Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension? - HOTPOT

Royal College of Surgeons in Ireland0 个研究点目标入组 60 人开始时间: 2016年8月11日最近更新: 2018年11月12日

适应症

试验速览

暂无简介。

•The inclusion criteria can be divided into 3 main categories:
•A)Those at risk of respiratory morbidity at term
•Iatrogenic elective Caesarean section being performed < 38 gestational weeks in an otherwise well baby. This subgroup will be informative in relation to circulatory adaptation close to term.
•B)Those at risk of pulmonary hypoplasia
•Patients with mid trimester PPROM
•Patients with persistent oligohydramnios of renal or nonrenal origin
•Patients whose fetuses have known: Congenital diaphragmatic hernia (CDH), Congenital cystic adenomatoid malformation (CCAM)
•Other space occupying lesions of the thorax (cardiomegaly, pleural effusion and skeletal dysplasia).
•C)Those at risk of respiratory morbidity due to a cardiac cause
•Women whose fetuses have a prenatal diagnosis of moderate/severe perimembranous ventricular septal defect (VSD)/atrioventricular septal defect (AVSD) in the absence of other structural heart disease including cases of Trisomy 21. The MH test may contribute to prediction of the need for neonatal intervention in this group.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•The exclusion criteria are as follows:
•Maternal age < 18 years
•Known fetal chromosomal abnormality excluding Trisomy 21
•Gestational age <31 weeks and >40 weeks
•Maternal chronic respiratory disease (including COPD, Cystic Fibrosis, Pulmonary Fibrosis)
•Maternal congenital heart disease
•Maternal use of bleomycin or amiodarone
•The justification for the exclusion criteria are as follows:
•An adult is defined as a person aged 18 years or over.
•The literature indicates that maternal hyperoxygenation does not alter fetal pulmonary circulation until after 31 weeks and therefore we will perform the test after 31 weeks gestation.
•The use of high flow oxygen is contraindicated in patients with chronic respiratory disease.
•Pregnant women with congenital heart disease are high risk antenatal patients and will be excluded to avoid them being exposed to high flow oxygen and to avoid any misinterpretation of the NICOM.
•High flow oxygen should be avoided in any person taking the medications bleomycin or amiodarone.

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