Comparison of the Efficacy of Sublingual Misoprostol and Intravenous Tranexamic Acid for Postpartum Hemorrhage Prophylaxis in Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Comparison of patients' postoperative shock indices
研究概览
简要总结
Postpartum hemorrhage (PPH) is an obstetric emergency, with an estimated incidence ranging from 2.8% to 7.9%. Recent studies indicate an increasing trend in the frequency of PPH.Although it is more commonly seen in developing countries, it remains a significant cause of maternal morbidity and mortality worldwide. Therefore, early diagnosis and prompt, accurate intervention are critically important.
Despite the rising incidence of PPH, maternal mortality rates have declined. This improvement is largely attributed to better identification of risk factors, timely diagnosis, and effective intervention.
To prevent PPH globally, active management of the third stage of labor has been widely implemented. This approach includes the use of pharmacologic agents, uterine massage, and controlled traction for placental delivery.Among pharmacological agents, the most commonly used include oxytocin, ergot alkaloids (e.g., ergometrine), tranexamic acid, prostaglandin E1 (misoprostol), prostaglandin F2α, and oxytocin analogues (e.g., carbetocin).Oxytocin is the most widely used agent for PPH prophylaxis.
The aim of this study is to compare the efficacy of tranexamic acid and misoprostol in the prophylaxis of postpartum hemorrhage.
详细描述
The study included elective cases scheduled for repeat cesarean delivery (women with a prior cesarean delivery) at the Obstetrics and Gynecology Clinic, Maternity Ward of Etlik City Hospital, between December 2023 and December 2024.
Patients were divided into three groups. Group 1 received tranexamic acid (Transamin 10% ampoule, 2.5 mL/250 mg, Actavis Pharmaceuticals, Turkey); 1 gram was administered intravenously during the lower uterine segment incision. Group 2 received misoprostol (Cytotec, 200 mcg tablet, Pfizer Inc., USA); 400 mcg were administered sublingually immediately after delivery and cord clamping. Group 3 (control) received no additional pharmacological agent. All patients received 20 IU oxytocin (Synpitan Forte, 5 IU/mL ampoule, IM/IV, Deva Holding A.Ş., Turkey).
Despite treatment, in cases of intraoperative or postoperative hemorrhage due to uterine atony, additional interventions were performed (additional oxytocin, Bakri balloon, uterine/hypogastric artery ligation, B-Lynch/Hayman sutures, or hysterectomy); these patients were excluded from the final analysis.
Parameters examined: operative time; preoperative and 24-hour postoperative hemoglobin and hematocrit; pulse rate and shock index at 0 and 24 hours; postoperative complications; and blood transfusion requirement.
Sample size was estimated using G*Power 3.1. With α = 0.05, 80% power, and three study arms, the required sample size was calculated as 156 participants (52 per group). Seventy participants were initially enrolled per group to allow for losses; after exclusions, 192 participants (60 misoprostol, 67 TXA, 65 control) were included in the final analysis. Statistical analysis was performed using SPSS version 27. A 95% confidence interval was used, and p < 0.05 was considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Patients aged 18-45 years Gestational age between 37 and 41 weeks Prior cesarean delivery (repeat elective cesarean section) Performed cesarean section for delivery
排除标准
- •did not provide informed consent,
- •with comorbidities (such as heart, liver, or lung diseases),
- •high-risk pregnancy (e.g., intrauterine growth restriction, cholestasis, preeclampsia, eclampsia, multiple pregnancies)
- •known allergies to tranexamic acid or misoprostol
- •known coagulation disorders
研究组 & 干预措施
Control Group
Participants received routine oxytocin prophylaxis only (Synpitan Forte, 20 IU IM/IV), with no additional pharmacological agent.
Tranexamic Acid (TXA) Group
Participants received 1 g intravenous tranexamic acid (Transamin) at the time of the lower uterine segment incision, in addition to routine oxytocin prophylaxis (Synpitan Forte, 20 IU IM/IV).
干预措施: Tranexamic acid (Drug)
Misoprostol Group
Participants received 400 mcg sublingual misoprostol (Cytotec) immediately after delivery and cord clamping, in addition to routine oxytocin prophylaxis (Synpitan Forte, 20 IU IM/IV).
干预措施: Misoprostol 200mcg Tab (Drug)
结局指标
主要结局
Comparison of patients' postoperative shock indices
时间窗: 24 hours
postoperative shock indices were compared at 0-24 hours postoperatively
Comparison of patients' preoperative and postoperative hemogram levels
时间窗: 24 hours
Hemogram values were compared at 0-24 hours postoperatively
Comparison of patients' preoperative and postoperative hematocrit levels
时间窗: 24 hours
Hematocrit values were compared at 0-24 hours postoperatively
次要结局
- operative time(Perioperative)
- Comparison of the patients' postoperative heart rate(24 hours)
研究者
Tuğba Ağbal
Clinical Doctor
Ankara Etlik City Hospital