The Effect of Calcium Carbonate on Labor Induction: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Duration of induction time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Retrospective Historical Control Group
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
Prospective Treatment Group
Patients receive calcium carbonate (500mg every 4 hours, per standardized treatment protocol) plus standard-dose oxytocin for labor induction
干预措施: Calcium Carbonate (Dietary Supplement)
结局指标
主要结局
Duration of induction time
时间窗: 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
时间窗: 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.
次要结局
- Blood loss(Time from delivery to 24 hours of birth)
- Rate of postpartum hemorrhage (>/= 500mL)(Time from delivery to 24 hours of birth)
- Gastrointestinal side effects(During the intervention (time on calcium carbonate to delivery))
- Rate of cesarean deliveries(During the intervention (measured from time of induction to delivery))
- Neonatal composite adverse outcomes(Immediately after the birth until the time of discharge, an average of 3 days)
- Total amount of oxytocin after cervical ripening(During the intervention (time on oxytocin after cervical ripening completed to delivery))