Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Fetal cardiac ejection fraction
研究概览
简要总结
The goal of this observational study is to learn about cardiac function and remodelling and metabolomic profiles in fetuses and infants who were exposed to a threatened preterm labor (TPL) during pregnancy.
详细描述
The main questions it aims to answer are:
- Evaluate the impact of threated preterm labour in cardiovascular and metabolic programming in fetal life and early infancy.
- Describe prenatal and postnatal patterns of cardiac remodelling associated to threatened preterm labour.
- Describe fetal growth patterns associated to threatened preterm labour.
- Describe metabolomic profiles in umbilical cord blood associated to cardiovascular programming in fetuses exposed to threatened preterm labour.
The study's main tasks are:
- To perform an antenatal echocardiography of the exposed cohort is performed during the admission due to TPL or preterm spontaneous rupture of membranes (SRM).
- All participants are asked to fill a diet and stress questionnaire.
- To collect cord blood at the time of delivery.
- To perform a postnatal echocardiography six months after birth.
Researchers will compare fetuses and infants who were exposed to TPL to those who were not exposed to TPL during pregnancy to see if threre are any differences in cardiac function and remodelling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Singleton pregnancies.
- •Study patients must be 18 years or older
- •Good understanding of Spanish
排除标准
- •Multiple pregnancies
- •Major fetal defects or anomalies
- •Underlying process that can cause a preterm labour
- •Iatrogenic preterm labour
结局指标
主要结局
Fetal cardiac ejection fraction
时间窗: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Fetal cardiac E/A ratios
时间窗: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Infant global cardiac longitudinal strain rate
时间窗: 6 months
Using echocardiography in order to measure myocardial function
ProBNP, troponin and cystatin levels in cord blood
时间窗: Third stage of labor
Electrochemiluminescence immunoassay
Infant cardiac strain rate imaging
时间窗: 6 months
Using echocardiography in order to measure myocardial function
Fetal cardiac sphericity index
时间窗: 24 - 36+6 weeks of gestation
2-D mode
Fetal cardiac debit
时间窗: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Fetal cardiac diameters
时间窗: 24 - 36+6 weeks of gestation
Measurement of atrial and ventricular longitudinal and transverse diameters with 2-D mode
Fetal ventricular and atrial areas
时间窗: 24 - 36+6 weeks of gestation
2-D mode
Fetal mitral and tricuspid annular plane systolic excursion (MAPSE and TAPSE)
时间窗: 24 - 36+6 weeks of gestation
M-mode
Fetal cardiac isovolumetric relaxation time
时间窗: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Estimated left ventricular myocardial mass
时间窗: 6 months
2D echochardiography
Left ventricular end-diastolic volume
时间窗: 6 months
2D echochardiography
Left ventricular ejection fraction
时间窗: 6 months
2D echochardiography
Fetal cardiac ejection volume
时间窗: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Fetal cardiac filling and ejection time fractions
时间窗: 24 - 36+6 weeks of gestation
Pulsed-Doppler
Fetal Doppler
时间窗: 24 - 36+6 weeks of gestation
Measurement of umbilical artery pulsatility index (PI), medial cerebral artery PI and systolic peak (SP), ductus venosus PI, and mean uterine arteries PI using pulsed-Doppler
Fetal growth
时间窗: 24 - 36+6 weeks of gestation
Hadlock formula
Left ventricular muscle index
时间窗: 6 months
2D echochardiography
次要结局
- Adherence to Mediterranean diet(24 - 36+6 weeks of gestation)
- Maternal stress levels(24 - 36+6 weeks of gestation)
- Maternal anxiety levels(24 - 36+6 weeks of gestation)
研究者
Cristina Paules
Principal Investigator
Instituto de Investigación Sanitaria Aragón