Calcium Carbonate for Labor Induction

Overseen By Emily Malloy, PhD, CNM

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Aurora Health Care

Must be taking: Oxytocin

Disqualifiers: Cesarean, Allergy calcium carbonate, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of induction with oxytocin until delivery

250 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators aim to evaluate the safety and efficacy of administering calcium carbonate to laboring participants undergoing labor inductions. The investigators hypothesize that calcium carbonate is a low-risk preventative measure to decrease oxytocin induction time and dosage, decrease the rate of labor dystocia, decrease the rate of cesarean deliveries, and demonstrate no differences in maternal or neonatal safety outcomes.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have a known contraindication to calcium carbonate, such as certain kidney or calcium-related conditions, you may not be eligible to participate.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Calcium Carbonate for Labor Induction is an effective treatment?

The available research shows that there is no clear evidence supporting the effectiveness of Calcium Carbonate for labor induction. While some clinicians have shared stories of its use for labor issues, the studies mainly discuss its role in muscle contractions and other related areas. However, no direct evidence confirms its success in preventing or treating labor problems. Other treatments, like calcium gluconate and sodium bicarbonate, have been studied more for labor issues, suggesting a need for more research on Calcium Carbonate. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Calcium Carbonate for labor induction?

There is anecdotal evidence from clinicians suggesting that calcium carbonate may help with labor dystocia (difficulty in labor), and some studies indicate that calcium can influence uterine muscle contractions, which might support its potential use in labor induction. ^{1 2 3 4 5}

What safety data exists for using calcium carbonate in labor induction?

Existing safety data for calcium carbonate, often used as an antacid, includes reports of hypercalcemia-induced pancreatitis and calcium-alkali syndrome from excessive intake. These conditions can lead to serious complications such as renal impairment and staghorn calculus formation. Additionally, excessive intake can cause issues during medical procedures, such as colonoscope malfunction. While calcium carbonate is being explored for its potential benefits in labor induction, particularly in preventing labor dystocia, no direct evidence supports its safety or efficacy for this use. Therefore, caution is advised, and further research is needed to establish its safety profile in this context. ^{1 5 6 7 8}

Is calcium carbonate safe for use in humans?

Calcium carbonate is generally safe for humans, but excessive intake can lead to serious issues like hypercalcemia (high calcium levels in the blood), which can cause kidney problems and other complications. It's important to follow recommended dosages and consult with a healthcare provider, especially during pregnancy or when taking other medications. ^{1 5 6 7 8}

Is the drug Calcium Carbonate a promising treatment for labor induction?

The provided research articles do not mention Calcium Carbonate as a treatment for labor induction. Therefore, there is no evidence from these sources to suggest that Calcium Carbonate is a promising drug for this purpose. ^{9 10 11 12 13}

How does the drug Calcium Carbonate differ from other labor induction methods?

Calcium Carbonate is unique for labor induction as it is traditionally used for conditions like heartburn and indigestion, unlike common labor induction drugs such as prostaglandins or oxytocin. This makes its use in labor induction novel, as it is not a standard treatment for this purpose. ^{9 10 11 12 13}

Research Team

Marie Forgie, DO

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for pregnant individuals who are about to undergo labor induction. The specific details on eligibility criteria were not provided, so it's important to consult with the study organizers for more information.

Inclusion Criteria

Singleton gestation

I will receive a standard dose of oxytocin for induction.

I can speak and read in English or Spanish.

Exclusion Criteria

Known need for cesarean section prior to induction of labor

Inability to tolerate oral intake (i.e., nausea/vomiting)

Known allergy to calcium carbonate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive calcium carbonate (500mg every 4 hours) plus standard-dose oxytocin for labor induction

Duration of induction with oxytocin until delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood loss and postpartum hemorrhage

24 hours post-delivery

Neonatal Monitoring

Neonates are monitored for composite adverse outcomes until discharge

3 days

Treatment Details

Interventions

• Calcium Carbonate

Trial Overview The trial is testing if calcium carbonate can help during labor induction by reducing the time and dosage of oxytocin needed, lowering the chances of difficult labor (dystocia), and cutting down cesarean deliveries without harming mother or baby.

Participant Groups

Group I: Prospective Treatment Group Experimental Treatment 1 Intervention

Patients receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin for labor induction

Group II: Retrospective Historical Control Group Active Control 1 Intervention

Patients who presented for induction at the same institution within the previous three years and received standard-dose oxytocin alone for labor induction and were not treated with calcium carbonate

Calcium Carbonate is already approved in United States, European Union for the following indications:

Approved in United States as Calcium Carbonate for:

• Heartburn relief
• Indigestion relief
• Calcium supplement

Approved in European Union as Calcium Carbonate for:

• Heartburn relief
• Indigestion relief
• Calcium supplement

Who Is Running the Clinical Trial?

Aurora Health Care

Lead Sponsor

Trials

46

Recruited

16,400+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

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]

In a trial involving 1106 patients in labor, Andursil was preferred for its taste compared to Magnesium Trisilicate Co, indicating better patient satisfaction.

Despite the preference for Andursil, both treatments had similar rates of nausea and vomiting, suggesting that palatability does not affect the incidence of these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An antacid comparison trial. Atkinson, RE.[2013]

Cimetidine, an H2-receptor antagonist, effectively increased intragastric pH and reduced gastric acidity in parturients, with 80% of patients receiving emergency anesthesia showing a pH higher than 2.5 after treatment.

In a second trial, combining cimetidine with sodium citrate resulted in all elective cesarean section patients having low gastric volumes and pH greater than 2.5, indicating a safe approach to managing gastric contents before anesthesia, with no noted side effects for mothers or infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of cimetidine as an oral antacid in obstetric anesthesia. Johnston, JR., Moore, J., McCaughey, W., et al.[2013]

A 40-year-old woman with eclampsia was found to have severe hypercalcemia due to milk-alkali syndrome from excessive antacid use, highlighting the risks of self-medication with over-the-counter medications.

Treatment involving rehydration and bisphosphonates successfully normalized her calcium levels, and both the mother and her infant had no long-term health issues, demonstrating effective management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Excessive calcium ingestion leading to milk-alkali syndrome. Bailey, CS., Weiner, JJ., Gibby, OM., et al.[2013]

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]

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]

A case study of a woman revealed that long-term use of calcium carbonate antacids (1,800 mg of elemental calcium daily) led to severe hypercalcaemia and kidney damage, highlighting the risks associated with over-the-counter calcium supplements.

The interaction between the calcium carbonate and her prescribed anti-hypertensive medication may have worsened her condition, suggesting that healthcare providers should carefully review patients' medication histories to prevent overlooked cases of calcium-alkali syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons of the month: Over-the-counter antacids causing hypercalcaemia: The emergence of calcium-alkali syndrome. Maarouf, A., Jones, S.[2021]

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 of 852 pregnant women, the use of dinoprostone for labor induction resulted in a successful vaginal delivery in about two-thirds of cases, demonstrating its efficacy in cervical maturation.

The vaginal insert (Propess) showed better outcomes than the intracervical gel (Prepidil) for women with an unfit cervix, while adverse events were rare, occurring in only 1.8% of cases, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacological induction of labour: benefits and risks]. Romanelli, M., Ribiani, E., Burnelli, L., et al.[2013]

The balloon catheter with extra-amniotic saline infusion (BCEAS) was found to be less effective than vaginal prostaglandin E2 (PGE2) for inducing vaginal delivery in a study of 109 pregnant women, particularly among parous women.

While BCEAS resulted in a higher rate of cesarean sections (29% compared to 10% for PGE2), it did not lead to serious infectious complications, and neonatal outcomes were similar for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Induction of labour by balloon catheter with extra-amniotic saline infusion (BCEAS): a randomised comparison with PGE2 vaginal pessaries. Lyndrup, J., Nickelsen, C., Weber, T., et al.[2019]

Natural laxatives such as macrogol and lactulose are recommended as first-line treatments for chronic constipation during pregnancy due to their safety profile and effectiveness, with macrogol offering faster results and fewer side effects.

For second-line treatment, diphenolic laxatives like bisacodyl and sodium picosulfate can be used if first-line treatments are ineffective, but their use should be carefully considered due to potential side effects related to preterm births.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of Chronic Functional Constipation during Pregnancy and Lactation]. Gharehbaghi, K., Gharehbaghi, DR., Wierrani, F., et al.[2016]

In 1993, the induction of labor rate in the U.S. was 134 per 1,000 live births, highlighting its common use for reasons like postdate pregnancy and maternal health issues.

The article reviews various methods for inducing labor, ranging from natural techniques like nipple stimulation to pharmacological options like prostaglandin, emphasizing the importance of cervical ripening in the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods of cervical ripening and labor induction. Summers, L.[2019]

In a randomized controlled trial, breast stimulation was found to significantly increase the likelihood of spontaneous labor, with a 45% incidence compared to the control group.

Breast stimulation also resulted in a meaningful improvement in cervical readiness, as indicated by a mean change of 2.4 points in the Bishop score, suggesting it may be an effective method for preparing the cervix for labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of breast stimulation to ripen the cervix in term pregnancies. Elliott, JP., Flaherty, JF.[2019]

References

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

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

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

An antacid comparison trial. [2013]

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

Use of cimetidine as an oral antacid in obstetric anesthesia. [2013]

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

Excessive calcium ingestion leading to milk-alkali syndrome. [2013]

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

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

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

Excessive Tums Intake Can Cause Colonoscope Malfunction. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Lessons of the month: Over-the-counter antacids causing hypercalcaemia: The emergence of calcium-alkali syndrome. [2021]

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

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

9. Italy pubmed.ncbi.nlm.nih.gov

[Pharmacological induction of labour: benefits and risks]. [2013]

10. Ireland pubmed.ncbi.nlm.nih.gov

Induction of labour by balloon catheter with extra-amniotic saline infusion (BCEAS): a randomised comparison with PGE2 vaginal pessaries. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of Chronic Functional Constipation during Pregnancy and Lactation]. [2016]

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

Methods of cervical ripening and labor induction. [2019]

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

The use of breast stimulation to ripen the cervix in term pregnancies. [2019]