Evidence map›Paper›PMID 24963627›Full record

ArticlePloS one2014

First trimester exposure to anxiolytic and hypnotic drugs and the risks of major congenital anomalies: a United Kingdom population-based cohort study.

Lu Ban, Joe West, Jack E Gibson, Linda Fiaschi, Rachel Sokal, Pat Doyle, Richard Hubbard, Liam Smeeth, Laila J Tata

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
7.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 91 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 1 country.

Lu BanDivision of Epidemiology & Public Health, Nottingham City Hospital, University of Nottingham, Nottingham, United Kingdom.
Joe WestDivision of Epidemiology & Public Health, Nottingham City Hospital, University of Nottingham, Nottingham, United Kingdom.
Jack E GibsonDivision of Epidemiology & Public Health, Nottingham City Hospital, University of Nottingham, Nottingham, United Kingdom.
Linda FiaschiDivision of Epidemiology & Public Health, Nottingham City Hospital, University of Nottingham, Nottingham, United Kingdom.
Rachel SokalDivision of Epidemiology & Public Health, Nottingham City Hospital, University of Nottingham, Nottingham, United Kingdom.
Pat DoyleDepartment of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Richard HubbardDivision of Epidemiology & Public Health, Nottingham City Hospital, University of Nottingham, Nottingham, United Kingdom.
Liam SmeethDepartment of Non-communicable Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.
Laila J TataDivision of Epidemiology & Public Health, Nottingham City Hospital, University of Nottingham, Nottingham, United Kingdom.
Nottingham City Hospital · GBLondon School of Hygiene & Tropical Medicine · GBUniversity of Nottingham · GB

Funding

Medical Research Council MR/K006584/1Wellcome Trust 098504
6 · The paper itself

Abstract

backgroundDespite their widespread use the effects of taking benzodiazepines and non-benzodiazepine hypnotics during pregnancy on the risk of major congenital anomaly (MCA) are uncertain. The objectives were to estimate absolute and relative risks of MCAs in children exposed to specific anxiolytic and hypnotic drugs taken in the first trimester of pregnancy, compared with children of mothers with depression and/or anxiety but not treated with medication and children of mothers without diagnosed mental illness during pregnancy.

methodsWe identified singleton children born to women aged 15-45 years between 1990 and 2010 from a large United Kingdom primary care database. We calculated absolute risks of MCAs for children with first trimester exposures of different anxiolytic and hypnotic drugs and used logistic regression with a generalised estimating equation to compare risks adjusted for year of childbirth, maternal age, smoking, body mass index, and socioeconomic status.

resultsOverall MCA prevalence was 2.7% in 1,159 children of mothers prescribed diazepam, 2.9% in 379 children with temazepam, 2.5% in 406 children with zopiclone, and 2.7% in 19,193 children whose mothers had diagnosed depression and/or anxiety but no first trimester drug exposures. When compared with 2.7% in 351,785 children with no diagnosed depression/anxiety nor medication use, the adjusted odds ratios were 1.02 (99% confidence interval 0.63-1.64) for diazepam, 1.07 (0.49-2.37) for temazepam, 0.96 (0.42-2.20) for zopiclone and 1.27 (0.43-3.75) for other anxiolytic/hypnotic drugs and 1.01 (0.90-1.14) for un-medicated depression/anxiety. Risks of system-specific MCAs were generally similar in children exposed and not exposed to such medications.

conclusionsWe found no evidence for an increase in MCAs in children exposed to benzodiazepines and non-benzodiazepine hypnotics in the first trimester of pregnancy. These findings suggest that prescription of these drugs during early pregnancy may be safe in terms of MCA risk, but findings from other studies are required before safety can be confirmed.

Indexed as

Abnormalities, Drug-InducedAdolescentAdultAnti-Anxiety AgentsAnxietyBenzodiazepinesChildCohort StudiesDepressionFemaleFollow-Up StudiesHumansHypnotics and SedativesInfant, NewbornMaleMiddle AgedAnti-Anxiety AgentsBenzodiazepinesHypnotics and Sedatives

Identifiers

PMID24963627
PMCPMC4071000
OpenAlexW2025396655

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.