Bupropion & Cardio Birth Defect (Slone)

Bupropion is a unique drug that is used both to treat depression and as an aid in smoking cessation. In 2008, the final report from the Bupropion pregnancy registry described 24 congenital malformations among the 675 women exposed to bupropion in the first trimester of pregnancy. Of these, 9 had congenital heart disease of varying severity, including a number of infants with ventricular septal defects (VSDs); of note, 2 of these 9 had coarctation of the aorta. More recently, Alwan et al, in an analysis of data from the Centers for Disease Control and Prevention's case-control National Birth Defects Prevention Study, reported an increased risk of left outflow tract heart defects, a subgroup of cardiac malformations that includes coarctation of the aorta and hypoplastic left heart syndrome.

Data from the Slone Epidemiology Center Birth Defects Study will be used to test these observations. The outcomes of primary interest will include those hypothesized to be associated with bupropion in recent studies: left outflow tract defects considered as a group. Coarctation of the aorta and hypoplastic left heart syndrome will also be examined separately. All infants with congenital heart defects are further classified into subgroups that are embryologically meaningful, including left outflow tract defects. In secondary analyses, other heart defect classes for which there are adequate numbers of cases will be evaluated.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depressive Disorder Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Mental Disorders Mood Disorders

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with congenital heart defects who are born within the catchment areas of the 4 study centers
A sample of nonmalformed infants born at participating hospitals
Subjects who were interviewed in 1992 or later
Women who complete the study interview within 6 months of the infant's birth

Exclusion criteria

Infants with chromosomal anomalies

Treatment and study plan

Exposure to any bupropion during the first trimester

Drug

The primary exposure group will be: any exposure to bupropion during the time period from 28 days prior to the last menstrual period through the fourth lunar month. The use of bupropion in combination with other anti-depressants, exposure to SSRI anti-depressants, and exposure to non-SSRI anti-depressants, including tricyclic anti-depressants, during this time period will be explored.

Mothers of identified infants are contacted within 6 months of delivery and invited to participate in the study by completing a telephone interview, conducted by trained study nurses. The interview addresses demographic, reproductive, and medical factors; medication and vitamin use; cigarette smoking, alcohol, and caffeine consumption, occupational exposures, and dietary intake. Exposure information is obtained directly from the mother in response to questions that focus both on indications for medication use and on medications themselves.

Exposure to bupropion alone during the first trimester

Drug

The secondary exposure group will be: bupropion exposure alone during the time period from 28 days prior to the last menstrual period through the fourth lunar month.

Referent group: no exposure to any anti-depressant or anti-smoking drug during pregnancy

Other

The referent group will be defined as no exposure to any anti-depressant or anti-smoking drug at any time from 28 days prior to the last menstrual period through the end of pregnancy.

Primary outcomes

Diagnosis of left outflow tract defects

Time frame: Within 6 months of delivery
Diagnosis of coarctation of the aorta

Time frame: Within 6 months of delivery
Diagnosis of hypoplastic left heart syndrome

Time frame: Within 6 months of delivery

Secondary outcomes

Diagnosis of other congenital heart defects

Time frame: Within 6 months of delivery

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Bupropion and Cardiac Birth Defects (Slone Epidemiology Center)

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: May 14, 2012
Registry last updated: Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed