Intrapartum Hydration and Rate of Cesarean Delivery Among Nulliparous at > 37 Weeks: A Multicenter Randomized
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 670
- 试验地点
- 2
- 主要终点
- rate of cesarean section
研究概览
简要总结
The hypothesis of the present study is the hydration of nulliparous women with 250ml/hour vs. 125ml/hrs would decrease the rate of primary cesarean section.
详细描述
For this non-blinded randomized clinical trial (RCT) we will recruit approximately 670 women which meet the inclusion criteria across three sites (Eastern Virginia Medical School (EVMS), University of Arkansas for Medical Sciences (UAMS) and Obstetrix Medical Group, in California). When the patient is being scheduled for induction by her physician or when she presents to L&D for induction or in labor, but her cervical dilation on admission is less than 4 cm, the participants will be consented, and then randomized into a study intervention group. Both groups will receive maintenance IV hydration with Lactated Ringer's (LR) solution: Group I will receive LR at 125 ml/hr and group II will receive LR at 250ml/hr. Other than the rate of maintenance IV infusion, the two groups will receive routine intrapartum care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Non-anomalous singleton
- •Nulliparous (no prior delivery after 20 weeks)
- •Presenting at ≥37 weeks of gestation
- •Presenting for anticipated induction of labor or spontaneous labor (regular contractions for more than 2 hours), but cervical dilation less than 4 cm
- •Rupture of membranes
- •Expected to deliver at one of the participating hospitals
排除标准
- •Not in the inclusion criteria
- •Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma)
- •Diabetes mellitus-gestational or pre-gestational
- •Enrollment in another randomized clinical trial
- •Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia)
- •Hypertension (chronic or pregnancy induced) before randomization
- •HIV (human immunodeficiency virus)
- •Placenta previa / 3rd trimester bleeding
- •Renal insufficiency (serum creatinine > 1.5 mg/dL)
- •Restrictive lung disease
- •Seizure disorder on medication
- •Thyroid disease on medication
- •Any contraindications to vaginal delivery (breech, active herpes, schedule cesarean, abnormal fetal heart tracing)
结局指标
主要结局
rate of cesarean section
时间窗: 5 Years
The primary objective of this multi-center RCT is to determine if hydration with 250 ml/hr, when compared to traditional 125 ml/hr, significantly decreases the rate of primary cesarean delivery nulliparous.
次要结局
- labor(5 Years)