Transdermal Nitroglycerin and Nifedipine for Managing Preterm Labor: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 112
- 主要终点
- Time of Delivery
研究概览
简要总结
One of the important complications of pregnancy is preterm labor (PTL) and delivery. There are different tocolytic agents to enhance the time of delivery. The aim of this study was to compare the effect of transdermal nitroglycerin (glyceryl trinitrate, GTN) and oral nifedipine for managing preterm labor. This was a randomized clinical trial in women admitted with diagnosis of PTL. Group one have received transdermal GTN whereas group two have received oral nifedipine, vital signs, FHR, contractions, dilation and effacement as well as gestation age at the time of delivery have been monitored and evaluated in both groups of patient. Our main goal has been delay of delivery to have the most beneficial effect of primary corticosteroid administration for fetus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •GA between 24 to 34 weeks
- •early-onset signs of delivery (≥4 uterine contractions during 20 minutes, ≥1 centimeters (cm) of dilation and effacement over 80%).
排除标准
- •maternal or fetal life-threatening conditions which require emergency termination
- •multiple pregnancy
- •premature rupture of membrane
- •fatal anomaly or intra-uterine fetal death
- •cervical dilation ≥4 cm
- •any tocolytic treatment in previous days and positive allergy to GTN
研究组 & 干预措施
Group one have received Transdermal nitroglycerin
transdermal GTN (Schwarz Pharma AG, Monheim, FRG) were prescribed and placed on the patient forearm. Each patch contained 37.4 mg of glyceryl trinitrate which was released in blood stream (10mg/24hour). After one hour of the first patch application, the uterine contractions were evaluated.
干预措施: Transdermal nitroglycerin (Drug)
Group two have received nifedipine
For the nifedipine group, nifedipine 5mg softgel (Daana Pharma Co., Tabriz, Iran) was prescribed. In this group, the order of medicine prescription was as below;
- One softgel every 20 min (4 doses)
- Two softgel every 6 hr (4 doses)
- One softgel every 6 hr (4 doses)
- One softgel every 8 hr (3 doses) Likewise, the uterine contractions were checked every one hour and if the contraction didn't subside or there was any change in dilation and effacement, the treatment were stopped and another tocolytic were applied.
干预措施: nifedipine (Drug)
结局指标
主要结局
Time of Delivery
时间窗: Delivery
次要结局
- APGAR scores(Delivery)
研究者
Payam Peymani
Head Of Biostatistics Department, Health policy Research Center,Shiraz university of Medical Sciences
Shiraz University of Medical Sciences