Comparative Study Between the Roles of Intrauterine Misoprostol Versus the Sublingual Route for Prevention of Postpartum Blood Loss in Elective Cesarean Sections: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- The amount of blood loss
研究概览
简要总结
Study design:
A prospective randomized control trial was carried out at labor and delivery unit at Kasr Al Aini Hospital, Cairo University.
Population of study:
192 pregnant women at the age range from 20 to 35 years, with BMI < 30kg/m2 presenting with a full-term singleton healthy living fetus (gestational age >39 weeks confirmed by the first day of the last menstrual period or first-trimester ultrasound scan) and candidate for elective cesarean delivery (Previous one or two cesarean section) were included in our study. Patients with uterine over distension as due to multiple pregnancies or polyhydramnios, multipara (parity ≥3), women with uterine fibroids, antepartum hemorrhage presentation such as placenta previa, placental abruption or vasa previa, moderate to severe anemia with hemoglobin level <9mg/dl, patient on anticoagulant during pregnancy or having coagulopathy or thrombocytopenia or blood dyscrasias, hypertension, cardiovascular, DM, hepatic, or renal disorders and women with any contraindication for the use of misoprostol or oxytocin as allergy to prostaglandin and concomitant drugs that have drug interaction with prostaglandins as topical dinoprostone, antacids containing magnesium were excluded from our study.
详细描述
After receiving the research approval of the Scientific and Ethical Committee of the Obstetrics and Gynecology department, Cairo University, the study purpose was clarified simply and in a lay Arabic speech to all women before registering in the study, and the enrolled women signed informed consent form. Pregnant women who met all the inclusion criteria were evaluated for enrollment. Prior to the study, randomization schedules created by computer program were designed and settled in serially numbered secured opaque envelopes. Simple randomization was applied at one to one ratio within both groups. The recruited women - after giving consent for participation- opened the sealed randomization envelopes for revealing the allocation.
All participants were subjected to Comprehensive history taking including obstetric, medical, and surgical history.
General examination excluding the presence of any abnormalities. Systematic obstetrical examinations. A transabdominal ultrasound to confirm the diagnosis and evaluation of fetal condition.
A blood sample collected for complete blood counting, coagulation studies, liver and kidney function tests.
All women were subjected to elective lower segment cesarean section by the same team under spinal anesthesia and antibiotic prophylaxis according hospital protocol.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged 20-35 years.
- •BMI < 30kg/m
- •Singleton pregnancy.
- •Full term pregnancies (recruiting from 37 weeks of gestation).
- •Elective cesarean section (previous one or two cesarean section).
排除标准
- •Active labour before 39 weeks.
- •Uterine over distension as due to multiple pregnancies or polyhydramnios.
- •Multipara [parity ≥3].
- •Pregnancy with obstetric haemorrhage such as placenta Previa, placental abruption or vasa Previa.
- •Moderate to severe anemia with HB <9mg/dL.
- •Pregnancy with coagulopathy, thrombocytopenia or blood dyscrasias.
- •Women with uterine fibroids.
- •Medically complicated pregnancy (pregnancy induced hypertension, cardiovascular, DM, hepatic, or renal disorders).
- •Women with any contraindication for the use of misoprostol or oxytocin as a history of prostaglandin allergy and current medication which could cause severe drug interaction to prostaglandins such as topical dinoprostone, magnesium-containing antacids or quinapril.
研究组 & 干预措施
intrauterine misoprostol group (Group A)
96 women receiving 400 mcg intrauterine misoprostol + IV oxytocin.
干预措施: Misoprostol (Drug)
sublingual misoprostol group (Group B)
: 96 women receiving 400 mcg sublingual misoprostol + IV oxytocin.
干预措施: Misoprostol (Drug)
结局指标
主要结局
The amount of blood loss
时间窗: 6 hours
determined through the standardized visual estimation method and rectified by measuring the amount of intraoperative blood loss and 6 hours after surgery
次要结局
- Changes in Hemoglobin level measured by gm/dl in both groups after delivery(24 hours)
- Changes in hematocrit values in both groups after delivery(24 hours)
研究者
Adel Atef
assistant professor
Cairo University