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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether calcium carbonate (a common antacid) can make labor induction safer and more effective. Researchers aim to determine if this treatment can reduce the time and amount of oxytocin needed, decrease the likelihood of difficult labor and cesarean deliveries, and ensure safety for both mother and baby. Participants are women at least 37 weeks pregnant with one baby in the correct position for birth, planning to have labor induced. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance labor induction methods.

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 prior data suggests that calcium carbonate is safe for labor induction?

A previous study found calcium carbonate safe for both mothers and newborns, with most experiencing no or only mild side effects. This indicates that calcium carbonate is generally well-tolerated. The study suggested that using calcium carbonate for labor induction could be a low-risk option. It might reduce the need for additional oxytocin (a hormone that helps start labor) and lower the chance of requiring a cesarean delivery. For those considering joining a trial with calcium carbonate, past research indicates it is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using calcium carbonate for labor induction because it introduces a new approach alongside the standard use of oxytocin. Unlike traditional methods that rely solely on oxytocin to stimulate uterine contractions, this treatment combines calcium carbonate with oxytocin, potentially enhancing the effectiveness of labor induction. Calcium carbonate, commonly found in antacids, might help improve uterine responsiveness due to its role in muscle contraction. By exploring this combination, researchers hope to offer a more efficient induction process, potentially reducing the time and stress associated with labor for both mothers and healthcare providers.

What evidence suggests that calcium carbonate could be effective for labor induction?

This trial will evaluate the use of calcium carbonate for labor induction. Research has shown that calcium carbonate might shorten and enhance the effectiveness of labor. One study suggested it could lead to stronger contractions, potentially reducing the time and amount of oxytocin needed to initiate labor. Additionally, there is a theory that it might lower the likelihood of requiring a cesarean section. Although the evidence is still emerging, these early findings indicate that calcium carbonate could be a promising and low-risk option for those undergoing labor induction. Participants in this trial will receive calcium carbonate alongside standard-dose oxytocin, while a retrospective historical control group will be compared, having received only standard-dose oxytocin. ^{1 2 3 4 6}

Who Is on the Research Team?

Marie Forgie, DO

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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. 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 ...

4. thevbaclink.com thevbaclink.com/taking-tums-to-improve-your-chances-of-vbac/

Can Taking TUMS During Labor Help You Get Your VBAC? Taking calcium during labor has been associated with shorter labor times (the idea is that calcium can lead to more efficient contractions during labor).

5. 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 ...

6. pure.aah.org pure.aah.org/en/publications/the-effect-of-calcium-carbonate-on-labor-induction-a-pilot-study

The Effect of Calcium Carbonate on Labor Induction There were no differences in maternal/neonatal safety outcomes. The survey revealed most had no or mild side effects with CaCO3. Conclusion ...