The Efficacy and Safety of Intrauterine Misoprostol Versus Rectal Misoprostol in Reducing Blood Loss During and After Cesarean Section
试验速览
- 阶段
- 2 期
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- estimated blood loss during and after CS
研究概览
简要总结
98 pregnant women attending for CS will be randomized into 2 groups. Rectal misopristol group who will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion and intrauterine misopristol group will receive 400 microgram misoprostol intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta. The estimated blood loss for each patient will be measured and data of both groups will be compared.
详细描述
The study we will include (98) pregnant women attending for cesarean delivery in the Kasr Elaini hospital (faculty of medicine - Cairo university).After signing informed written consent, all participants will be subjected to: Full medical history(including full obstetric history and current pregnancy history and the 1st day of last menstrual period), thorough clinical examination (general and full obstetric examination), obstetric ultrasonography (to confirm gestational age and the eligibility of the current pregnancy to participate in the study) and preoperative laboratory tests (including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests).
Group allocation: On the day of the cesarean delivery, participants will be randomly assigned in a 1:1 ratio into two groups; group A (Rectal misoprostol) and group B (Intrauterine misoprostol). Randomization will be performed using computer-generated random numbers and only the participants will be masked to the group allocation.
Group A (Rectal misoprostol - n=49) will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion while group B (Intrauterine misoprostol n=49) will receive 400 microgram misoprostol (cytotec, Pfizer, G.D. Searle LLC) inserted intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta.
Following the delivery of the baby, patients in both groups will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h).
All cesarean sections will be done under spinal anesthesia by the following operative steps: pfannenstiel incision, transverse lower uterine segment incision, immediate cord clamping (< 30 seconds) and the placenta will be removed by controlled cord traction after its spontaneous separation, closure of uterus in 2 layers, closure of anterior abdominal wall in anatomical manner (adequate hemostasis will be ensured in all operative steps).
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women candidate for CS.
- •Full term singleton living pregnancies (> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan).
- •Spinal or epidural anesthesia for the CS.
排除标准
- •Maternal Anemia (hemoglobin <9 g%)
- •Maternal medical disorders (e.g. cardiac, renal, and hepatic diseases, or coagulopathies).
- •Fetal anomalies or IUGR (estimated fetal weight below the 5th centile)
- •Risk of obstetric hemorrhage (e.g. peripartum hemorrhage, abnormal placentation, previous history of uterine atony or postpartum hemorrhage).
- •Women attending for emergency CS.
- •More than 2 previous CS procedures.
- •Prolonged procedure (more than 2 hours from skin incision to skin closure).
- •History of prostaglandin allergy.
研究组 & 干预措施
rectal misopristol
will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion.
干预措施: Misoprostol (Drug)
intrauterine misopristol
will receive 400 microgram misoprostol inserted intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta.
干预措施: Misoprostol (Drug)
结局指标
主要结局
estimated blood loss during and after CS
时间窗: within 12 hours after delivery
EBL= EBV x { (Preoperative hematocrit - Postoperative hematocrit) ÷ Postoperative hematocrit} Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).
次要结局
- The occurrence of any fetal side effects (rectal group only)(within 24 hours after the CS procedure)
- estimated blood loss during CS(within the CS procedure)
- Use of additional ecbolics denoting uterine atony(within CS procedure)
- The occurrence of any maternal side effects (in both groups)(within 24 hours after the CS procedure)
研究者
Moutaz Sherbini
assistant professor
Cairo University