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September 25, 2014BMC Pregnancy and ChildbirthOpen Access

Increased risk of severe congenital heart defects in offspring exposed to selective serotonin-reuptake inhibitors in early pregnancy – an epidemiological study using validated EUROCAT data

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Why the study?

Does maternal use of selective serotonin-reuptake inhibitors during early pregnancy increase the risk of severe congenital heart defects in offspring?

Population

72,280 registered pregnancies in Funen, Denmark in the period 1995-2008

Comparison

Selective serotonin-reuptake inhibitors used… vs No SSRI use during first trimester

Design

Cohort

Key result

Maternal use of selective serotonin-reuptake inhibitors during the first trimester increased the risk of severe congenital heart defects in offspring by four times (AOR 4.03).

Authors

TKTanja Majbrit KnudsenAHAnne Vinkel HansenEGEster Garne

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Overview

May warrant caution with first-trimester SSRI use; leaves open causal confirmation in larger studies.

Study Design

Type

Cohort (n=72,280)

Structured PICO

Does maternal use of selective serotonin-reuptake inhibitors during early pregnancy increase the risk of severe congenital heart defects in offspring?

P
Population
72,280 registered pregnancies in Funen, Denmark in the period 1995-2008
I
Intervention
Selective serotonin-reuptake inhibitors (SSRIs) used during first trimester
C
Comparator
No SSRI use during first trimester
O
Outcome
Severe congenital heart defects (CHD) in offspringhard clinical

Main Result

Effect estimate: AOR 4.03 (95% CI 1.75-9.26)

Absolute Event Rate: 0.71% vs 0.17%

Maternal use of SSRIs during the first trimester is associated with a four-fold increased risk of severe congenital heart defects in offspring, though not septal defects.

Limitations

  • Limited size of the study population resulting in lack of statistical power for specific diagnoses and interactions.
  • Risk of misclassification of exposure since prescription redemption does not guarantee medication consumption.
  • Lack of information on important potential confounders due to reliance on administrative registers.
  • Grouping of CHD diagnoses with heterogeneous etiology may dilute the studied association.

Cite This Study

Knudsen et al. (2014) conducted a cohort in Pregnancy (n=72,280). Selective serotonin-reuptake inhibitors (SSRIs) vs. Unexposed (no SSRI prescription during the exposure window) was evaluated on Severe congenital heart defects (AOR 4.03, 95% CI 1.75-9.26). Maternal use of selective serotonin-reuptake inhibitors during the first trimester increased the risk of severe congenital heart defects in offspring by four times (AOR 4.03).

synapsesocial.com/papers/6a10beed8102eb4b66ee4ce7https://doi.org/10.1186/1471-2393-14-333
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