NCT06352775

Calcium Carbonate on Labor Induction

The Effect of Calcium Carbonate on Labor Induction: A Pilot Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The investigators plan to assess (1) duration of induction with oxytocin administration, (2) rate of labor dystocia/failed induction, (3) rate of cesarean section, and (4) maternal/neonatal safety. Currently, calcium carbonate is used by clinicians in patients with varying characteristics, at varying doses, and at various times in their labor process based on their professional preference and experience. The investigators will implement a standardized treatment protocol for calcium carbonate use within a defined patient population who voluntarily agree to prospectively receive the intervention and then analyze predetermined safety and efficacy outcomes in comparison to a historical cohort of patients meeting the criteria for the defined patient population who did not have any documented calcium carbonate use during labor.

Conditions

• Pregnancy
• Uterine Contraction

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Calcium Carbonate	We will be using it in routes and doses consistent with its approved uses. Per the drug label information for Calcium Carbonate USP 500 mg found in the US National Library of Medicine, adults may take 2-4 tablets as symptoms occur and if pregnant to not exceed 10 tablets in 24 hours. Therefore, using a dosing of 500mg every 4 hours will be well below that guidance. When both cervical ripening has been completed and the oxytocin administration begins, the calcium carbonate treatment group will be given calcium carbonate 500mg every 4 hours (not to exceed 10 tablets in 24 hours) until they deliver.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-04-08
• Last updated: 2025-11-21

Locations

1 site across 1 country: United States