Calcium Carbonate on Labor Induction

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352775
• Other study ID #: IRB00107112
• Status: Recruiting
• Phase: Phase 1
• Start date: June 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Aurora Health Care
• Contact: Jessica Kram, MPH
• Phone: 414-219-5594
• Email: jessica.kram[@]aah.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Participants will be excluded from the study if they do not meet the above inclusion

criteria 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, 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)

Related Conditions & MeSH terms

• Pregnancy
• Uterine Contraction

Intervention

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.

Locations

Country	Name	City	State
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Rate of cesarean deliveries	Participants in the treatment group will have a lower rate of cesarean deliveries than those in the retrospective historical control group.	During the intervention (measured from time of induction to delivery)
Secondary	Total amount of oxytocin after cervical ripening	Participants in the treatment group will receive a lower amount of oxytocin than those in the retrospective historical control group.	During the intervention (time on oxytocin after cervical ripening completed to delivery)
Secondary	Gastrointestinal side effects	Participants in the treatment group will describe gastrointestinal side effects.	During the intervention (time on calcium carbonate to delivery)
Secondary	Blood loss	Participants in the treatment group will experience less blood loss than those in the retrospective historical control group.	Time from delivery to 24 hours of birth
Secondary	Rate of postpartum hemorrhage (>/= 500mL)	Participants in the treatment group will experience less postpartum hemorrhage than those in the retrospective historical control group.	Time from delivery to 24 hours of birth
Secondary	Neonatal composite adverse outcomes	Neonates of participants in the treatment group will have comparable composite adverse outcomes to those born to participants in the retrospective historical control group.	Immediately after the birth until the time of discharge, an average of 3 days