N/A
N=885,185
Varenicline Pregnancy Cohort Study
Malformations
Bottom Line
View on ClinicalTrials.gov: NCT01290445 ↗Enrolled (actual)
885,185
Serious AEs
—
Results posted
Jan 2019
Primary outcome: Primary: Number of Infants With Major Congenital Malformations — 12; 3382; 33950 infants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- varenicline (Drug); cigarette smoke from maternal smoking (Behavioral); Non-Exposure (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Infants With Major Congenital Malformations |
12; 3382; 33950 | — |
| SECONDARY Number of Infants With Stillbirths |
1; 384; 2418 | — |
| SECONDARY Number of Infants Born Small for Gestational Age (SGA) |
42; 13433; 73135 | — |
| SECONDARY Number of Infants Born Preterm |
25; 6173; 46732 | — |
| SECONDARY Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes |
12; 4246; 30641 | — |
| SECONDARY Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS) |
0; 51; 58 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01290445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.