Calcium Carbonate on Labor Induction

Not Applicable

Active, not recruiting

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.

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.

Recruitment & 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)

Arm && Interventions

Group	Intervention	Description
Prospective Treatment Group	Calcium Carbonate	Patients receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin for labor induction

Primary Outcome Measures

Name	Time	Method
Duration of induction time	During the intervention (time from duration of induction with oxytocin start to delivery)	Participants in the treatment group will have a shorter duration of induction with oxytocin than those in the retrospective historical control group.
Rate of labor dystocia	During the intervention (measured from time of induction to delivery)	Participants in the treatment group will have a lower rate of labor dystocia than those in the retrospective historical control group.

Secondary Outcome Measures

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

Locations (1): Aurora Sinai Medical Center
🇺🇸
Milwaukee, Wisconsin, United States