Calcium Carbonate on Labor Induction

Last updated: January 2, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

Calcium Carbonate

Clinical Study ID

NCT06352775
IRB00107112
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult laboring patients ( ≥ 18 years of age)

  • Able to speak and read English or Spanish (for historical cohort, preferred languageshould be English or Spanish)

  • Singleton gestation

  • Greater ≥ 37 weeks gestation in vertex presentation

  • Present for induction of labor inclusive of medical indication, elective indicationat greater than 39 weeks gestation, trial of labor after cesarean

  • Receive standard-dose oxytocin during induction

Exclusion

Exclusion Criteria:

  • Participants will be excluded from the study if they do not meet the above inclusioncriteria or they will be further excluded under the following circumstances:

  • Known need for cesarean section prior to induction of labor

  • Known allergy to calcium carbonate

  • Known contraindication to taking calcium carbonate including renal calculus, highurine calcium levels, elevated serum calcium, low serum phosphate, achlorhydria, orsuspected digoxin toxicity.

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

  • Need to be nothing by mouth (NPO)

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Calcium Carbonate
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin 53233
    United States

    Site Not Available

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