Clinical trial NCT01597661: Bupropion & Cardio Birth Defect (Slone)
Official title: Bupropion and Cardiac Birth Defects (Slone Epidemiology Center)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder
Keywords: first trimester
left outflow tract obstruction
Bupropion
cardiovascular malformation
antidepressants
pregnancy
cardiovascular defect
congenital malformation
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-05-14
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The primary focus of the Slone Epidemiology Center Birth Defects Study (BDS) case-control surveillance is to identify the risks and safety of marketed drugs taken by pregnant women. 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. Information gathered on each subject includes name, address, telephone number, diagnostic information, and date of birth. Beginning in 1992, the BDS also included mothers of non-malformed infants: initially these infants were identified exclusively at study hospitals, but in 1998, they expanded their normal newborn capability by obtaining a population-based random sample of newborns in Massachusetts.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis of left outflow tract defects
timeFrame: Within 6 months of delivery
measure: Diagnosis of coarctation of the aorta
timeFrame: Within 6 months of delivery
measure: Diagnosis of hypoplastic left heart syndrome
timeFrame: Within 6 months of delivery
Secondary outcomes:
measure: Diagnosis of other congenital heart defects
timeFrame: Within 6 months of delivery
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: