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Teratogenic Risk Perception and Confidence in Use of Medicines in Pairs of Pregnant Women and General Practitioners Based on Patient Information Leaflets

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The aim of this study was to examine teratogenic risk perceptions and confidence in the use of medicines in pairs of pregnant women and general practitioners (GPs) through assessments of medicines information texts from patient information leaflets (PILs).


A questionnaire was handed out to women attending regular ultrasound examination in week 17–19 of pregnancy. The women stated name and address of their GP and questionnaires were sent to the GPs’ clinic. The questionnaires contained texts regarding pregnancy from PILs for pivmecillinam, metoclopramide, paracetamol, escitalopram, Valeriana officinalis and dexchlorpheniramine. For each PIL, teratogenic risk (scale from 0: never teratogenic to 10: always teratogenic), confidence in use of medicines (yes or no) and clarity of the text (scale from 0: exceptionally clear to 3: exceptionally unclear) were assessed.


In total, 171 pregnant women and 74 GPs participated, of which 98 pairs were identified. Pregnant women had significantly higher perceptions of teratogenic risks and lower confidence in use of medicines compared to GPs. Differences in teratogenic risk perceptions and confidence in use were highest for escitalopram and lowest for dexchlorpheniramine, representing texts with different phrasing and length. Neither pregnant women nor GPs were confident in using Valeriana officinalis.


Perceptions of teratogenic risks and confidence in use of medicines during pregnancy differ within pairs of pregnant women and their GP when they assess PILs. Phrasing of medicines information texts can influence teratogenic risk perceptions and thereby prescribing of medicines and adherence.

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We express gratitude to the reception staff at the ultrasound laboratory, the Department of Gynecology and Obstetrics at Haukeland University Hospital, for invaluable help with recruiting pregnant women. We also thank the participating pregnant women and the general practitioners.

Authors’ individual contribution to the manuscript:

SFW, JS and AGG conceived and planned the work that led to the manuscript. All authors played an important role in the acquisition, analysis and interpretation of the data. GEE and SFW performed the statistical analyses. SFW wrote the paper and all three co-authors made substantial suggestions for revisions. All authors approved the final submitted version.

Conflicts of interest:

The authors have no conflicts of interest to declare.

Sources of funding:

The Norwegian regional medicines information and Pharmacovigilance Centres, and the University of Bergen. The work was performed independently of the funders.

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Correspondence to Sofia Frost Widnes.

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Widnes, S.F., Schjøtt, J., Eide, G.E. et al. Teratogenic Risk Perception and Confidence in Use of Medicines in Pairs of Pregnant Women and General Practitioners Based on Patient Information Leaflets. Drug Saf 36, 481–489 (2013).

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