Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Blood loss during cesarean sections
研究概览
简要总结
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial
详细描述
This study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at Ain Shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( Ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.All C.S will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20IU of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during C.S will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnancies
- •women booked for elective C.S
- •full term pregnancies
- •primi gravida or previous one delivery ( either by spontaneous vaginal delivery or C.S )
排除标准
- •blood disorders
- •multiple pregnancy
- •placenta previa
- •polyhydramnios
- •marked maternal anemia
- •contraindications to prostaglandin e.g history of asthma , allergy to misoprostol
- •previous 2 or more C.S
研究组 & 干预措施
Misoprostol oral tablets
79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping
干预措施: Misoprostol Oral Tablet (Drug)
Ranitidine oral tablets
79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping
干预措施: Ranitidine Oral Tablet (Drug)
结局指标
主要结局
Blood loss during cesarean sections
时间窗: through study completion, an average of 1 year
Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta
次要结局
- Change in blood pressure and pulse(through study completion, an average of 1 year)
- Blood loss after 24 hr.(through study completion, an average of 1 year)
- Need for additional uterotonic agent(through study completion, an average of 1 year)
- Vaginal bleeding(through study completion, an average of 1 year)
- Need for blood transfusion(through study completion, an average of 1 year)
- Need for surgical measures to stop bleeding(through study completion, an average of 1 year)
- Side effects of misoprostol(through study completion, an average of 1 year)
研究者
Mohamed Fathy
Resident of obstetrics and gynecology
Ain Shams Maternity Hospital