Development of a Rapid Amniotic Fluid (AF) Test and a Non-Invasive Vaginal Fluid (VF) Test to Detect Intra-Amniotic Infection and Predict Preterm Birth in Women Presenting With Preterm Labor and Intact Amniotic Membranes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 10
- 主要终点
- performance of vaginal fluid test
研究概览
简要总结
A multi-centered, prospective study, involving pregnant women presenting to the labor and delivery unit of collaborating clinical study sites with preterm labor and intact amniotic membranes with and without suspected Intra-Amniotic Infection (IAI).
详细描述
A study on patients in preterm labor for whom the managing physician plans to perform amniocentesis to evaluate for possible infection using conventional, currently available methods. Vaginal fluid will be collected and analyzed and amniotic fluid will also. These tests will be run remotely and not reported to the clinician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Investigator is blinded to results of the analyzer but all patients have samples run on analyzer
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years of age
- •Subject has singleton gestation
- •Subject has fetus with gestational age ≥ 22 0/7 weeks and ≤ 33 6/7 weeks
- •Subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (≥4 per hour) and one or more of the following:
- •Cervical dilation > 2cm
- •Cervical length of ≤25 mm via transvaginal ultrasound
- •Subject has onset of contractions was within 48 hours of enrollment in the study
- •Subject has documented intact amniotic membranes
- •Subject's care provider plans to perform an amniocentesis procedure -
排除标准
- •Subject has documented ruptured amniotic membranes
- •Subject has a fetus with major fetal or genetic anomaly or chromosomal aneuploidy
- •Subject has maternal or fetal indication for preterm birth (e.g., pre-eclampsia)
- •Subject is unable to provide written informed consent
- •Subject has evidence of non-reassuring fetal heart rate tracing requiring immediate delivery
- •Subject has vaginal bleeding within the past 24 hours
- •Subject has advanced labor (cervix >4 cm dilated)
- •Subject has HIV, hepatitis
- •Subject has not been enrolled previously in this study and/or is participating in another study (that in the opinion of the Investigator) may interfere with participation in this study
研究组 & 干预措施
All women eligible to participate
All women presenting who sign the consent and found eligible will have a VF and AF sample taken and analyzed on the Perilynx Analyzer to measure AF and VF fluid. This does not affect their regular standard of care and diagnosis
干预措施: Perilynx Analyzer to measure AF and VF fluid (Diagnostic Test)
结局指标
主要结局
performance of vaginal fluid test
时间窗: 18 months
To assess the performance of a vaginal fluid test for assessing risk of IAI in subjects presenting with preterm labor and intact membranes.
performance of amniocentesis test
时间窗: 18 months
To assess the performance of a rapid amniotic fluid test to identify intraamniotic infection (IAI).
次要结局
未报告次要终点