NCT06702670招募中2 期
Anticholinergics for Cervical Edema in Labor (ACCEL)
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年3月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of participants that achieve complete dilation of cervix (10cm)
研究概览
简要总结
The purpose of this study is to is to determine the clinical effectiveness of a single dose of intravenous (IV) medication for the prevention of labor arrest and cesarean delivery in primiparous women undergoing trial of labor.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primiparous
- •Viable single intrauterine pregnancy
- •≥ 34 weeks of gestation
- •Ruptured membranes
- •Category I tracing at time of inclusion
- •Active phase of labor (>=6 cm of cervix dilation)
排除标准
- •Category II or III tracing
- •Allergy to the study medication (IV Diphenhydramine)
研究组 & 干预措施
Treatment with Diphenhydramine
Experimental
干预措施: Usual Care (Combination Product)
Treatment with Diphenhydramine
Experimental
干预措施: Treatment with Diphenhydramine (Drug)
Usual Care
Active Comparator
干预措施: Usual Care (Combination Product)
结局指标
主要结局
Number of participants that achieve complete dilation of cervix (10cm)
时间窗: from start of treatment upto 6 hours
Number of participants that achieve complete dilation of cervix (10cm)
时间窗: from start of treatment upto 4 hours
次要结局
- Number of participants who have vaginal delivery after protracted labor(End of delivery (an average of upto 6 hours after start of treatment))
- Number of participants who have Postpartum complications captured as composite maternal morbidity(from hospitalization up to 6 weeks postpartum)
- Number of neonates that had adverse events(from birth up to 6 weeks post-delivery)
研究者
Samantha Antonioli
Resident
The University of Texas Health Science Center, Houston
研究点 (2)
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