Trial Outcomes & Findings for Varenicline Pregnancy Cohort Study (NCT NCT01290445)
NCT ID: NCT01290445
Last Updated: 2023-07-24
Results Overview
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.
COMPLETED
885185 participants
For 12 months after birth
2023-07-24
Participant Flow
Participant milestones
| Measure |
Varenicline Exposed Cohort
Participants included infants who were exposed to varenicline in utero.
|
Varenicline Unexposed Cohort
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
|
Reference Cohort
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
|
|---|---|---|---|
|
Overall Study
STARTED
|
335
|
78412
|
806438
|
|
Overall Study
COMPLETED
|
335
|
78412
|
806438
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Varenicline Pregnancy Cohort Study
Baseline characteristics by cohort
| Measure |
Varenicline Exposed Cohort
n=335 Participants
Participants included infants who were exposed to varenicline in utero.
|
Varenicline Unexposed Cohort
n=78412 Participants
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
|
Reference Cohort
n=806438 Participants
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
|
Total
n=885185 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Less Than (<) 32 weeks
|
3 infants
n=5 Participants
|
1036 infants
n=7 Participants
|
6275 infants
n=5 Participants
|
7314 infants
n=4 Participants
|
|
Age, Customized
32-36 weeks
|
22 infants
n=5 Participants
|
5137 infants
n=7 Participants
|
40457 infants
n=5 Participants
|
45616 infants
n=4 Participants
|
|
Age, Customized
Greater Than or Equal to (>=) 37 weeks
|
310 infants
n=5 Participants
|
72239 infants
n=7 Participants
|
759706 infants
n=5 Participants
|
832255 infants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
156 infants
n=5 Participants
|
38044 infants
n=7 Participants
|
392755 infants
n=5 Participants
|
430955 infants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
179 infants
n=5 Participants
|
40328 infants
n=7 Participants
|
413485 infants
n=5 Participants
|
453992 infants
n=4 Participants
|
|
Sex/Gender, Customized
Unknown
|
0 infants
n=5 Participants
|
40 infants
n=7 Participants
|
198 infants
n=5 Participants
|
238 infants
n=4 Participants
|
PRIMARY outcome
Timeframe: For 12 months after birthPopulation: Analysis population included all live born infants in Denmark and Sweden from May 1, 2007 through December 31, 2012.
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.
Outcome measures
| Measure |
Varenicline Exposed Cohort
n=334 Participants
Participants included infants who were exposed to varenicline in utero.
|
Varenicline Unexposed Cohort
n=78028 Participants
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
|
Reference Cohort
n=804020 Participants
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
|
|---|---|---|---|
|
Number of Infants With Major Congenital Malformations
|
12 infants
|
3382 infants
|
33950 infants
|
SECONDARY outcome
Timeframe: At the time of birthPopulation: Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.
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.
Outcome measures
| Measure |
Varenicline Exposed Cohort
n=335 Participants
Participants included infants who were exposed to varenicline in utero.
|
Varenicline Unexposed Cohort
n=78412 Participants
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
|
Reference Cohort
n=806438 Participants
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
|
|---|---|---|---|
|
Number of Infants With Stillbirths
|
1 infants
|
384 infants
|
2418 infants
|
SECONDARY outcome
Timeframe: At the time of birthPopulation: Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.
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.
Outcome measures
| Measure |
Varenicline Exposed Cohort
n=335 Participants
Participants included infants who were exposed to varenicline in utero.
|
Varenicline Unexposed Cohort
n=78412 Participants
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
|
Reference Cohort
n=806438 Participants
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
|
|---|---|---|---|
|
Number of Infants Born Small for Gestational Age (SGA)
|
42 infants
|
13433 infants
|
73135 infants
|
SECONDARY outcome
Timeframe: At the time of birthPopulation: Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.
Preterm birth was defined as birth before the gestational age of 37 weeks.
Outcome measures
| Measure |
Varenicline Exposed Cohort
n=335 Participants
Participants included infants who were exposed to varenicline in utero.
|
Varenicline Unexposed Cohort
n=78412 Participants
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
|
Reference Cohort
n=806438 Participants
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
|
|---|---|---|---|
|
Number of Infants Born Preterm
|
25 infants
|
6173 infants
|
46732 infants
|
SECONDARY outcome
Timeframe: At the time of birthPopulation: Analysis population included all infants born in Denmark and Sweden from May 1, 2007 through December 31, 2012.
Outcome measures
| Measure |
Varenicline Exposed Cohort
n=335 Participants
Participants included infants who were exposed to varenicline in utero.
|
Varenicline Unexposed Cohort
n=78412 Participants
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
|
Reference Cohort
n=806438 Participants
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
|
|---|---|---|---|
|
Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes
|
12 infants
|
4246 infants
|
30641 infants
|
SECONDARY outcome
Timeframe: For 12 months after birthPopulation: 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.
Sudden Infant Death Syndrome (SIDS) was defined as a sudden unexplained death of an infant less than one year of age.
Outcome measures
| Measure |
Varenicline Exposed Cohort
n=307 Participants
Participants included infants who were exposed to varenicline in utero.
|
Varenicline Unexposed Cohort
n=71720 Participants
Participants included infants who were exposed to maternal smoking, but not to varenicline in utero.
|
Reference Cohort
n=755939 Participants
Participants included infants who were neither exposed to maternal smoking nor to varenicline in utero.
|
|---|---|---|---|
|
Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS)
|
0 infants
|
51 infants
|
58 infants
|
Adverse Events
Varenicline Exposed Cohort
Varenicline Unexposed Cohort
Reference Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER