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临床试验/NCT03655379
NCT03655379已完成不适用

A Novel Technique for Prediction of Preterm Birth: Fetal Breathing Patterns

Baskent University Ankara Hospital2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
2
主要终点
Inspiration Duration

研究概览

简要总结

Preterm birth refers to a delivery that occurs before 37 weeks of gestation. Identification of those who will eventually deliver in the preterm period is very important. However, few interventions have been proven to prolong pregnancy in women at risk such as cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements. In a meta-analysis comparing fetal breathing with cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements, absence of fetal breathing was superior to other methods for prediction of preterm birth in 48 hours or 7 days. In this study, the investigators hypothesized that if a fetus holds its breath in case of preterm birth, then there may be specific fetal breathing patterns during preterm labor, which may be detected by ultrasonography

详细描述

Preterm birth refers to a delivery that occurs before 37 weeks of gestation and it is the leading cause of neonatal morbidity and mortality. 33% of prenatal hospital admissions are due to preterm labor but almost 50% of patients receiving tocolytics in order to prevent birth deliver in the term period. Therefore, identification of those who will eventually deliver in the preterm period is very important. Ideally, identification of modifiable and nonmodifiable risk factors for preterm birth in will lead to interventions that help prevent this complication. However, few interventions have been proven to prolong pregnancy in women at risk such as cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements. Another method for preterm birth prediction is presence of fetal breathing. In a meta-analysis comparing fetal breathing with cervicovaginal fetal fibronectin (fFN) level or transvaginal cervical length measurements, absence of fetal breathing was superior to other methods for prediction of preterm birth in 48 hours or 7 days. In this study, the investigators hypothesized that if a fetus holds its breath in case of preterm birth, then there may be specific fetal breathing patterns during preterm labor, which may be detected by ultrasonography

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant patients between 24-37 gestational weeks with preterm labor : Uterine contractions ≥4 in number in 20 minutes or ≥ 8 in number in 60 minutes and one of the following:
  • Cervical dilation ≥ 3 cm
  • Transvaginal cervical length <20mm

排除标准

  • Multifetal pregnancy
  • Cervical dilation > 5 cm
  • Heavy vaginal bleeding
  • Non-reassuring fetal non-stress test
  • Preterm premature rupture of membranes
  • Intrauterine growth restriction
  • Oligohydramniosis
  • Fetal anomaly
  • Patients who received tocolytics for preterm labor or corticosteroids for lung maturation
  • Drug or substance use which may depress fetal breathing

研究组 & 干预措施

Nasal Doppler

Experimental

Pregnant patients who present with preterm labor will be evaluated with ultrasonography and fetal nasal Doppler will be used to detect specific fetal breathing patterns

干预措施: Fetal nasal Doppler by ultrasonography (Device)

结局指标

主要结局

Inspiration Duration

时间窗: Admission ultrasonography

Fetal Inspiration Duration

Expiration Duration

时间窗: Admission ultrasonography

Fetal Expiration Duration

次要结局

未报告次要终点

研究者

发起方
Baskent University Ankara Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sertac Esin

Associate Professor

Baskent University Ankara Hospital

研究点 (2)

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