Pregnancy Clinical Trial
Official title:
The Effect of Calcium Carbonate on Labor Induction: A Pilot Study
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Aurora Sinai Medical Center | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Aurora Health Care |
United States,
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 |
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