A One Year Double Blind Randomized Controlled Trial of Sublingual Misoprostol (400 µg) Versus Intramuscular Oxytocin (10 IU) in the Prevention of Postpartum Bloodloss at KLE Hospital, Belgaum
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 652
- 试验地点
- 1
- 主要终点
- mean blood loss
研究概览
简要总结
Sublingual misoprostol produces rapid peak concentration and is more effective than oral misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have 30 ml less average blood loss than women receiving oxytocin, the standard of care for prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial of .652 consenting, eligible pregnant women admitted to the labor room of the teaching hospital at J N Medical College, Belgaum, India. Women participating in the study were assigned by computer generated randomization to receive the study medications and placebos within one minute after clamping and cutting the umbilical cord. We also looked at the drugs effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with a gestational age >28weeks
- •singleton pregnancy with cephalic presentation anticipating a normal spontaneous vaginal delivery (including episiotomy)
- •a haemoglobin ≥ 8g/dl upon presentation who were admitted to labour room in the KLE teaching hospital attached to J N Medical College, Belgaum
排除标准
- •Women with pregnancy induced hypertension
- •antepartum haemorrhage
- •previous caesarean section or presence of uterine scar
- •diagnosed chorioamnionitis
- •oxytocin induction or augmentation of labour
- •intrauterine death
- •diagnosed medical disorders (such as diabetes, cardiac, renal and hepatic diseases, etc.) or those in active labour (defined as >4 cm dilatation)
研究组 & 干预措施
Sublingual misoprostol
400 µg powdered misoprostol administered sublingually; IM placebo
干预措施: Misoprostol (Drug)
Oxytocin
10 IU IM oxytocin; placebo powder
干预措施: Oxytocin (Drug)
结局指标
主要结局
mean blood loss
时间窗: 2 hours after delivery
Blood loss was objectively measured using the BRASSS-V DrapeTM, placed under the buttock before the delivery. The calibrated blood collection receptacle was opened after the delivery and drainage of amniotic fluid. Blood collected in the drape was transferred to measuring jar with 10 ml calibrations for accuracy. Blood soaked swabs were weighed in grams, and the known dry weight of the swabs was subtracted; this volume was added to the drape's measured blood volume (assuming 1 gm equivalence with 1 ml).
postpartum hemorrhage (Blood loss >500 mls)
时间窗: 2 hours after delivery
Blood loss was objectively measured using the BRASSS-V DrapeTM, placed under the buttock before the delivery. The calibrated blood collection receptacle was opened after the delivery and drainage of amniotic fluid. Blood collected in the drape was transferred to measuring jar with 10 ml calibrations for accuracy. Blood soaked swabs were weighed in grams, and the known dry weight of the swabs was subtracted; this volume was added to the drape's measured blood volume (assuming 1 gm equivalence with 1 ml).
次要结局
- The percent of women experiencing a ≥10% postpartum decline in haemoglobin(At presentation for delivery and 12-48 hours after delivery)
- Medication side effects(2 hours after delivery)