Clinical trial NCT06352775: Calcium Carbonate on Labor Induction
Official title: The Effect of Calcium Carbonate on Labor Induction: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy
Uterine Contraction
Keywords: Pregnancy
Uterine contraction
Calcium carbonate
Labor induction time
Labor dystocia
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Duration of induction time
timeFrame: During the intervention (time from duration of induction with oxytocin start to delivery)
measure: Rate of labor dystocia
timeFrame: During the intervention (measured from time of induction to delivery)
Secondary outcomes:
measure: Rate of cesarean deliveries
timeFrame: During the intervention (measured from time of induction to delivery)
measure: Total amount of oxytocin after cervical ripening
timeFrame: During the intervention (time on oxytocin after cervical ripening completed to delivery)
measure: Gastrointestinal side effects
timeFrame: During the intervention (time on calcium carbonate to delivery)
measure: Blood loss
timeFrame: Time from delivery to 24 hours of birth
measure: Rate of postpartum hemorrhage (>/= 500mL)
timeFrame: Time from delivery to 24 hours of birth
measure: Neonatal composite adverse outcomes
timeFrame: Immediately after the birth until the time of discharge, an average of 3 days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Marie Forgie, DO
role: PRINCIPAL_INVESTIGATOR
References: