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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
| Karolinska Institutet | OTHER |
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A prospective population-based cohort study to examine whether varenicline use during pregnancy is associated with an increased risk of major congenital malformations in infants above that associated with smoking during pregnancy.
Sampling will not be employed. The data sources record nearly all (>98.6%) births in Denmark and Sweden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed | Infants exposed in utero to varenicline |
| |
| Unexposed | infants exposed in utero to cigarette smoke from maternal smoking |
| |
| Reference | infants not exposed in utero to either varenicline or cigarette smoke from maternal smoking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varenicline | Drug | This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Infants With Major Congenital Malformations | Major congenital malformations were defined as any codes within the Q-chapter of The Tenth Revision of the International Classification of Diseases (ICD-10), excluding certain minor anomalies. | For 12 months after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Infants With Stillbirths | Stillbirth was defined as death at a gestational age of greater than or equal to (>=) 22 weeks, with the exception that in Sweden prior to 2008 it was defined as death at a gestational age of >=28 weeks. | At the time of birth |
| Number of Infants Born Small for Gestational Age (SGA) |
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Inclusion Criteria:
All live and stillbirths between May 2007 and December 2012 in Denmark and Sweden.
Exclusion Criteria:
Births less than 22 weeks of gestation in Denmark and 28 weeks in Sweden are not recorded by the registers.
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The study population will consist of all live born and stillborn infants in Denmark and Sweden.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Varenicline Exposed Cohort | Participants included infants who were exposed to varenicline in utero. |
| FG001 | Varenicline Unexposed Cohort | Participants included infants who were exposed to maternal smoking, but not to varenicline in utero. |
| FG002 | Reference Cohort | Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.
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| ID | Title | Description |
|---|---|---|
| BG000 | Varenicline Exposed Cohort | Participants included infants who were exposed to varenicline in utero. |
| BG001 | Varenicline Unexposed Cohort | Participants included infants who were exposed to maternal smoking, but not to varenicline in utero. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Reported age is the gestational age of infants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Infants With Major Congenital Malformations | Major congenital malformations were defined as any codes within the Q-chapter of The Tenth Revision of the International Classification of Diseases (ICD-10), excluding certain minor anomalies. | Analysis population included all live born infants in Denmark and Sweden from May 1, 2007 through December 31, 2012. | Posted | Number | infants | For 12 months after birth |
|
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Since this was a non interventional study using secondary data sources, collection and reporting of adverse events were not applicable.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Varenicline Exposed Cohort | Participants included infants who were exposed to varenicline in utero. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| ID | Term |
|---|---|
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| cigarette smoke from maternal smoking | Behavioral | This is a non-interventional study. Exposure in utero to cigarette smoke from maternal smoking is observed, not assigned. |
|
| Non-Exposure | Other | This is a non-interventional study. Non-exposure in utero to varenicline and cigarette smoke from maternal smoking is observed, not assigned. |
|
An infant was defined as SGA if birth weight was below the 10th percentile of its sex-specific national distribution at the respective gestational week. Data on birth weight and gestational age from the medical birth registries were used to calculate the 10th percentiles for each sex based on all Danish and Swedish births during the study observation period. |
| At the time of birth |
| Number of Infants Born Preterm | Preterm birth was defined as birth before the gestational age of 37 weeks. | At the time of birth |
| Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes | At the time of birth |
| Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS) | Sudden Infant Death Syndrome (SIDS) was defined as a sudden unexplained death of an infant less than one year of age. | For 12 months after birth |
| BG002 | Reference Cohort | Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero. |
| BG003 | Total | Total of all reporting groups |
| Number |
| infants |
|
| Sex/Gender, Customized | Number | infants |
|
| OG002 | Reference Cohort | Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero. |
|
|
|
| Secondary | Number of Infants With Stillbirths | Stillbirth was defined as death at a gestational age of greater than or equal to (>=) 22 weeks, with the exception that in Sweden prior to 2008 it was defined as death at a gestational age of >=28 weeks. | Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012. | Posted | Number | infants | At the time of birth |
|
|
|
|
| Secondary | Number of Infants Born Small for Gestational Age (SGA) | An infant was defined as SGA if birth weight was below the 10th percentile of its sex-specific national distribution at the respective gestational week. Data on birth weight and gestational age from the medical birth registries were used to calculate the 10th percentiles for each sex based on all Danish and Swedish births during the study observation period. | Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012. | Posted | Number | infants | At the time of birth |
|
|
|
|
| Secondary | Number of Infants Born Preterm | Preterm birth was defined as birth before the gestational age of 37 weeks. | Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012. | Posted | Number | infants | At the time of birth |
|
|
|
|
| Secondary | Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes | Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012. | Posted | Number | infants | At the time of birth |
|
|
|
|
| Secondary | Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS) | Sudden Infant Death Syndrome (SIDS) was defined as a sudden unexplained death of an infant less than one year of age. | Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012. Here, 'Number of participants analyzed' signifies participants who were evaluable for this outcome measure. | Posted | Number | infants | For 12 months after birth |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Varenicline Unexposed Cohort | Participants included infants who were exposed to maternal smoking, but not to varenicline in utero. | 0 | 0 | 0 | 0 |
| EG002 | Reference Cohort | Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero. | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D011810 | Quinoxalines |
| Odds Ratio (OR) |
| 0.65 |
| 2-Sided |
| 95 |
| 0.09 |
| 4.67 |
| Superiority or Other (legacy) |
| Odds Ratio (OR) |
| 0.70 |
| 2-Sided |
| 95 |
| 0.51 |
| 0.97 |
| Superiority or Other (legacy) |
| Odds Ratio (OR) |
| 0.91 |
| 2-Sided |
| 95 |
| 0.61 |
| 1.37 |
| Superiority or Other (legacy) |
| Odds Ratio (OR) |
| 0.65 |
| 2-Sided |
| 95 |
| 0.37 |
| 1.16 |
| Superiority or Other (legacy) |