but its role in labor is still being explored. ^{1 2 5 9 10}

Research Team

Moeun Son, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for first-time pregnant women (nulliparas) aged 18 or older, who are at least 36 weeks into their pregnancy and need help starting or strengthening labor. It's open to those with a single baby in the womb and includes those planning a vaginal birth after cesarean. Participants must be able to consent.

Inclusion Criteria

I am over 36 weeks pregnant.

Nulliparas (no prior pregnancy lasting 20 weeks or greater of gestation)

I am 18 years old or older.

Exclusion Criteria

I cannot eat or drink without feeling sick.

I have chronic kidney disease with high phosphate levels.

I am currently taking calcium channel blockers like nifedipine or magnesium.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either standard-dose synthetic oxytocin (Pitocin) alone or in combination with oral calcium carbonate for labor induction or augmentation

Approximately 5 days

During hospitalization

Follow-up

Participants are monitored for delivery outcomes and neonatal health indicators such as APGAR scores and cord blood gases

Approximately 5 days

During hospitalization

Treatment Details

Interventions

• Calcium Carbonate

Trial Overview The study tests if calcium carbonate can make labor contractions more effective when used alongside standard treatments. Women will be randomly assigned to receive either calcium carbonate or no additional treatment during labor induction.

Participant Groups

Group I: Calcium Carbonate with Pitocin Experimental Treatment 2 Interventions

Participants will start an oral calcium carbonate regimen at the same time as initiating synthetic oxytocin (Pitocin) infusion.

Group II: Pitocin Active Control 1 Intervention

Control group will receive only the standard-dose synthetic oxytocin (Pitocin) alone for labor induction or augmentation.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

A case study of a pregnant woman revealed that excessive consumption of calcium carbonate for GERD led to hypercalcemia and pancreatitis, highlighting a serious complication of this common treatment.

The patient's condition improved after delivery and appropriate medical management, indicating that while calcium carbonate can be effective for GERD, it must be used cautiously to avoid potential adverse effects during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypercalcemia-Induced Pancreatitis in Pregnancy Following Calcium Carbonate Ingestion. Trezevant, MS., Winton, JC., Holmes, AK.[2022]

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]

Chewing calcium carbonate (CaCO3) significantly improved esophageal motor function in heartburn sufferers, as evidenced by increased proximal esophageal contractile amplitude and enhanced acid clearance after ingestion.

The study, involving 18 participants, suggests that the calcium released from chewed antacids may help reduce heartburn by improving peristalsis initiation and acid clearance, independent of its acid-neutralizing properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium carbonate antacids alter esophageal motility in heartburn sufferers. Rodriguez-Stanley, S., Ahmed, T., Zubaidi, S., et al.[2019]

In a study involving 68 high-risk pregnant women, both cimetidine and magnesium trisilicate were found to be safe antacid therapies, as there were no significant differences in health outcomes for their infants.

While both treatments resulted in similar complication rates for infants, those whose mothers received magnesium trisilicate required oxygen therapy for a longer duration, suggesting a potential difference in neonatal care needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cimetidine in labour: absence of adverse effect on the high-risk fetus. McAuley, DM., Halliday, HL., Johnston, JR., et al.[2019]

Calcium supplementation is important for preventing and treating conditions like osteoporosis and hypertension, especially in North America where dietary intake is often low.

Chelated calcium and refined calcium carbonate supplements are generally safe and effective for most people, but it's crucial not to exceed 2,000 mg of calcium without medical advice due to potential risks like mineral deficiencies and milk-alkali syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium supplementation. Whiting, SJ., Wood, R., Kim, K.[2023]

A patient experienced complications during an EGD and colonoscopy due to excessive calcium carbonate from daily Tums use, which coated the stomach and proximal colon, leading to equipment clogging.

After discontinuing Tums, a repeat colonoscopy showed complete resolution, highlighting the importance of monitoring calcium carbonate intake to prevent similar issues and reduce healthcare costs associated with repeat procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excessive Tums Intake Can Cause Colonoscope Malfunction. Anderson, J., Harris, C., Deutch, A.[2020]

Milk-alkali syndrome can occur even in individuals who do not consume large amounts of milk, as demonstrated by a case of a young woman who developed acute renal failure after ingesting excessive calcium carbonate from antacids and yogurt.

Early recognition of hypercalcemia and alkalosis, along with stopping calcium carbonate intake, is crucial for recovery; nephrologists should advise patients with renal insufficiency and chronic vomiting to avoid calcium-rich antacids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rolaids-yogurt syndrome: a 1990s version of milk-alkali syndrome. Muldowney, WP., Mazbar, SA.[2023]

Milk-Alkali syndrome, characterized by hypercalcemia, metabolic alkalosis, and renal impairment, can occur due to excessive use of over-the-counter calcium antacids like Tums®, highlighting the need for awareness of this condition.

The management of Milk-Alkali syndrome involves early diagnosis, discontinuation of calcium supplements, and intravenous hydration, which are crucial for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No more milk in milk-alkali syndrome: a case report. Almusawi, A., Alhawaj, S., Al-Mousawi, M., et al.[2021]

In a study involving seven patients, two alternative calcium carbonate preparations (Calcium-500 and Calcichew) were found to be effective phosphate binders at a significantly lower dosage compared to the commonly prescribed Titralac, which requires up to 12 tablets daily.

Both alternative preparations did not cause significant changes in serum calcium and phosphate levels, suggesting they are safe options that can improve patient compliance and reduce treatment costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium carbonate 1250 mg/1260 mg: an effective phosphate binder. Taylor, JE., Henderson, IS., Stewart, WK., et al.[2017]

The disintegration test is crucial for assessing the availability of calcium from calcium carbonate tablets, indicating how well the tablets dissolve in the stomach.

Different manufacturers' tablets showed varying disintegration behaviors, which affected calcium availability and phosphorus binding, suggesting that not all calcium carbonate tablets are equally effective for treating renal osteodystrophy in uremic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological testing of calcium carbonate tablets for use in the treatment of renal osteodystrophy. Dal Zotto, M., Ragazzi, E., Realdon, N., et al.[2016]

References

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

Hypercalcemia-Induced Pancreatitis in Pregnancy Following Calcium Carbonate Ingestion. [2022]

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

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

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

Calcium carbonate antacids alter esophageal motility in heartburn sufferers. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Cimetidine in labour: absence of adverse effect on the high-risk fetus. [2019]

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

Calcium supplementation. [2023]

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

Excessive Tums Intake Can Cause Colonoscope Malfunction. [2020]

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

Rolaids-yogurt syndrome: a 1990s version of milk-alkali syndrome. [2023]

8. Oman pubmed.ncbi.nlm.nih.gov

No more milk in milk-alkali syndrome: a case report. [2021]

9. Scotland pubmed.ncbi.nlm.nih.gov

Calcium carbonate 1250 mg/1260 mg: an effective phosphate binder. [2017]

10. France pubmed.ncbi.nlm.nih.gov

Technological testing of calcium carbonate tablets for use in the treatment of renal osteodystrophy. [2016]