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临床试验/NCT07550413
NCT07550413尚未招募2 期

Role of Intravenous Calcium to Decrease Blood Loss During Intrapartum Cesarean Section

Pak Emirates Military Hospital1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
182
试验地点
1
主要终点
Blood Loss

研究概览

简要总结

To determine the effectiveness of prophylactic intravenous calcium chloride administered after cord clamping in reducing postpartum blood loss during intrapartum cesarean section.

详细描述

After approval from the hospital's ethical review committee, written informed consent will be obtained from all participants. Baseline characteristics such as age, parity, gestational age, height, and weight for body mass index will be documented. A total of 182 women will be randomly allocated into two equal groups (91 each) using the lottery method. Group A will receive 1 g of intravenous calcium chloride diluted in 100 mL of normal saline, administered over 10 minutes beginning one minute after cord clamping, in addition to standard oxytocin therapy (10 IU intravenous bolus followed by 20 IU infusion). Group B will receive standard care with oxytocin alone.Quantitative blood loss will be calculated using the gravimetric method. All surgical swabs, drapes, and pads will be weighed immediately after use, and their pre-determined dry weights will be subtracted to obtain the net blood loss, with the assumption that 1 g of weight gain is equivalent to 1 mL of blood. Blood collected in suction containers will also be measured. Adjustment for amniotic fluid will be made by recording the volume of clear amniotic fluid suctioned immediately after uterine incision and before placental delivery, which will then be subtracted from the total suction volume. Each weighed item and suction measurement will be labeled sequentially according to the patient's study ID at the time of surgery. The labeling and confirmation will be carried out by a consultant obstetrician with more than five years of experience, in collaboration with the researcher, at the end of the procedure.All data will be recorded using a predefined proforma.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-45 years undergoing intrapartum cesarean section at ≥34 weeks of gestation.
  • Exposure to oxytocin during labor before CS.
  • Singleton pregnancy with no known fetal anomalies.

排除标准

  • Known bleeding disorders or preoperative coagulation abnormalities
  • Preeclampsia or hypertensive disorders contraindicate calcium use.
  • History of cardiac disease or arrhythmias
  • Placental abnormalities, i.e., placenta previa, accreta
  • Emergency CS with fetal distress or cord prolapse.
  • Known hypersensitivity to calcium chloride.

研究组 & 干预措施

Group A

Experimental

Group A will receive 1 g of intravenous calcium chloride diluted in 100 mL of normal saline, administered over 10 minutes beginning one minute after cord clamping, in addition to standard oxytocin therapy (10 IU intravenous bolus followed by 20 IU infusion).

干预措施: Calcium Chloride (Drug)

Group B

Placebo Comparator

Group B will receive standard care with oxytocin alone.

干预措施: Placebo (Other)

结局指标

主要结局

Blood Loss

时间窗: 24 hours

Quantitative blood loss will be calculated using the gravimetric method. All surgical swabs, drapes, and pads will be weighed immediately after use, and their pre-determined dry weights will be subtracted to obtain the net blood loss, with the assumption that 1 g of weight gain is equivalent to 1 mL of blood. Blood collected in suction containers will also be measured. Adjustment for amniotic fluid will be made by recording the volume of clear amniotic fluid suctioned immediately after uterine incision and before placental delivery, which will then be subtracted from the total suction volume. Each weighed item and suction measurement will be labeled sequentially according to the patient's study ID at the time of surgery.

次要结局

未报告次要终点

研究者

发起方
Pak Emirates Military Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Salma Nisar

Senior Registrar

Pak Emirates Military Hospital

研究点 (1)

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