跳至主要内容
临床试验/NCT02115256
NCT02115256终止2 期

Intravenous Terbutaline Versus Intravenous Nitroglycerine for External Cephalic Version: A Double-Blinded Randomized Controlled Trial in Nulliparous Women

Yaakov Beilin1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
6
试验地点
1
主要终点
Successful Version of the Fetus Into the Vertex Position

研究概览

简要总结

Breech presentation of a term pregnancy is a common occurrence. A procedure known as external cephalic version (ECV) is frequently used by obstetricians to turn the baby into the vertex position prior to delivery in order to avoid a cesarean section and the associated risks. Medications to relax the uterus, known as tocolytics, are used in conjunction with the procedure as they have been shown to improve the success rate of ECV, but with inconsistent, varying results.

详细描述

Breech presentation occurs in approximately 3-4% of all births and all women with breech presentation at term undergo cesarean delivery. The only way to avoid a cesarean is to manually turn the baby prior to the date of delivery, a procedure known as elective external cephalic version (ECV). ECV has been shown to reduce the frequency of breech presentation at term and thus lessen the risks associated with breech delivery and those of cesarean section, with little risk to the mother or baby. Tocolysis, administered immediately prior to the ECV and commonly used at The Mount Sinai Hospital, has been shown to improve the success rate of ECV. Several different agents are known to cause tocolysis. These include beta-mimetics (ritodrine, terbutaline), nitroglycerine (NTGL) and nifedipine.Terbutaline has been shown to improve success rate of ECV. Another study published in 2004 by El-Sayed et al showed that subcutaneous terbutaline was associated with higher rates of successful ECV than IV NTGL in term patients. There is inconsistent data in regard to the success rate of ECV with NTGL. In a study published in 2003 by Bujold et al, NTGL was associated with a higher rate of side effects and a lower rate of successful ECV when compared to ritodrine. Another study published in 2009 by Hilton et al showed that NTGL was more efficacious for ECV in nulliparous versus multiparous women. Yet another study published in 2009 by Yanny et al showed no differences between sublingual NTGL versus placebo in efficacy, and reported no significant side effects. A study published in 2003 by Bujold et al showed that sublingual NTGL was associated with a higher incidence of headache and did not improve the success rate of ECV. It may be beneficial to use NTGL instead of terbutaline because NTGL is a shorter acting agent and the procedure itself only lasts 10-15 minutes. Additionally, both medications have side effects. Terbutaline is associated with maternal tachycardia, hyperglycemia, hypokalemia, pulmonary edema, cardiac arrhythmias, hypertension and myocardial ischemia, and NTGL is associated with maternal nausea, vomiting, headache, and hypotension. For both medications the side effects are self- limiting but depending on the patient's co-morbidities one drug may be beneficial for that individual patient.

To date no study has compared the efficacy of intravenous terbutaline versus intravenous NTGL in women presenting for ECV. The purpose of this study is to determine if the success rate of ECV can be improved with the use of IV NTGL.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Between 18-35 years of age
  • 37 weeks gestation
  • Breech presentation

排除标准

  • Patients with ruptured membranes
  • Multiple gestation
  • Maternal age (age > 35)
  • With known medical comorbidities (including hypertension (HTN), arrhythmias, endocrinologic diseases such as diabetes and thyroid disease, scoliosis, asthma)
  • Allergies to nitroglycerine or terbutaline
  • Prior abdominal or uterine surgery

研究组 & 干预措施

Intravenous Terbutaline

Active Comparator

0.25 mL of Intravenous Terbutaline

干预措施: Intravenous Terbutaline (Drug)

Intravenous Nitroglycerine

Active Comparator

IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.

干预措施: Intravenous Nitroglycerine (Drug)

结局指标

主要结局

Successful Version of the Fetus Into the Vertex Position

时间窗: average of 1 hour

Number of participants that had successful version of the fetus into the vertex position.

次要结局

  • Tachycardia(average of 1 hour)
  • Hypotension(average of 1 hour)
  • Need for Cesarean Delivery(average of 1 hour)

研究者

发起方
Yaakov Beilin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yaakov Beilin

Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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