Evidence map›Paper›PMID 29478010›Full record

ArticleBMJ open2018

Insulin analogues use in pregnancy among women with pregestational diabetes mellitus and risk of congenital anomaly: a retrospective population-based cohort study.

Hao Wang, Ewa Wender-Ozegowska, Ester Garne, Margery Morgan, Maria Loane, Joan K Morris, Marian K Bakker, Miriam Gatt, Hermien de Walle, Susan Jordan and 6 more

Open access · goldAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Effectiveness of Insulin Analogs Compared with Human Insulins in Pregnant Women with Diabetes Mellitus: Systematic Review and Meta-analysis.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2019
    Pooled it
  2. Article
  3. Review
  4. Pregestational Diabetes and Congenital Heart Defects.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2022
    Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
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

16 authors at 11 institutions in 7 countries.

Hao WangPharmacoepidemiology and Pharmacoeconomics, University of Groningen, Groningen, The Netherlands.
Ewa Wender-OzegowskaDivision of Reproduction, Poznan University of Medical Sciences, Poznan, Poland.
Ester GarnePaediatric Department, Hospital Lillebaelt, Kolding, Denmark.
Margery MorganObstetrician & Gynaecologist, Singleton Hospital, Swansea, UK.
Maria LoaneSchool of Nursing, Ulster University, Northern Ireland, UK.
Joan K MorrisQueen Mary University of London, London, UK.
Marian K BakkerFaculty of Medical Science, University Medical Centre Groningen, Groningen, The Netherlands.
Miriam GattDepartment of Health Information and Research, Ministry of Health, Valletta, Malta.
Hermien de WalleFaculty of Medical Science, University Medical Centre Groningen, Groningen, The Netherlands.
Susan JordanSchool of Nursing, Swansea University, Swansea, UK.
Anna Materna-KirylukDepartment of Medical Genetics, Poznan University of Medical Sciences, Poznan, Poland.
Vera NelenProvinciaal Instituut voor Hygiene, Antwerp, Belgium.
Guy ThysProvinciaal Instituut voor Hygiene, Antwerp, Belgium.
Awi WieselBirth Registry Mainz Model, Children's Hospital, University Medical Center of Mainz, Mainz, Germany.
Helen DolkUlster University, Northern Ireland, UK.
Lolkje T W de Jong-van den BergPharmacoepidemiology and Pharmacoeconomics, University of Groningen, Groningen, The Netherlands.
Poznan University of Medical Sciences · PLProvincial Institute for Hygiene · BEUniversity Medical Center Groningen · NLUniversity of Groningen · NLUniversity of Ulster · GBLillebaelt Hospital · DKMinistry for Health · MTQueen Mary University of London · GBSingleton Hospital · GBSwansea University · GBUniversity Medical Center of the Johannes Gutenberg University Mainz · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the risk of major congenital anomaly associated with first-trimester exposure to insulin analogues compared with human insulin in offspring of women with pregestational diabetes. DESIGN AND

settingA population-based cohort of women with pregestational diabetes (n=1661) who delivered between 1996 and 2012 was established retrospectively from seven European regions covered bythe European Surveillance of Congenital Anomalies (EUROCAT) congenital anomaly registries. PRIMARY OUTCOME MEASURES: The risk of non-chromosomal major congenital anomaly in live births, fetal deaths and terminations for a fetal anomaly exposed to insulin analogues in the first trimester of pregnancy was compared with the risk in those exposed to human insulin only.

resultsDuring the first trimester, 870 fetuses (52.4%) were exposed to human insulin only, 397 fetuses (23.9%) to insulin analogues only and 394 fetuses (23.7%) to both human insulin and insulin analogues. The risk of major congenital anomaly in fetuses exposed to insulin analogues only was lower than those exposed to human insulin only; the relative risk adjusted for glycaemic control and region was 0.56 (95% CI 0.29 to 1.06). The significantly lower risk related to exposure of insulin analogues only was observed in congenital heart defects: adjusted relative risk 0.14 (95% CI 0.03 to 0.62).

conclusionsIn this retrospective population-based cohort study across Europe, first-trimester exposure to insulin analogues did not increase the risk of major congenital anomaly compared with exposure to human insulin. A possible lower risk of congenital heart defects among fetuses exposed to insulin analogues only deserves further investigation.

Indexed as

Abnormalities, Drug-InducedAdultCongenital AbnormalitiesEuropeFemaleHumansInfant, NewbornInsulinsLogistic ModelsMalePregnancyPregnancy ComplicationsPregnancy in DiabeticsPregnancy OutcomePregnancy Trimester, FirstPrenatal Exposure Delayed EffectsInsulinsdiabetes in pregnancyepidemiologymaternal medicine

Identifiers

PMID29478010
PMCPMC5855464
OpenAlexW2794185942

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.