Emilia-Romagna Study on Pregnancy and Exposure to Antiepileptic drugs (ESPEA): A population-based study on prescription patterns, pregnancy outcomes and fetal health

Barbara Mostacci, Francesca Bisulli, Elisabetta Poluzzi, Guido Cocchi, Carlo Piccinni, Alessandra Curti, Giuliana Simonazzi, Gianni Astolfi, Nicola Rizzo, Corrado Zenesini, Roberto D'Alessandro, Paolo Tinuper

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objectives To assess the prevalence of antiepileptic drug (AED) exposure in pregnant women and the comparative risk of terminations of pregnancy (TOPs), spontaneous abortions, stillbirths, major birth defects (MBDs), neonatal distress and small for gestational age (SGA) infants following intrauterine AED exposure in the Emilia Romagna region, Italy (4 459 246 inhabitants on 31 December 2011). Methods We identified all deliveries and hospitalised abortions in Emilia Romagna in the period 2009-2011 from the certificate of delivery assistance registry (Certificato di Assistenza al Parto -CedAP) and the hospital discharge card registry, exposure to AEDs from the reimbursed drug prescription registries, MBDs from the regional registry of congenital malformations, and Apgar scores and cases of SGA from the CedAP. Records from different registries were linked. Results We identified 145 243 pregnancies: 111 284 deliveries, 16 408 spontaneous abortions and 17 551 TOPs. Six hundred and eleven pregnancies (0.42%; 95% Cl 0.39 to 0.46) were exposed to AEDs. In the AED-exposed group 21% of pregnancies ended in TOPs vs 12% in the non-exposed women (OR: 2.24; 95% CI 1.41 to 3.56). Rates of spontaneous abortions, stillbirths, neonatal distress and SGA were comparable. Three hundred and fifty-three babies (0.31%; 95% CI 0.28 to 0.35) were exposed to AEDs during the first trimester. MBD rates were 2.3% in the exposed vs 2.0% in the non-exposed pregnancies (OR: 1.12, 95% CI 0.55 to 2.55). Conclusion The Emilia Romagna prevalence of AED exposure in pregnancy was 0.42%, comparable with previous European studies. Rates of spontaneous abortions, stillbirths, neonatal distress, SGA and MBDs following AED exposure were not significantly increased. The rate of TOPs was significantly higher in the AED-exposed women.

Original languageEnglish
Pages (from-to)983-988
Number of pages6
JournalJournal of Neurology, Neurosurgery and Psychiatry
Volume89
Issue number9
DOIs
Publication statusPublished - Sep 1 2018

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Pregnancy Outcome
Anticonvulsants
Prescriptions
Pregnancy
Health
Registries
Spontaneous Abortion
Population
Stillbirth
Gestational Age
Small for Gestational Age Infant
Drug Prescriptions
Apgar Score
Birth Rate
Pregnancy Rate
First Pregnancy Trimester
Italy
Pregnant Women

Keywords

  • clinical neurology
  • epilepsy,anticonvulsants
  • neuropharmacology
  • pharmacology

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology
  • Psychiatry and Mental health

Cite this

Emilia-Romagna Study on Pregnancy and Exposure to Antiepileptic drugs (ESPEA) : A population-based study on prescription patterns, pregnancy outcomes and fetal health. / Mostacci, Barbara; Bisulli, Francesca; Poluzzi, Elisabetta; Cocchi, Guido; Piccinni, Carlo; Curti, Alessandra; Simonazzi, Giuliana; Astolfi, Gianni; Rizzo, Nicola; Zenesini, Corrado; D'Alessandro, Roberto; Tinuper, Paolo.

In: Journal of Neurology, Neurosurgery and Psychiatry, Vol. 89, No. 9, 01.09.2018, p. 983-988.

Research output: Contribution to journalArticle

Mostacci, Barbara ; Bisulli, Francesca ; Poluzzi, Elisabetta ; Cocchi, Guido ; Piccinni, Carlo ; Curti, Alessandra ; Simonazzi, Giuliana ; Astolfi, Gianni ; Rizzo, Nicola ; Zenesini, Corrado ; D'Alessandro, Roberto ; Tinuper, Paolo. / Emilia-Romagna Study on Pregnancy and Exposure to Antiepileptic drugs (ESPEA) : A population-based study on prescription patterns, pregnancy outcomes and fetal health. In: Journal of Neurology, Neurosurgery and Psychiatry. 2018 ; Vol. 89, No. 9. pp. 983-988.
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abstract = "Objectives To assess the prevalence of antiepileptic drug (AED) exposure in pregnant women and the comparative risk of terminations of pregnancy (TOPs), spontaneous abortions, stillbirths, major birth defects (MBDs), neonatal distress and small for gestational age (SGA) infants following intrauterine AED exposure in the Emilia Romagna region, Italy (4 459 246 inhabitants on 31 December 2011). Methods We identified all deliveries and hospitalised abortions in Emilia Romagna in the period 2009-2011 from the certificate of delivery assistance registry (Certificato di Assistenza al Parto -CedAP) and the hospital discharge card registry, exposure to AEDs from the reimbursed drug prescription registries, MBDs from the regional registry of congenital malformations, and Apgar scores and cases of SGA from the CedAP. Records from different registries were linked. Results We identified 145 243 pregnancies: 111 284 deliveries, 16 408 spontaneous abortions and 17 551 TOPs. Six hundred and eleven pregnancies (0.42{\%}; 95{\%} Cl 0.39 to 0.46) were exposed to AEDs. In the AED-exposed group 21{\%} of pregnancies ended in TOPs vs 12{\%} in the non-exposed women (OR: 2.24; 95{\%} CI 1.41 to 3.56). Rates of spontaneous abortions, stillbirths, neonatal distress and SGA were comparable. Three hundred and fifty-three babies (0.31{\%}; 95{\%} CI 0.28 to 0.35) were exposed to AEDs during the first trimester. MBD rates were 2.3{\%} in the exposed vs 2.0{\%} in the non-exposed pregnancies (OR: 1.12, 95{\%} CI 0.55 to 2.55). Conclusion The Emilia Romagna prevalence of AED exposure in pregnancy was 0.42{\%}, comparable with previous European studies. Rates of spontaneous abortions, stillbirths, neonatal distress, SGA and MBDs following AED exposure were not significantly increased. The rate of TOPs was significantly higher in the AED-exposed women.",
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T1 - Emilia-Romagna Study on Pregnancy and Exposure to Antiepileptic drugs (ESPEA)

T2 - A population-based study on prescription patterns, pregnancy outcomes and fetal health

AU - Mostacci, Barbara

AU - Bisulli, Francesca

AU - Poluzzi, Elisabetta

AU - Cocchi, Guido

AU - Piccinni, Carlo

AU - Curti, Alessandra

AU - Simonazzi, Giuliana

AU - Astolfi, Gianni

AU - Rizzo, Nicola

AU - Zenesini, Corrado

AU - D'Alessandro, Roberto

AU - Tinuper, Paolo

N1 - Ricercatore distaccato presso IRCCS a seguito Convenzione esclusiva con Università di Bologna (Bisulli Francesca, Tinuper Paolo)

PY - 2018/9/1

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N2 - Objectives To assess the prevalence of antiepileptic drug (AED) exposure in pregnant women and the comparative risk of terminations of pregnancy (TOPs), spontaneous abortions, stillbirths, major birth defects (MBDs), neonatal distress and small for gestational age (SGA) infants following intrauterine AED exposure in the Emilia Romagna region, Italy (4 459 246 inhabitants on 31 December 2011). Methods We identified all deliveries and hospitalised abortions in Emilia Romagna in the period 2009-2011 from the certificate of delivery assistance registry (Certificato di Assistenza al Parto -CedAP) and the hospital discharge card registry, exposure to AEDs from the reimbursed drug prescription registries, MBDs from the regional registry of congenital malformations, and Apgar scores and cases of SGA from the CedAP. Records from different registries were linked. Results We identified 145 243 pregnancies: 111 284 deliveries, 16 408 spontaneous abortions and 17 551 TOPs. Six hundred and eleven pregnancies (0.42%; 95% Cl 0.39 to 0.46) were exposed to AEDs. In the AED-exposed group 21% of pregnancies ended in TOPs vs 12% in the non-exposed women (OR: 2.24; 95% CI 1.41 to 3.56). Rates of spontaneous abortions, stillbirths, neonatal distress and SGA were comparable. Three hundred and fifty-three babies (0.31%; 95% CI 0.28 to 0.35) were exposed to AEDs during the first trimester. MBD rates were 2.3% in the exposed vs 2.0% in the non-exposed pregnancies (OR: 1.12, 95% CI 0.55 to 2.55). Conclusion The Emilia Romagna prevalence of AED exposure in pregnancy was 0.42%, comparable with previous European studies. Rates of spontaneous abortions, stillbirths, neonatal distress, SGA and MBDs following AED exposure were not significantly increased. The rate of TOPs was significantly higher in the AED-exposed women.

AB - Objectives To assess the prevalence of antiepileptic drug (AED) exposure in pregnant women and the comparative risk of terminations of pregnancy (TOPs), spontaneous abortions, stillbirths, major birth defects (MBDs), neonatal distress and small for gestational age (SGA) infants following intrauterine AED exposure in the Emilia Romagna region, Italy (4 459 246 inhabitants on 31 December 2011). Methods We identified all deliveries and hospitalised abortions in Emilia Romagna in the period 2009-2011 from the certificate of delivery assistance registry (Certificato di Assistenza al Parto -CedAP) and the hospital discharge card registry, exposure to AEDs from the reimbursed drug prescription registries, MBDs from the regional registry of congenital malformations, and Apgar scores and cases of SGA from the CedAP. Records from different registries were linked. Results We identified 145 243 pregnancies: 111 284 deliveries, 16 408 spontaneous abortions and 17 551 TOPs. Six hundred and eleven pregnancies (0.42%; 95% Cl 0.39 to 0.46) were exposed to AEDs. In the AED-exposed group 21% of pregnancies ended in TOPs vs 12% in the non-exposed women (OR: 2.24; 95% CI 1.41 to 3.56). Rates of spontaneous abortions, stillbirths, neonatal distress and SGA were comparable. Three hundred and fifty-three babies (0.31%; 95% CI 0.28 to 0.35) were exposed to AEDs during the first trimester. MBD rates were 2.3% in the exposed vs 2.0% in the non-exposed pregnancies (OR: 1.12, 95% CI 0.55 to 2.55). Conclusion The Emilia Romagna prevalence of AED exposure in pregnancy was 0.42%, comparable with previous European studies. Rates of spontaneous abortions, stillbirths, neonatal distress, SGA and MBDs following AED exposure were not significantly increased. The rate of TOPs was significantly higher in the AED-exposed women.

KW - clinical neurology

KW - epilepsy,anticonvulsants

KW - neuropharmacology

KW - pharmacology

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