Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352775
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-03-07
Brief Title:
Calcium Carbonate on Labor Induction
Sponsor:
Aurora Health Care
Organization:
Aurora Health Care
Study Overview
Official Title:
The Effect of Calcium Carbonate on Labor Induction A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dystociafailed induction 3 rate of cesarean section and 4 maternalneonatal 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None