Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
研究概览
简要总结
Currently, the American College of Obstetricians and Gynecologists (ACOG) indicate in their most recent Practice Bulletin on the Management of Preterm Labor that many tests to identify women at risk of preterm birth have been proposed and evaluated; however, only ultrasonography and fetal fibronectin testing have been shown to have benefit. Ultrasonography to determine cervical length, fetal fibronectin testing, or a combination of both may be useful in determining which women are at high risk for preterm delivery. However, their clinical usefulness may rest primarily with their ability to identify women who are least likely to deliver (i.e. their negative predictive value). Therefore, there is an urgent need for a test with a high positive predictive value in order to accurately predict imminent delivery to allow for salutary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Patients presenting for emergency obstetrical care at an emergency room or labor & delivery unit with signs, symptoms or complaints suggestive of preterm labor (PTL)
- •Uterine contractions, with or without pain
- •Intermittent lower abdominal pain
- •Dull backache
- •Pelvic pressure
- •Bleeding during the second or third trimester
- •Menstrual-like or intestinal cramping, with or without diarrhea
- •Patient is not "feeling right"
- •Gestational age between 200/7 and 366/7
- •Consenting to be part of the trial
排除标准
- •Presented for regularly scheduled obstetrical care with symptoms
- •< 18 years old and not emancipated consenting minor
- •< 200/7 weeks of gestation or ≥ 37 weeks of gestation cervix length > 30 mm
- •cervical dilatation > 3 centimeters
- •overt rupture of the fetal membranes (ROM) as indicated by visualized leakage of fluid from the cervical os
- •heavy vaginal bleeding
- •received tocolytic medications for treatment of threatened preterm delivery prior to collection of the cervicovaginal specimens or cervical length measurements
- •suspected placenta previa
- •cervical cerclage in place
- •a symptom not associated with idiopathic threatened preterm delivery (e.g. trauma)
- •digital exam prior to specimen collection
研究组 & 干预措施
PartoSure
Use of PartoSure to determine the risk of preterm birth
干预措施: PartoSure (Device)
Fetal Fibronectine (fFn)
Use of fFn to determine the risk of preterm birth
干预措施: Fetal Fibronectine (Device)
结局指标
主要结局
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
时间窗: 14 days
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) for the kit for the detection of PAMG-1, cervical length measurements by trans-vaginal ultrasound (\<30 mm), and contraction frequency ≥ 8 per hour.
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
时间窗: 48 hours
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) for the kit for the detection of PAMG-1, cervical length measurements by trans-vaginal ultrasound (\<30 mm), and contraction frequency ≥ 8 per hour.
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value
时间窗: 7 days
Sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) for the kit for the detection of PAMG-1, cervical length measurements by trans-vaginal ultrasound (\<30 mm), and contraction frequency ≥ 8 per hour.
次要结局
未报告次要终点
研究者
Caroline Van Holsbeke
Principal investigator
Ziekenhuis Oost-Limburg