NCT02576418Unknown不适用
Evaluation of the PartoSure Time to Delivery (TTD) Test to Predict Spontaneous Preterm Delivery in Pregnancies After Assisted Reproductive Technology (ART)
Vietnam National University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The accuracy of c(SN, SP, PPV, NPV) in predicting delivery within 7 or 14 days from testing
研究概览
简要总结
To calculate sensitivity (SN), specificity (SP), positive predictive value (PPV) and negative predictive value (NPV) of PartoSure TTD test in predicting delivery within 7 or 14 days from testing and to compare it with cervical length (CL) measurement by transvaginal ultrasound (15 mm cut-off)
详细描述
- This trial is a prospective observational study.
- Pregnancies after ART between 20 0/7 and 36 6/7 weeks with symptoms of preterm labor, clinically intact membranes, cervical dilatation of ≤ 2 cm will be invited to participate to the study. Signed consent form is required to be able to participate to the study.
- PartoSure and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
- Trial Population:Pregnancies after ART between 20 0/7 and 36 6/7 weeks with symptoms of preterm labor are hospitalized at My Duc hospital from October 2015 to April 2016. The sample size for this trial of 100 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •To be eligible for enrollment into this trial, each female subject must fulfill all of the following criteria at the start of enrollment:
- •Pregnancies after assisted reproductive technology include singleton and twins
- •Between 20 0/7 and 36 6/7 weeks with symptoms of preterm labor including uterine contractions, intermittent lower abdominal pain and pelvic pressure.
- •Clinically intact membranes.
- •Cervical dilatation of ≤ 2 cm
- •Agree to participate in the study, and to disclose any medical events to the investigator
- •Have given written informed consent
排除标准
- •To be eligible for enrollment in this study each subject must not meet any of the following criteria:
- •Vaginal bleeding
- •Overt rupture of the fetal membranes as indicated by visualized leakage of fluid from the cervix
- •Placenta previa
- •Cervical cerclage in place
- •Received tocolytic medications for treatment of threatened preterm delivery prior to collection of the cervicovaginal specimens or CL measurement.
- •Digital exam prior to specimen collection.
- •A symptom not associated with idiopathic threatened preterm delivery (e.g trauma)
- •Enrollment in a tocolytic study.
研究组 & 干预措施
Partosure TTD Test
Experimental
PartoSure TTD test will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
干预措施: Partosure TTD test (Other)
结局指标
主要结局
The accuracy of c(SN, SP, PPV, NPV) in predicting delivery within 7 or 14 days from testing
时间窗: 7 or 14 days from testing
SN, SP, PPV and NPV superiority of PartoSure TTD test compared to CL measurement via transvaginal ultrasound (15 mm cutoff) for the presentation-to-spontaneous-delivery time intervals of ≤ 7 days or 14 days.
次要结局
未报告次要终点
研究者
Manh Tuong Ho
Doctor
Vietnam National University
研究点 (1)
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