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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Treatment Group | Experimental | Patients receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin for labor induction |
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| Retrospective Historical Control Group | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Carbonate | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Total amount of oxytocin after cervical ripening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Forgie, DO | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora Sinai Medical Center | Milwaukee | Wisconsin | 53233 | United States |
Study data will only be shared with those listed on the study team as approved by the internal IRB.
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| ID | Term |
|---|---|
| D004420 | Dystocia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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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.
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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) |
| Gastrointestinal side effects | Participants in the treatment group will describe gastrointestinal side effects. | During the intervention (time on calcium carbonate to delivery) |
| 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 |
| 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 |
| 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 |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |