Bupropion & Cardio Birth Defect (Slone)

NCT ID: NCT01597661

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-08-31

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.

Conditions

Depressive Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Malformed and population-based sample of non-malformed infants

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.

Exposure to any bupropion during the first trimester

Intervention Type: 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

Intervention Type: 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.

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.

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

Intervention Type: 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.

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.

Interventions

Exposure to any bupropion during the first trimester

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.

Intervention Type: DRUG

Exposure to bupropion alone during the first trimester

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.

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.

Intervention Type: DRUG

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

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.

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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

WEUSKOP5344

Identifier Type: OTHER

Identifier Source: secondary_id

EPI40662

Identifier Type: OTHER

Identifier Source: secondary_id

115433

Identifier Type: -

Identifier Source: org_study_id