Dataset Information

Antenatal antiarrhythmic treatment for fetal tachyarrhythmias: a study protocol for a prospective multicentre trial.

ABSTRACT:

Introduction

Several retrospective or single-centre studies demonstrated the efficacy of transplacental treatment of fetal tachyarrhythmias. Our retrospective nationwide survey showed that the fetal therapy will be successful at an overall rate of 90%. For fetuses with hydrops, the treatment success rate will be 80%. However, standard protocol has not been established. The objective of this study is to evaluate the efficacy and safety of the protocol-defined transplacental treatment of fetal tachyarrhythmias. Participant recruitment began in October 2010.

Methods and analysis

The current study is a multicentre, single-arm interventional study. A total of 50 fetuses will be enrolled from 15 Japanese institutions. The protocol-defined transplacental treatment is performed for singletons with sustained fetal tachyarrhythmia ≥180 bpm, with a diagnosis of supraventricular tachycardia or atrial flutter. Digoxin, sotalol, flecainide or a combination is used for transplacental treatment. The primary endpoint is disappearance of fetal tachyarrhythmias. The secondary endpoints are fetal death related to tachyarrhythmia, proportion of preterm birth, rate of caesarean section attributable to fetal arrhythmia, improvement in fetal hydrops, neonatal arrhythmia, neonatal central nervous system disorders and neonatal survival. Maternal, fetal and neonatal adverse events are evaluated at 1 month after birth. Growth and development are also evaluated at 18 and 36 months of corrected age.

Ethics and dissemination

The Institutional Review Board of the National Cerebral and Cardiovascular Center of Japan has approved this study. Our findings will be widely disseminated through conference presentations and peer-reviewed publications.

Trial registration number

UMIN Clinical Trials Registry UMIN000004270.

SUBMITTER: Miyoshi T

PROVIDER: S-EPMC5629695 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Publications

Antenatal antiarrhythmic treatment for fetal tachyarrhythmias: a study protocol for a prospective multicentre trial.

Miyoshi Takekazu T Maeno Yasuki Y Sago Haruhiko H Inamura Noboru N Yasukochi Satoshi S Kawataki Motoyoshi M Horigome Hitoshi H Yoda Hitoshi H Taketazu Mio M Shozu Makio M Nii Masaki M Hagiwara Akiko A Kato Hitoshi H Shimizu Wataru W Shiraishi Isao I Sakaguchi Heima H Ueda Keiko K Katsuragi Shinji S Ikeda Tomoaki T Yamamoto Haruko H Hamasaki Toshimitsu T

BMJ open 20170829 8

<h4>Introduction</h4>Several retrospective or single-centre studies demonstrated the efficacy of transplacental treatment of fetal tachyarrhythmias. Our retrospective nationwide survey showed that the fetal therapy will be successful at an overall rate of 90%. For fetuses with hydrops, the treatment success rate will be 80%. However, standard protocol has not been established. The objective of this study is to evaluate the efficacy and safety of the protocol-defined transplacental treatment of f ...[more]

PMID: 28851790

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Dataset Information

Antenatal antiarrhythmic treatment for fetal tachyarrhythmias: a study protocol for a prospective multicentre trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Antenatal antiarrhythmic treatment for fetal tachyarrhythmias: a study protocol for a prospective multicentre trial.

Similar Datasets

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