Effect of levothyroxine on live birth rate in euthyroid women with recurrent miscarriage and TPO antibodies (T4-LIFE study)

R Vissenberg, M M van Dijk, E Fliers, J A M van der Post, M van Wely, K W M Bloemenkamp, A Hoek, W K Kuchenbecker, H R Verhoeve, H C J Scheepers, S Rombout-de Weerd, C Koks, J J Zwart, F Broekmans, W Verpoest, O Christiansen, M Post, D N M Papatsonis, M F G Verberg, J SikkemaB W Mol, P H Bisschop, M Goddijn

    27 Citationer (Scopus)

    Abstract

    BACKGROUND: Thyroid peroxidase antibodies (TPO-Ab) in euthyroid women are associated with recurrent miscarriage (RM) and other pregnancy complications such as preterm birth. It is unclear if treatment with levothyroxine improves pregnancy outcome. Aim To determine the effect of levothyroxine administration on live birth rate in euthyroid TPO-Ab positive women with recurrent miscarriage.

    METHODS: /Design We will perform a multicenter, placebo controlled randomized trial in euthyroid women with recurrent miscarriage and TPO-Ab. Recurrent miscarriage is defined as two or more miscarriages before the 20th week of gestation. The primary outcome is live birth, defined as the birth of a living fetus beyond 24weeks of gestation. Secondary outcomes are ongoing pregnancy at 12weeks, miscarriage, preterm birth, (serious) adverse events, time to pregnancy and survival at 28days of neonatal life. The analysis will be performed according to the intention to treat principle. We need to randomize 240 women (120 per group) to demonstrate an improvement in live birth rate from 55% in the placebo group to 75% in the levothyroxine treatment group. This trial is a registered trial (NTR 3364, March 2012). Here we discuss the rationale and design of the T4-LIFE study, an international multi-center randomized, double blind placebo controlled, clinical trial aimed to assess the effectiveness of levothyroxine in women with recurrent miscarriage and TPO-Ab.

    OriginalsprogEngelsk
    TidsskriftContemporary Clinical Trials
    Vol/bind44
    Sider (fra-til)134–138
    ISSN1551-7144
    DOI
    StatusUdgivet - 5 aug. 2015

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