(2019) Levothyroxine in women with thyroid peroxidase antibodies before conception. New England Journal Of Medicine , 380 (14). pp. 1316-1325. doi:10.1056/NEJMoa1812537

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Abstract

BACKGROUND
Thyroid peroxidase antibodies are associated with an increased risk of miscarriage and preterm birth, even when thyroid function is normal. Small trials indicate that the use of levothyroxine could reduce the incidence of such adverse outcomes.

METHODS
We conducted a double-blind, placebo-controlled trial to investigate whether levothyroxine treatment would increase live-birth rates among euthyroid women who had thyroid peroxidase antibodies and a history of miscarriage or infertility. A total of 19,585 women from 49 hospitals in the United Kingdom underwent testing for thyroid peroxidase antibodies and thyroid function. We randomly assigned 952 women to receive either 50 μg once daily of levothyroxine (476 women) or placebo (476 women) before conception through the end of pregnancy. The primary outcome was live birth after at least 34 weeks of gestation.

RESULTS
The follow-up rate for the primary outcome was 98.7% (940 of 952 women). A total of 266 of 470 women in the levothyroxine group (56.6%) and 274 of 470 women in the placebo group (58.3%) became pregnant. The live-birth rate was 37.4% (176 of 470 women) in the levothyroxine group and 37.9% (178 of 470 women) in the placebo group (relative risk, 0.97; 95% confidence interval [CI], 0.83 to 1.14, P=0.74; absolute difference, −0.4 percentage points; 95% CI, −6.6 to 5.8). There were no significant between-group differences in other pregnancy outcomes, including pregnancy loss or preterm birth, or in neonatal outcomes. Serious adverse events occurred in 5.9% of women in the levothyroxine group and 3.8% in the placebo group (P=0.14).

CONCLUSIONS
The use of levothyroxine in euthyroid women with thyroid peroxidase antibodies did not result in a higher rate of live births than placebo. (Funded by the United Kingdom National Institute for Health Research; TABLET Current Controlled Trials number, ISRCTN15948785. opens in new tab.)

Item Type:	Journal Article
Subjects:	R Medicine > RG Gynecology and obstetrics
Divisions:	Faculty of Medicine > Warwick Medical School > Biomedical Sciences > Cell & Developmental Biology Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Thyroid gland -- Diseases, Miscarriage , Thyroid gland diseases in pregnancy
Journal or Publication Title:	New England Journal Of Medicine
Publisher:	Massachusetts Medical Society
ISSN:	0028-4793
Official Date:	4 April 2019
Dates:	Date Event 4 April 2019 Published 23 March 2019 Available 23 March 2019 Accepted
Date of first compliant deposit:	2 December 2019
Volume:	380
Number:	14
Page Range:	pp. 1316-1325
DOI:	10.1056/NEJMoa1812537
Status:	Peer Reviewed
Publication Status:	Published
Publisher Statement:	“From Dhillon-Smith, Rima K., Middleton, Lee J., Sunner, Kirandeep K., Cheed, Versha, Baker, Krys, Farrell-Carver, Samantha, Bender-Atik, Ruth, Agrawal, Rina, Bhatia, Kalsang, Edi-Osagie, Edmond et al. (2019) Levothyroxine in women with thyroid peroxidase antibodies before conception. New England Journal Of Medicine , 380 (14). pp. 1316-1325 Copyright © 2019 Massachusetts Medical Society. Reprinted with permission.
Access rights to Published version:	Restricted or Subscription Access
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID UNSPECIFIED [NIHR] National Institute for Health Research http://dx.doi.org/10.13039/501100000272

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