Administration of Calcium Gluconate for the Reduction of Blood Loss During Vaginal Delivery: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 710
- 试验地点
- 1
- 主要终点
- Proportion of Participants With a Hemoglobin Decrease of ≥2 g/dL
研究概览
简要总结
Postpartum hemorrhage is one of the leading causes of maternal morbidity following childbirth. Even when excessive bleeding is not clinically recognized, some women experience a significant decrease in hemoglobin levels after delivery, which may result in anemia, fatigue, delayed recovery, and the need for additional medical treatment.
Calcium plays an important role in uterine muscle contraction and blood clotting. Previous studies have suggested that calcium administration may help reduce blood loss after childbirth. However, there is limited evidence regarding its effectiveness during vaginal delivery.
The purpose of this study is to evaluate whether administration of intravenous calcium gluconate immediately after umbilical cord clamping can reduce postpartum blood loss following vaginal delivery.
Participants will be randomly assigned to receive either calcium gluconate or a placebo solution immediately after umbilical cord clamping during vaginal delivery. Neither the participants nor their healthcare providers will know which treatment was administered. Blood tests routinely obtained during hospitalization after delivery will be used to assess changes in hemoglobin levels and other outcomes related to postpartum bleeding.
The results of this study may help determine whether calcium gluconate is a safe and effective intervention for reducing postpartum blood loss after vaginal delivery.
详细描述
Postpartum hemorrhage (PPH) remains a major cause of maternal morbidity worldwide. In addition to clinically recognized PPH, a substantial proportion of women experience significant postpartum hemoglobin decline without overt signs of excessive bleeding. Such blood loss may contribute to postpartum anemia, fatigue, delayed recovery, and increased healthcare utilization.
Calcium plays a critical role in both uterine muscle contraction and the coagulation cascade. Transient reductions in serum calcium concentrations have been observed during labor and immediately after delivery. It has been hypothesized that calcium supplementation during the third stage of labor may enhance uterine contractility and reduce postpartum blood loss.
The objective of this randomized, double-blind, placebo-controlled trial is to evaluate whether intravenous calcium gluconate administered immediately after umbilical cord clamping reduces postpartum blood loss following vaginal delivery.
Eligible participants will be randomized in a 1:1 ratio to receive either 10 mL of 10% calcium gluconate diluted in 100 mL of normal saline or 110 mL of normal saline placebo administered intravenously immediately after umbilical cord clamping. Participants, healthcare providers, and outcome assessors will remain blinded to treatment allocation.
The co-primary outcomes are: (1) the proportion of participants experiencing a hemoglobin decrease of at least 2 g/dL from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization, and (2) the mean change in hemoglobin level from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Gestational age of 37 weeks or more, and planning a vaginal delivery.
排除标准
- •Age younger than 18 years old.
- •Patients treated with calcium channel blockers
- •Patients with Preeclampsia with severe features receiving magnesium sulfate infusion.
- •Chronic renal failure and hyperphosphatemia
- •Patients with known Para-Thyroid disease
- •Sarcoidosis
结局指标
主要结局
Proportion of Participants With a Hemoglobin Decrease of ≥2 g/dL
时间窗: From pre-delivery baseline to 24-48 hours postpartum. If additional Hb measurements are obtained later during hospitalization and demonstrate a further decline, the lowest hemoglobin value recorded during the hospitalization will be used for analysis.
Proportion of participants with a decrease of at least 2 g/dL in hemoglobin concentration from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization. Hemoglobin levels will be routinely measured 24-48 hours after vaginal delivery; if additional hemoglobin measurements are obtained later during hospitalization, the lowest recorded value will be used for analysis.
Mean Change in Hemoglobin Level
时间窗: From pre-delivery baseline to 24-48 hours postpartum. If additional Hb measurements are obtained later during hospitalization and demonstrate a further decline, the lowest hemoglobin value recorded during the hospitalization will be used for analysis.
Proportion of participants with a decrease of at least 2 g/dL in hemoglobin concentration from the pre-delivery value to the lowest postpartum hemoglobin value recorded during hospitalization. Hemoglobin levels will be routinely measured 24-48 hours after vaginal delivery; if additional hemoglobin measurements are obtained later during hospitalization, the lowest recorded value will be used for analysis.
次要结局
- Intravenous Iron Administration(From delivery through postpartum Day 3.)
- Clinically Diagnosed Postpartum Hemorrhage(From delivery until hospital discharge, assessed up to 4 days postpartum)
- Need for Additional Treatment for Postpartum Hemorrhage(From delivery through 24 hours postpartum)
- Receipt of Blood Products(Proportion of participants receiving blood products during the first 3 days postpartum.)
- Length of Hospital Stay(From delivery to hospital discharge. Most participants are discharged within 36-48 hours postpartum; however, follow-up continues until hospital discharge for participants with prolonged hospitalization due to maternal complications.)
- Composite Adverse Maternal Outcome(From delivery to hospital discharge. Most participants are discharged within 36-48 hours; participants with prolonged hospitalization will be followed until discharge (up to 30 days postpartum))