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; null H R Verhoeve; null H C J Scheepers; S Rombout-de Weerd; C Koks; J J Zwart; F Broekmans; W Verpoest; O Christiansen; null M Post; D N M Papatsonis; M F G Verberg; J Sikkema; B W Mol; P H Bisschop; M Goddijn

doi:10.1016/j.cct.2015.08.005

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

28 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.

Originalsprog	Engelsk
Tidsskrift	Contemporary Clinical Trials
Vol/bind	44
Sider (fra-til)	134–138
ISSN	1551-7144
DOI	https://doi.org/10.1016/j.cct.2015.08.005
Status	Udgivet - 5 aug. 2015

Adgang til dokumentet

10.1016/j.cct.2015.08.005

Citationsformater

Vissenberg, R., van Dijk, M. M., Fliers, E., van der Post, J. A. M., van Wely, M., Bloemenkamp, K. W. M., Hoek, A., Kuchenbecker, W. K., H R Verhoeve, H C J Scheepers, Rombout-de Weerd, S., Koks, C., Zwart, J. J., Broekmans, F., Verpoest, W., Christiansen, O., M Post, Papatsonis, D. N. M., Verberg, M. F. G., ... Goddijn, M. (2015). Effect of levothyroxine on live birth rate in euthyroid women with recurrent miscarriage and TPO antibodies (T4-LIFE study). Contemporary Clinical Trials, 44 , 134–138. https://doi.org/10.1016/j.cct.2015.08.005

Vissenberg, R, van Dijk, MM, Fliers, E, van der Post, JAM, van Wely, M, Bloemenkamp, KWM, Hoek, A, Kuchenbecker, WK, H R Verhoeve, H C J Scheepers, Rombout-de Weerd, S, Koks, C, Zwart, JJ, Broekmans, F, Verpoest, W, Christiansen, O, M Post, Papatsonis, DNM, Verberg, MFG, Sikkema, J, Mol, BW, Bisschop, PH & Goddijn, M 2015, 'Effect of levothyroxine on live birth rate in euthyroid women with recurrent miscarriage and TPO antibodies (T4-LIFE study)', Contemporary Clinical Trials, bind 44 , s. 134–138. https://doi.org/10.1016/j.cct.2015.08.005

@article{260d4dcc9ce54d6cb6e7349149bfc7eb,

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

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.",

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

note = "Copyright {\textcopyright} 2015. Published by Elsevier Inc.",

year = "2015",

month = aug,

day = "5",

doi = "10.1016/j.cct.2015.08.005",

language = "English",

volume = "44 ",

pages = "134–138",

journal = "Contemporary Clinical Trials",

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TY - JOUR

T1 - Effect of levothyroxine on live birth rate in euthyroid women with recurrent miscarriage and TPO antibodies (T4-LIFE study)

AU - Vissenberg, R

AU - van Dijk, M M

AU - Fliers, E

AU - van der Post, J A M

AU - van Wely, M

AU - Bloemenkamp, K W M

AU - Hoek, A

AU - Kuchenbecker, W K

AU - H R Verhoeve, null

AU - H C J Scheepers, null

AU - Rombout-de Weerd, S

AU - Koks, C

AU - Zwart, J J

AU - Broekmans, F

AU - Verpoest, W

AU - Christiansen, O

AU - M Post, null

AU - Papatsonis, D N M

AU - Verberg, M F G

AU - Sikkema, J

AU - Mol, B W

AU - Bisschop, P H

AU - Goddijn, M

PY - 2015/8/5

Y1 - 2015/8/5

N2 - 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.

AB - 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.

U2 - 10.1016/j.cct.2015.08.005

DO - 10.1016/j.cct.2015.08.005

M3 - Journal article

C2 - 26255238

SN - 1551-7144

VL - 44

SP - 134

EP - 138

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

ER -

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

Abstract

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