Calcium Carbonate for Labor Augmentation

(CALC Trial)

Recruiting at 1 trial 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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether calcium carbonate can enhance contractions during labor when used with Pitocin, a common labor-inducing medicine. Researchers aim to determine if this combination makes labor more effective. The trial includes two groups: one receives only Pitocin, while the other receives both calcium carbonate and Pitocin. Women over 36 weeks pregnant, having their first baby, and planning to use Pitocin during labor might be suitable candidates. As a Phase 4 trial, this research seeks to understand how the already FDA-approved treatment benefits more patients, providing valuable insights for potential participants.

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 is the safety track record for calcium carbonate?

Research has shown that calcium carbonate is generally safe to use during labor. Studies suggest it might aid contractions when combined with oxytocin, a common drug for inducing labor. Calcium carbonate is also present in products like antacids, which are safe for most people.

In past studies, participants tolerated calcium carbonate well, and no serious side effects occurred when used with oxytocin. This suggests it could be a low-risk option for assisting with labor. However, individual responses vary, so discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using calcium carbonate for labor augmentation because it offers a novel approach to enhancing labor progression. Unlike the standard use of synthetic oxytocin (Pitocin) alone, this treatment combines calcium carbonate, a common dietary supplement, with Pitocin. This combination could potentially enhance the effectiveness of oxytocin, potentially leading to a more efficient labor process. The unique aspect here is the addition of calcium carbonate, which might work synergistically with oxytocin to improve contractions, offering a promising alternative to the current standard of care.

What evidence suggests that this trial's treatments could be effective for labor augmentation?

This trial will compare the use of calcium carbonate with Pitocin to Pitocin alone for labor augmentation. Research has shown that calcium carbonate might improve labor contractions when combined with Pitocin. Some studies suggest it could reduce the need for higher doses of oxytocin, the active ingredient in Pitocin, and might lower the likelihood of a cesarean section. Calcium carbonate may enhance muscle function during labor, leading to more successful vaginal deliveries. While these findings are promising, further research is ongoing to confirm these results. ^{1 2 4 6 7}

Who Is on the Research Team?

Moeun Son, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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)

Singleton gestation (a multiple gestation reduced to a singleton, either spontaneously or therapeutically, before 14 0/7 weeks of gestation is acceptable)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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]

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]

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]

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]

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]

Citations

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

Calcium Carbonate as a Potential Intervention to Prevent ... We theorize that calcium carbonate may be a low-risk and promising preventive measure that may decrease the rate of cesarean section.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06352775?term=Carbonate%20ion&rank=6

NCT06352775 | Calcium Carbonate on Labor Induction The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06580782?term=Carbonate%20ion&rank=7

Calcium Carbonate to Augment Labor Contractions The study aims to find if the use of calcium carbonate will lead to better labor contractions and increase the percentage of vaginal deliveries and improve ...

4. trialx.com trialx.com/clinical-trials/listings/319573/calcium-carbonate-to-augment-labor-contractions/

Calcium Carbonate to Augment Labor Contractions This study plans to study the acceptance and safety of using calcium carbonate as an medicine to help the labor induction process. The study ...

5. ctv.veeva.com ctv.veeva.com/study/calcium-carbonate-on-labor-induction

Calcium Carbonate on Labor Induction - ClinicalTrials.Veeva The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor

6. institutionalrepository.aah.org institutionalrepository.aah.org/cgi/viewcontent.cgi?article=1463&context=sciday

The Effect of Calcium Carbonate on Labor Induction We conducted a pilot study to inform sample size for larger studies and to explore the use of CaCO3 to augment labor induction by assessing (1) induction ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06352775

NCT06352775 | Calcium Carbonate on Labor Induction The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of ...