A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 8
- 主要终点
- C-Section
研究概览
简要总结
The purpose of this study is to determine if intrapartum use of a glucose-containing solution will improve the outcomes in pregnant women and their babies.
详细描述
This will be a multi-center, prospective, single-blind randomized trial of two types of IV fluids for maintenance hydration during labor. This study will be conducted at 4 sites: Reading (Reading Hospital), Allentown (Lehigh Valley), St. Luke Hospital and Hershey (Penn State College of Medicine). It will include 1524 pregnant women at ≥ 36 weeks presenting in spontaneous labor for anticipated delivery.
The primary research hypothesis is that intravenous hydration during labor with a glucose-containing fluid will lead to more efficient uterine contractility and will lead to a reduction of cesarean delivery. The primary outcome measure is the occurrence of a cesarean birth during the study period. The primary analysis will use an intent-to-treat approach to examine differences between the two IV fluid treatments in the proportion of deliveries requiring cesarean section.
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
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of any age with a singleton gestation in spontaneous labor at greater than or equal to 36 weeks without contraindication to participation.
- •These women will be in good health and candidates for vaginal delivery.
排除标准
- •Patients who are not candidates for vaginal delivery. This may be due to fetal malpresentation, prior cesarean section, multiple gestations, etc.
- •Patients presenting for induction of labor or requiring induction upon admission.
- •Patients presenting for scheduled cesarean section.
- •Patients with any form of diabetes or glucose dysregulation condition.
- •Concurrent use of steroids.
- •Patients presenting in active labor with advanced cervical dilation (≥ 6 cm).
- •Subjects participating in another labor and delivery related clinical trial that conflicts with this trial (as determined by the site PI).
结局指标
主要结局
C-Section
时间窗: From onset of labor to delivery
Compare c-section rates between the D5LR and LR treatment groups
次要结局
- Time to Delivery(From onset of labor to delivery)
- Oxytocin Augmentation(From onset of labor to delivery)
研究者
Richard S. Legro, M.D.
Professor, Obstetrics and Gynecology and Public Health Sciences
Milton S. Hershey Medical Center