Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Need for Additional Uterotonic Medications
研究概览
简要总结
Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in women with risk factors for uterine atony decreases the need for additional uterotonic medications, uterine atony and postpartum hemorrhage.
Design: randomized, double-blinded, placebo-controlled trial.
详细描述
Patients and methods: 120 pregnant women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
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, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who underwent delivery either by elective or emergent cesarean section at 24 week gestation or later with preoperative levels of hemoglobin and hematocrit determined up to 72 hours prior to delivery. The patients must have at least one of the risk factors for uterine atony listed below:
- •Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).
- •Polyhydramnios (defined as Phelan´s amniotic fluid index > 24 cm)
- •Twin or Multiple pregnancy.
- •Prolonged labour (prolonged active phase > 12 hours) or precipitate labour(cervical dilatation ≥ 10 cm/hour).
- •Magnesium sulphate or any other tocolytic agent therapy for ≥ 8 hours before cesarean section.
- •Intravenous oxytocin therapy for at least 4 hours before cesarean section.
- •Multiparous women (≥ 3 prior abdominal or vaginal deliveries )
- •Clinical chorioamnionitis was defined as maternal temperature of ≥ 38°C in addition to more than one of the following criteria: fetal tachycardia (> 160 beats per minute), maternal tachycardia (>100 beats per minute, maternal leukocytosis (15,000 cells/mm3), uterine tenderness or foul smelling amniotic fluid.
- •Known myomatosis, uterine Müllerian malformations or those diagnosed by ultrasound.
排除标准
- •Misoprostol incorrect administration
- •Severe allergic, bleeding disorders (e.g., haemophilia); severe asthma or any other absolute contraindication to misoprostol use.
- •Any bleeding occurred before delivery (abruptio placentae, placenta praevia) or bleeding due to other causes different than uterine atony.
研究组 & 干预措施
Misoprostol
women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
干预措施: Misoprostol (Drug)
Folic Acid
women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.
干预措施: Folic Acid (Drug)
结局指标
主要结局
Need for Additional Uterotonic Medications
时间窗: 24 hours
The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis.
次要结局
- Postpartum Hemorrhage(24 HOURS)
- Blood Loss(24 hours)
- Uterine Atony(24 hours)
研究者
Flavio Hernández Castro
Principal Investigator
Hospital Universitario Dr. Jose E. Gonzalez