Calcium Carbonate on Labor Induction

Wake Forest University (WFU)

Status: Active, not recruiting

Conditions: Uterine Contraction; Pregnancy

Treatments: Dietary Supplement: Calcium Carbonate

Study type: Interventional

Funder types: Other

Identifiers

NCT06352775

IRB00107112

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Prospective Treatment Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Calcium Carbonate

Retrospective Historical Control Group

No Intervention group

Description:

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