Combined Nifedipine and Sildenafil Citrate Versus Nifedipine Alone in Acute Tocolysis of Preterm Labor: A Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 227
- 试验地点
- 2
- 主要终点
- the proportion of women remaining undelivered during the whole period of hospitalization. Treatment failure is considered in participants who delivered during this period, or those who need repeated treatment course.
研究概览
简要总结
The aim of this study is to assess whether or not the emergency tocolytic effect of combined nifedipine and sildenafil citrate will have a superior effect over nifedipine alone in terms of inhibiting eminent preterm labor and improving perinatal outcomes.
详细描述
Women will be randomly assigned into two study groups using a computerized random number table generator in order to get the trial sequence which will be hidden in sealed numbered opaque envelopes. Each envelope contains a single element (assignment) of the trial sequence. The statistician generated the random allocation sequence, and the investigators enrolled the participants.
Each patient will undergo an ultrasound examination prior to randomization to confirm GA, rule out major fetal anomalies and to determine cervical measurements. Dexamethasone in a total dose of 24 mg will be administered to all patients if not given in a previous admission.
Eligible women are then randomly assigned into two study groups:
Group I: (combined nifedipine and sildenafil citrate) The protocol for nifedipen in our units consists of 20 mg orally stat, followed by 10 mg orally every 6-8 hours, at the same time sildenafil citrate will be administered vaginally in a dose of 25mg at 8 hourly intervals and both medications will be continued for 48-72 hours as indicated.
Group II: (nifedipine alone) will receive therapy by nifedipine alone in the same regimen and duration described before.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant patients presented in outpatient clinic, admitted through emergency room or referred from any other hospitals will be the candidates for the study if they are of any age, any parity, carrying a singleton pregnancy, at a gestational age (GA) between 24 and 34 weeks, and whether or not they had a previous history of PTL.
排除标准
- •The presence of major fetal anomaly, intrauterine fetal death, advanced cervical dilatation (>4cm), membranes bulging into the vagina in asymptomatic women, history of ruptured membranes, major antepartum hemorrhage, major chronic medical disorder (such as chronic hypertension, chronic renal disease, and pre-gestational diabetes mellitus as these conditions would increase the risk of PTL and potentially confound the primary study outcome), twins or higher order multiple pregnancy, any other condition in which continuation of the pregnancy can harm the mother or fetus and any contraindication for nifedipin and/or nicorandil therapy.
研究组 & 干预措施
nifedipen and sildenafil
The protocol for nifedipen in our units consists of 20 mg orally stat, followed by 10 mg orally every 6-8 hours, at the same time sildenafil citrate will be administered vaginally in a dose of 25mg at 8 hourly intervals and both medications will be continued for 48-72 hours as indicated.
干预措施: nifedipen (Drug)
nifedipen and sildenafil
The protocol for nifedipen in our units consists of 20 mg orally stat, followed by 10 mg orally every 6-8 hours, at the same time sildenafil citrate will be administered vaginally in a dose of 25mg at 8 hourly intervals and both medications will be continued for 48-72 hours as indicated.
干预措施: Sildenafil (Drug)
nifedipen only
nifedipine alone in the same regimen and duration described before.
干预措施: nifedipen (Drug)
结局指标
主要结局
the proportion of women remaining undelivered during the whole period of hospitalization. Treatment failure is considered in participants who delivered during this period, or those who need repeated treatment course.
时间窗: 9 months
次要结局
- readmission after discharge(9 months)
- time (days) till delivery(9 months)
- maternal outcomes (gestational age at delivery, mode of delivery, any complications during delivery)(9 months)
- neonatal outcomes (weight, Apgar score, admission to neonatal intensive care unit(9 months)