A Novel Technique for Prediction of Preterm Birth: Fetal Breathing Patterns
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
- 否
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
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
Sertac Esin
Associate Professor
Baskent University Ankara Hospital
