TADAFER II: Tadalafil treatment for fetal growth restriction - a study protocol for a multicenter randomised controlled phase II trial.

ABSTRACT:

Introduction

There is no proven therapy to reverse or ameliorate fetal growth restriction (FGR). Sildenafil, a selective phosphodiesterase 5 (PDE5) inhibitor, has been reported to potentially play a therapeutic role in FGR, but this has not been established. Tadalafil is also a selective PDE5 inhibitor. We have demonstrated the efficacy of tadalafil against FGR along with short-term outcomes and the feasibility of tadalafil treatment. Based on the hypothesis that tadalafil will safely increase the likelihood of increased fetal growth in FGR, we designed this phase II study to prospectively evaluate the efficacy and safety of tadalafil against FGR.

Methods and analysis

This study is a multicentre, randomised controlled phase II trial. A total of 140 fetuses with FGR will be e

SUBMITTER: Umekawa T 

PROVIDER: S-EPMC6224767 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature