Carbetocin Versus Oxytocin Plus Misoprostol in Decreasing Intraoperative Blood Loss in Women Undergoing Planned Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- estimated blood loss in millimeters
研究概览
简要总结
The aim of this clinical trial is to test if carbetocin is as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section.
The main question it aims to answer is:
* Is carbetocin as effective as oxytocin plus misoprostol in decreasing intraoperative blood loss in women undergoing planned cesarean section?
Researchers will compare 2 groups:
- women receiving Oxytocin plus Misoprostol;
- women receiving Carbetocin as regards:
- estimated blood loss
详细描述
- Type of Study: A randomized controlled clinical trial.
- Study Setting: This study will be conducted in Ain Shams University Maternity Hospital (ASUMH).
- Study duration: 6 months.
- Study population: Women will be recruited from outpatient antenatal clinic of ASUMH.
Sample Size:
104 patients will be enrolled in this study and will be divided into two groups:
- Group A: 52 patients will receive+ Oxytocin (20 IU IV infusion on 1000 ml of normal saline solution) plus misoprostol (600 micrograms rectal). ( The control group )
- Group B: 52 patients will receive 100 micrograms Carbetocin IV slowly. Sample size justification By using PASS 11 software for sample size calculation, setting power at 80%, alpha error at 5% and after reviewing previous study results showed that the haemoglobin level (g/dl) postoperative to caesarean section was higher among women took Carbetocin than those took misoprostol (10.13 ± 0.76 versus 9.57 ± 0.95 respectively); based on that, a sample size of at least 90 pregnant females undergoing elective caesarean section divided randomly into 2 intervention groups [Carbetocin and misoprostol with oxytocin] (45 patients in each group) will be sufficient to achieve study objective, yet the drop out rate 17% so 7 patients will be added in each group.
Procedures:
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
- Double (Participant, Outcomes Assessor)
盲法说明
Eligible patients will be randomised & allocated into 2 groups (A) & (B). Randomization will be done using computer generated list.
Allocation & concealment will be done using sealed envelopes prepared according to computer generated list into ratio 1:1.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women planning to deliver by CS.
- •Age between 18-
- •Gestational age: (36-42 weeks).
排除标准
- •Women in active labour.
- •Rupture of membranes more than 24 hours &/or intraamniotic infection.
- •Suspected extensive adhesions eg: more than P3CS, endometriosis, previous pelvic surgery.
- •Antepartum hemorrhage and abnormal placentation e.g.: low lying placenta, placenta previa, placenta accreta.
- •Major intrapartum hemorrhage more than 1000 ml.
- •History of postpartum hemorrhage.
- •Anemia (Hb level less than 10g/dl).
- •Uterine overdistention eg: polyhydramnios, macrosomic baby, multiple pregnancy.
- •Known allergy to any of misoprostol, oxytocin, carbetocin.
- •Known medical disorders: Diabetes Mellitus, hypertensive disorders, Systemic Lupus Erythematosus.
- •Known coagulopathy problem.
- •Contraindication &/or refusal to spinal anesthesia.
研究组 & 干预措施
Oxytocin+Misoprostol
Patients in this group will receive 600 micrograms misoprostol rectally immediately before sterilization plus 20 IU Oxytocin IV infusion on 1000 ml of normal saline solution immediately after delivery of the fetus.
干预措施: Oxytocin + misoprostol (Drug)
Carbetocin
Patients in this group will receive 100ug Carbetocin by slow IV infusion (over one minute) intra-operative immediately after delivery of the fetus.
干预措施: Carbetocin (Drug)
结局指标
主要结局
estimated blood loss in millimeters
时间窗: calculated once at the end of the CS
estimated blood lost during the cesarean section (CS)
次要结局
- drop in hemoglobin(calculated once after 24hours of the CS)
研究者
Rania Hassan Mostafa
Principal investigator
Ain Shams Maternity Hospital