---
title: Varenicline Pregnancy Cohort Study
nct_id: NCT01290445
overall_status: COMPLETED
sponsor: Pfizer
study_type: OBSERVATIONAL
primary_condition: Malformations
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01290445.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01290445"
ct_last_update_post_date: 2023-07-24
last_seen_at: "2026-05-12T07:12:35.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Varenicline Pregnancy Cohort Study

**Official Title:** Varenicline Pregnancy Cohort Study Protocol Chantix(Registered)/Champix(Registered) (Varenicline Tartrate)

**NCT ID:** [NCT01290445](https://clinicaltrials.gov/study/NCT01290445)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 885185
- **Lead Sponsor:** Pfizer
- **Collaborators:** University of Aarhus, Karolinska Institutet
- **Conditions:** Malformations
- **Start Date:** 2007-09-13
- **Completion Date:** 2016-05-01
- **CT.gov Last Update:** 2023-07-24

## Brief 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.

## Detailed Description

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

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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

## Interventions

- **varenicline** (DRUG) — This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned.
- **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.

## Primary Outcomes

- **Number of Infants With Major Congenital Malformations** _(time frame: For 12 months after birth)_ — 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.

## Secondary Outcomes

- **Number of Infants With Stillbirths** _(time frame: At the time of birth)_
- **Number of Infants Born Small for Gestational Age (SGA)** _(time frame: At the time of birth)_
- **Number of Infants Born Preterm** _(time frame: At the time of birth)_
- **Number of Infants Born To Mothers Diagnosed With Premature Rupture of Membranes** _(time frame: At the time of birth)_
- **Number of Infants Diagnosed With Sudden Infant Death Syndrome (SIDS)** _(time frame: For 12 months after birth)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01290445.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01290445*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*