Efficacy of Sildenafil Citrate to Reduce the Rate of Cesarean Section for Intrapartum Fetal Distress During Induction of Labor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- The rate of cesarean section for intrapartum fetal distress
研究概览
简要总结
Induction of labour (IOL) is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean section. The most common causes are failed induction and intrapartum fetal distress. In spite of significant advances in methods of IOL and intrapartum fetal monitoring, no interventions are proven to reduce the development of intrapartum fetal distress
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
- 否
入选标准
- •Singleton pregnancy.
- •Pregnant ≥ 37 weeks gestation.
- •Fetus with longitudinal lie and vertex presentation.
- •Healthy fetus with EFW>2500 gm
排除标准
- •Patients with previous cesarean delivery or uterine surgery.
- •Antepartum hemorrhage.
- •Cephalopelvic disproportion.
- •Category II or III non-stress test.
- •Medical disease as hypertension, cardiac, renal and hepatic disorders
- •Intrauterine fetal death.
- •Fetal growth restriction.
- •Fetuses with major congenital malformations.
- •Women taking any anti-hypertensive medication, alpha-adrenergic blocking agents, calcium channel blockers (verapamil), nitrates, medications used to treat pulmonary arterial hypertension, and other phosphodiesterase type 5 inhibitors.
- •Women with a contra-indication to sildenafil treatment such as hypersensitivity to sildenafil.
研究组 & 干预措施
study group
50 mg oral sildenafil citrate tablet
干预措施: Sildenafil 50 mg (Drug)
placebo group
placebo tablets of the same shape, color and size of sildenafil citrate tablets
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
The rate of cesarean section for intrapartum fetal distress
时间窗: 24 hours
Fetus will be considered to be distressed if Ominous fetal heart rate changes led to cesarean section was present
次要结局
未报告次要终点
研究者
Ahmed Mohamed Abbas
Principal investigator
Assiut University