Status:
WITHDRAWN
Study of Nicotine Replacement Therapy in Pregnancy
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Smoking Cessation
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
The overall objective of this study is to assess the effectiveness of NRT (Nicoderm patches) plus counselling treatment in women in the second and third trimester of pregnancy.
Detailed Description
Smoking during pregnancy is a major public health issue, causing miscarriages, prematurity, intrauterine growth retardation, stillbirth, and the Sudden Infant Death Syndrome (SIDS). It is estimated th...
Eligibility Criteria
Inclusion
- Women who smoke
- Pregnant women after 12 weeks gestation, confirmed by ultrasound
- On the day of the recruitment, women will be at least 18 years old and no older than 40 years old
- Agree to sign consent form and participate in all aspects of the follow-up
Exclusion
- Women who refuse to participate in the study/sign a written consent
- Women with insufficient English language skills to understand the questionnaires and assessment material
- Women with multiple pregnancy
- Women with confirmed cardiac pathology
- Women who receive concurrent treatment with Bupropion
- Congenital malformations visualized by ultrasound
- Objection from the physician caring for the woman to her participation
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00744913
Start Date
August 1 2008
End Date
March 1 2010
Last Update
August 15 2013
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