Varenicline Pregnancy Cohort Study

Malformations Clinical Trial

Official title:

Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290445
• Other study ID #: A3051078
• Status: Completed
• Start date: September 13, 2007
• Est. completion date: May 1, 2016

Study information

• Verified date: August 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Sampling will not be employed. The data sources record nearly all (>98.6%) births in Denmark and Sweden.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 885185
• Est. completion date: May 1, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Malformations

Intervention

Drug:
• varenicline
This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned.

Behavioral:
• cigarette smoke from maternal smoking
This is a non-interventional study. Exposure in utero to cigarette smoke from maternal smoking is observed, not assigned.

Other:
• Non-Exposure
This is a non-interventional study. Non-exposure in utero to varenicline and cigarette smoke from maternal smoking is observed, not assigned.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Pfizer	Karolinska Institutet, University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	For 12 months after birth
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.	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.	At the time of birth
Secondary	Number of Infants Born Preterm	Preterm birth was defined as birth before the gestational age of 37 weeks.	At the time of birth
Secondary	Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes		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.	For 12 months after birth

External Links

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