Pregnancy, Uterine Contraction
Conditions
Keywords
Pregnancy, Uterine contraction, Calcium carbonate, Labor induction time, Labor dystocia
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.
Interventions
DIETARY_SUPPLEMENTCalcium 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.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal side effects | During the intervention (time on calcium carbonate to delivery) | Participants in the treatment group will describe gastrointestinal side effects. |
| 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 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed