Utility of Amniotic Fluid Analysis for Intrapartum Infection Prediction Model
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The number of patients who develop an intrapartum infection
研究概览
简要总结
This is a prospective study that will aid in ensuring the feasibility of timely and correct aspiration of amniotic fluid by study research team that include the clinical team taking care of the patient during her labor, timely transport and interpretation of specimens. It will also assist in providing information for the computation of necessary statistical measures (e.g. sample size, power analysis, etc.) for the study cohorts that lack the needed data in the medical literature.
详细描述
Can amniotic fluid be serially aspirated via an Intrauterine pressure catheter (IUPC) and successfully analyzed in labor? Do abnormal amniotic fluid results collected serially predict which laboring patients will develop an intrapartum infection? Can the results predict infection sooner than the current clinical diagnostic criteria as outlined by the 2015 NICHD guidelines? How do the sensitivity, specificity, positive and negative predictive values compare to the 2015 NICHD diagnostic criteria?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Gestational age ≥ 37 weeks
- •Age of participant ≥ 18 years old
排除标准
- •Multiple gestation
- •Gestational age < 37 weeks
- •Intrauterine fetal demise
- •Fetal anomalies
- •Pre-gestational Diabetics / Gestational Diabetics
- •Chronic immune suppression with steroids (defined as > 1 month of consistent steroid use)
- •Oligohydramnios
- •Women with documented non-obstetric infections within 2 weeks of admission; including use of any antibiotics within 2 weeks of admission for non-documented/suspected infections
- •Repeat temperature not performed within 45 minutes of index fever (100.4 F)
- •Index fever (100.4 F) is > 1 hour after delivery
- •Expectantly managed premature rupture of membranes
结局指标
主要结局
The number of patients who develop an intrapartum infection
时间窗: From enrollment to delivery
次要结局
未报告次要终点
研究者
Croslanda
Principal Investigator
Oregon Health and Science University