The Efficacy of Adding Preoperative Rectal Misoprostol for Decreasing Intraoperative and Postoperative Blood Loss at Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 282
- 主要终点
- Intraoperative and postoperative blood loss
研究概览
简要总结
This randomized controlled trial aims to evaluate the efficacy of adding preoperative rectal misoprostol to standard oxytocin for reducing intraoperative and postoperative blood loss in women undergoing elective cesarean section. Misoprostol is a prostaglandin E1 analogue that is inexpensive, heat-stable, and effective as a uterotonic agent. The study will compare outcomes between two groups: women receiving oxytocin alone and women receiving oxytocin plus rectal misoprostol. The primary outcome is the reduction of blood loss during and after surgery. Secondary outcomes include changes in hemoglobin levels, need for additional uterotonics, maternal safety, and overall recovery.
详细描述
Postpartum hemorrhage (PPH) is a leading cause of maternal morbidity and mortality worldwide, with increased risk following cesarean section compared to vaginal delivery. Oxytocin is the standard uterotonic agent used to prevent PPH, but it has several limitations including the need for refrigeration and potential cardiovascular side effects when administered rapidly.
Misoprostol, a prostaglandin E1 analogue, has gained attention as an effective alternative or adjunct to oxytocin because it is heat-stable, inexpensive, widely available in tablet form, and can be administered by various routes. The rectal route is particularly advantageous, providing rapid absorption, sustained uterine contraction, and fewer gastrointestinal side effects. However, its onset of action is slower than oxytocin, which may affect intraoperative hemostasis if uterine tone is not achieved quickly.
This study is designed as a randomized controlled trial conducted at the Department of Obstetrics and Gynecology, Assiut University Hospital. Eligible participants will be women aged 18-45 years with singleton pregnancies at ≥37 weeks of gestation undergoing elective cesarean section. Participants will be randomized into two groups:
Group A (Control): Oxytocin only, given according to hospital protocol immediately after delivery of the baby and placenta.
Group B (Intervention): Oxytocin plus a single rectal dose of misoprostol (600-1000 µg, based on risk profile) administered immediately after delivery of the baby and placenta.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The study will be conducted in a blinded manner. Neither the participants nor the outcome assessors will know the treatment allocation. Care providers administering the intervention will also be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 years.
- •Singleton pregnancy at ≥37 weeks of gestation.
- •Elective cesarean section planned under spinal anesthesia.
- •Hemodynamically stable prior to surgery.
- •Provided written informed consent.
排除标准
- •Multiple pregnancy.
- •Antepartum hemorrhage (e.g., placenta previa, abruption).
- •Coagulopathy, thrombocytopenia, or anticoagulant therapy.
- •Severe medical comorbidities (e.g., uncontrolled hypertension, cardiac disease, hepatic or renal impairment).
- •Known allergy or contraindication to prostaglandins or oxytocin.
- •Intrauterine fetal death or major fetal anomaly.
- •Refusal to participate.
研究组 & 干预措施
Control: Oxytocin only
Description: Participants receive standard intraoperative uterotonic therapy with oxytocin according to hospital protocol immediately after delivery of the baby and placenta. Standard perioperative care (spinal anesthesia, prophylactic antibiotics, fluid management, monitoring) is provided. Rescue uterotonic measures and transfusion given as clinically indicated.
干预措施: Oxytocin (Drug)
Intervention: Oxytocin + Rectal Misoprostol
Participants receive the same oxytocin regimen as Arm 1 plus a single rectal dose of misoprostol (600-1000 µg depending on risk profile) administered immediately after delivery of the baby and placenta. Standard perioperative care is identical to Arm 1. Rescue uterotonic measures and transfusion given as clinically indicated.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Intraoperative and postoperative blood loss
时间窗: From skin incision until 24 hours after cesarean delivery
Total blood loss will be measured intraoperatively by suction canister volume (minus irrigation fluid) and gravimetric method (weighing surgical pads/swabs), and postoperatively by weighing perineal pads up to 24 hours.
次要结局
- Change in Hemoglobin and Hematocrit(Preoperative (within 24 hours before surgery) and 24 hours postoperative)
研究者
Amira Zanaty Khalaf Abbas
Resident, Obstetric and Gynecology Department
Assiut University