Valacyclovir to Prevent Vertical Transmission of Cytomegalovirus After Maternal Primary Infection During Pregnancy

Summary

The purpose of this study is to determine whether Valacyclovir treatment, administered during pregnancy after proven primary maternal Cytomegalovirus (CMV) infection, reduces fetal transmission rates and prevents fetal injury in cases of fetal infection.

Timeline

Start

2015-11

Primary completion

2019-07

Completion

2019-07

Publications

• Background Buonsenso D, Serranti D, Gargiullo L, Ceccarelli M, Ranno O, Valentini P. Congenital cytomegalovirus infection: current strategies and future perspectives. Eur Rev Med Pharmacol Sci. 2012 Jul;16(7):919-35.
• Background Gaytant MA, Steegers EA, Semmekrot BA, Merkus HM, Galama JM. Congenital cytomegalovirus infection: review of the epidemiology and outcome. Obstet Gynecol Surv. 2002 Apr;57(4):245-56. doi: 10.1097/00006254-200204000-00024.
• Background Ornoy A, Diav-Citrin O. Fetal effects of primary and secondary cytomegalovirus infection in pregnancy. Reprod Toxicol. 2006 May;21(4):399-409. doi: 10.1016/j.reprotox.2005.02.002.
• Background Bodeus M, Kabamba-Mukadi B, Zech F, Hubinont C, Bernard P, Goubau P. Human cytomegalovirus in utero transmission: follow-up of 524 maternal seroconversions. J Clin Virol. 2010 Feb;47(2):201-2. doi: 10.1016/j.jcv.2009.11.009. Epub 2009 Dec 16. No abstract available.
• Results Jacquemard F, Yamamoto M, Costa JM, Romand S, Jaqz-Aigrain E, Dejean A, Daffos F, Ville Y. Maternal administration of valaciclovir in symptomatic intrauterine cytomegalovirus infection. BJOG. 2007 Sep;114(9):1113-21. doi: 10.1111/j.1471-0528.2007.01308.x. Epub 2007 Jul 6.
• Shahar-Nissan K, Pardo J, Peled O, Krause I, Bilavsky E, Wiznitzer A, Hadar E, Amir J. Valaciclovir to prevent vertical transmission of cytomegalovirus after maternal primary infection during pregnancy: a randomised, double-blind, placebo-controlled trial. Lancet. 2020 Sep 12;396(10253):779-785. doi: 10.1016/S0140-6736(20)31868-7.

Drugs

Indications