Success Rate of Intracervical Balloon Placement With Nitrous Oxide Administration. A Randomized Control Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- success rate of intracervical balloon placement
研究概览
简要总结
This randomized controlled trial aims to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor.
详细描述
This is a single center randomized controlled trial aimed to compare the effectiveness of nitrous oxide versus oxygen in facilitating the successful placement of a Foley balloon catheter for cervical ripening and induction of labor. Pregnant women requiring labor induction will be randomly assigned to receive either nitrous oxide or oxygen during their Foley balloon placement. The primary outcome measured will be the success rate of the Foley balloon placement, with secondary outcomes including patient comfort, pain levels during the procedure, and any adverse effects. The study seeks to determine if nitrous oxide can improve the success rate of Foley balloon placement compared to oxygen and to evaluate the overall patient experience and safety associated with its use in this context.
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
- Single (Participant)
盲法说明
Subjects won't be told which group they are assigned. Care providers will be told which group subject is assigned.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients admitted to labor and delivery for induction of labor (term inductions, medically indicated preterm inductions).
- •Pregnant patients who are eligible for intracervical balloon placement.
排除标准
- •Pregnant patients with contraindications to receiving nitrous oxide.
- •Inability to safely self-administer nitrous oxide
- •Allergy to nitrous oxide
- •History of malignant hyperthermia,
- •Concomitant administration of magnesium sulfate
- •Less than 35 weeks gestational age
- •Non-reassuring fetal heart tracing
- •Use of intravenous or intramuscular opioid within 4 hours
- •Vitamin B12 deficiency
- •Gas-trapping conditions such as pneumothorax or small bowel obstruction
- •Patients requesting neuraxial anesthesia
- •Non-English speaking patients.
研究组 & 干预措施
Nitrous Oxide
Patients in the intervention arm will receive an inhalant of 50% nitrous 50% oxygen intended to target pain relief for the duration of their foley ballon placement.
干预措施: Nitrous oxide (Drug)
Oxygen
Patients in the control arm will receive an inhalant of 50% oxygen for the duration of their foley balloon placement.
干预措施: Oxygen (Drug)
结局指标
主要结局
success rate of intracervical balloon placement
时间窗: 15 minutes
successful placement of intracervical ripening ballon on first attempt
次要结局
- Pain Relief(15 minutes)
研究者
Jefferson Drapkin
Research Manager
Maimonides Medical Center