Calcium Carbonate on Labor Induction

NCT06352775 | Active Not Recruiting

• 1 other identifier: IRB00107112
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Uterine Contraction

Keywords

Pregnancy; Uterine contraction; Calcium carbonate; Labor induction time; Labor dystocia

Outcome Measures

Primary Outcomes (2)

• Duration of induction time

  Participants in the treatment group will have a shorter duration of induction with oxytocin than those in the retrospective historical control group.

  During the intervention (time from duration of induction with oxytocin start to delivery)

• Rate of labor dystocia

  Participants in the treatment group will have a lower rate of labor dystocia than those in the retrospective historical control group.

  During the intervention (measured from time of induction to delivery)

Secondary Outcomes (6)

• Rate of cesarean deliveries

  During the intervention (measured from time of induction to delivery)

• Total amount of oxytocin after cervical ripening

  During the intervention (time on oxytocin after cervical ripening completed to delivery)

• Gastrointestinal side effects

  During the intervention (time on calcium carbonate to delivery)

• Blood loss

  Time from delivery to 24 hours of birth

• Rate of postpartum hemorrhage (>/= 500mL)

  Time from delivery to 24 hours of birth

Study Arms (2)

Prospective Treatment Group

EXPERIMENTAL

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

Dietary Supplement: Calcium Carbonate

Retrospective Historical Control Group

NO 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

Interventions

Calcium Carbonate DIETARY_SUPPLEMENT

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.

Prospective Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult laboring patients ( ≥ 18 years of age)
• Able to speak and read English or Spanish (for historical cohort, preferred language should be English or Spanish)
• Singleton gestation
• Greater ≥ 37 weeks gestation in vertex presentation
• Present for induction of labor inclusive of medical indication, elective indication at greater than 39 weeks gestation, trial of labor after cesarean
• Receive standard-dose oxytocin during induction

You may not qualify if:

• Known need for cesarean section prior to induction of labor
• Known allergy to calcium carbonate
• Known contraindication to taking calcium carbonate including renal calculus, high urine calcium levels, elevated serum calcium, low serum phosphate, achlorhydria, or suspected digoxin toxicity.
• Inability to tolerate oral intake (i.e., nausea/vomiting)
• Need to be nothing by mouth (NPO)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Dystocia

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Marie Forgie, DO

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The quasi-experimental design will include a prospective treatment group and retrospective historical control group. The prospective treatment group will identify 50 patients who will be voluntarily consented and receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin. This group will be compared against a retrospective historical control group of 200 randomly selected patients (1:4 ratio) who presented for induction at the same institution within the previous three years and received standard-dose oxytocin alone.

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: April 8, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)