Effect of Oral Calcium Carbonate on Uterine Contractility and Labor Outcomes: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Contraction Frequency
研究概览
简要总结
The goal of this clinical trial is to learn if oral calcium carbonate can improve uterine contractions and labor outcomes in term pregnancies. It will also evaluate the safety of calcium carbonate when used during labor. The main questions it aims to answer are:
Does oral calcium carbonate increase uterine contraction strength? Does it lead to shorter labor duration or higher vaginal delivery rates? What side effects or complications, if any, occur with calcium carbonate use during labor?
Researchers will compare oral calcium carbonate to no treatment to see if it helps improve labor efficiency and reduce cesarean delivery rates.
Participants will:
Be randomly assigned to receive either 2,000 mg of oral calcium carbonate or no intervention Undergo monitoring with an intrauterine pressure catheter to measure contraction strength Be observed for two hours without oxytocin to assess calcium's direct effect on contractions Have data collected on labor progression, delivery outcomes, and neonatal health
详细描述
In the United States, nearly one-third of deliveries are performed via cesarean section, with labor dystocia remaining a leading indication. Labor dystocia may result from a variety of maternal and fetal factors, including malposition, cephalopelvic disproportion, or ineffective uterine contractions. When contractions are inadequate, the standard intervention is intravenous oxytocin. However, prolonged or high-dose oxytocin administration can lead to receptor desensitization, reducing its effectiveness and increasing the risk of postpartum hemorrhage.
Calcium plays a key role in myometrial contractility by facilitating calcium influx through L-type channels in myometrial cells, which triggers intracellular calcium release and action potentials. During labor, upregulation of calcium channels enhances the uterus's responsiveness to contractile stimuli. Elevated serum calcium levels have been associated with stronger and more effective contractions.
Adjunctive intravenous calcium administration with oxytocin has been shown to improve labor outcomes, including higher rates of vaginal delivery within 24 hours of induction and reduce blood loss in cesarean deliveries. However, the potential role of oral calcium supplementation in enhancing labor progression has not been evaluated in clinical trials. Given its physiological relevance, accessibility, and low-risk profile, oral calcium may represent a simple adjunct to improve labor efficiency and reduce cesarean rates.
This study aims to evaluate the impact of oral calcium carbonate supplementation during labor on uterine contractility and clinical outcomes. The investigators hypothesize that calcium carbonate administered intrapartum will enhance uterine contractions, resulting in higher vaginal delivery rates, shorter time to delivery, and reduced blood loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Had an intrauterine pressure catheter in place
- •Term gestation, greater than or equal to 37 weeks of gestation
- •Singleton pregnancy
- •Cephalic presentation
- •> 18 years of age
排除标准
- •incarceration
- •multiple gestation
- •active illicit drug use
- •abnormal clinical pelvimetry
- •Suspected fetal macrosomia defined as estimated fetal weight ≥4250 grams
- •intrauterine growth restriction
- •abnormal placentation
- •prior cesarean delivery
- •maternal history of arrhythmia
- •hyperparathyroidism
- •heart failure
- •renal or hepatic failure
- •nephrolithiasis
- •receipt of medications known to affect uterine contractility-such as magnesium sulfate, terbutaline, or recent misoprostol in the last four hours
研究组 & 干预措施
Calcium carbonate
2,000 mg PO calcium carbonate as a single dose
干预措施: Calcium carbonate (Drug)
结局指标
主要结局
Contraction Frequency
时间窗: Two hours after receiving the study medication or, for control participants, two hours after enrollment.
Recording the number of contractions in a ten-minute period for 2 hours
Uterine contraction strength
时间窗: Two hours after receiving the study medication or, for control participants, two hours after enrollment.
Recording Montevideo units every 30 minutes for 2 hours
Peak strength
时间窗: Two hours after receiving the study medication or, for control participants, two hours after enrollment.
Recording the max pressure generated during a contraction using an intrauterine pressure catheter during the 2-hour study period
次要结局
- Mode of delivery(Calculated at the time of delivery)
- Duration of the first stage of labor(Calculated at the time of delivery)
- Duration of the second stage of labor(Calculated at the time of delivery)
- Pitocin dose(Calculated at the time of delivery)
- Neonatal outcomes(at the time of discharge (assessed up to 5 days))
- Postpartum hemorrhage(at the time of discharge (assessed up to 5 days))
研究者
Tina Bui
MFM Fellow
Arrowhead Regional Medical Center