Bupropion & Cardio Birth Defect (Slone)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Depressive Disorder

Treatments: Other: Referent group: no exposure to any anti-depressant or anti-smoking drug during pregnancy; Drug: Exposure to bupropion alone during the first trimester; Drug: Exposure to any bupropion during the first trimester

Study type: Observational

Funder types: Industry

Identifiers

NCT01597661

WEUSKOP5344 (Other Identifier)

115433

EPI40662 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1 participants in 1 patient group

Malformed and population-based sample of non-malformed infants

Description:

Infants with any of a wide range of malformations are identified at tertiary care and birth hospitals in four study centers (Boston, Philadelphia, Toronto, San Diego) using approaches that include reviewing lists of discharge diagnoses available in medical records; contacting newborn nursery and/or labor and delivery rooms; reviewing admission/discharge lists; and reviewing clinic and surgical logs. A population-based random sample of non-malformed newborns in Massachusetts is also included. Information gathered on each subject includes name, address, telephone number, diagnostic information, and date of birth.

Treatment:

Drug: Exposure to any bupropion during the first trimester

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

Drug: Exposure to bupropion alone during the first trimester