The clinical trial of tadalafil treatment for fetus with early-onset growth restriction placebo-controlled ramdomized multicenter phase II trial- - TADAFER IIb

Maki Shintaro0 个研究点目标入组 180 人开始时间: 2019年9月2日最近更新: 2024年5月27日

适应症

试验速览

暂无简介。

•1)Age 20 - 44
•2)Estimated fetal weight (EFW) less than 1.5 standard deviations of the mean EFW for gestational age.
•3)Gestational age between 20 + 0 and 31 + 6 weeks.
•4)The expected date of confinement is determined using the criteria of the guidelines for obstetrical practice in Japan (2017).
•5)Singleton pregnancy
•6)Written informed consent.

•1)A result from antepartum fetal tests consisted of ultrasonography including Doppler imaging and fetal heart rate monitoring at eligibility indicates that delivery should be attempted.
•2)A history of allergy to tadalafil
•3)Concurrent medications that interact adversely with tadalafil
•4)Relative contraindication of tadalafil treatment due to renal disease.
•5)Relative contraindication of tadalafil treatment due to liver disease.
•6)Relative contraindication of tadalafil treatment due to uncontrolled arrhythmia, hypertension (BP >170/110 mmHg), and hypotension (BP <80/40 mmHg).
•7)Fetus with suspected chromosomal disorder and/or multiple congenital anomalies.
•8)Relative contraindication of tadalafil treatment due to retinitis pigmentosa, coagulation defect, active gastric and/or intestinal ulcer, and venous obstructive disease.
•9)Attending physician decides to entry inappropriate.

发起方

Maki Shintaro