Fetal Atrial Flutter & Supraventricular Tachycardia (FAST) Therapy Trial - Fetal Atrial Flutter & Supraventricular Tachycardia Therapy Trial

St Georges University Hospital NHS Foundation Trust0 个研究点目标入组 600 人开始时间: 2016年3月1日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•1) Mother has provided written informed consent to participate in the RCT
•2) One of the following conditions: Fetal AF without hydrops (RCT A) or SVT without hydrops (RCT B) or SVT with hydrops (RCT C)
•3) Tachyarrhythmia that is significant enough to justify immediate transplacental pharmacological treatment:
•a) Tachycardia = 170 bpm during 100% of observation time of at least 30 minutes and gestational age <30 weeks
•b) Tachycardia = 180 bpm during at least 10% of observation time of 30 minutes or longer
•c) Tachycardia = 280 bpm, irrespective of SVA duration
•d) Tachycardia with fetal hydrops, irrespective of SVA duration
•4) Gestational age <37 0/7 weeks at time of enrollment
•5) Untreated at time of enrollment
•6) Singleton Pregnancy
•7) Healthy mother with ± normal baseline findings including:
•a) ECG without significant abnormalities (sinus rhythm; QTc = 0.47; PR = 0.2 sec; QRS: = 0.12 sec; isolated PACs or PVCs or isolated complete right bundle branch block allowed)
•b) Resting heart rate = 50 bpm
•c) Systolic BP = 85 mmHg
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 600
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1) Fetal AF with hydrops (condition is too infrequent to be studied in a separate RCT)
•2) Any maternal-fetal conditions associated with high odds of premature delivery and/or death (e.g. severe IUGR; premature rupture of membrane; life-threatening maternal disease (incl. pre-eclampsia; HELLP syndrome); severe congenital fetal abnormalities (T 13 or 18; surgery or death expected < 1 month))
•3) Any relevant preexisting maternal heart condition (open heart surgery; sick sinus syndrome; long QT, Brugada syndrome; ventricular tachycardia; WPW syndrome; high-degree heart block; cardiomyopathy)
•4) Relevant preexisting maternal obstructive airway disease including asthma
•5) Maternal history of chronic substance abuse
•6) Maternal intake of QT-prolonging medication
•7) Maternal serum potassium level <3.3 mEq/L (at start of treatment)
•8) Maternal ionized serum calcium level of <1 mmol/l (at start of treatment)
•9) Maternal serum creatinine level >1.1 mg/dl

发起方

St Georges University Hospital NHS Foundation Trust