Study of Nicotine Replacement Therapy in Pregnancy

• Status: Withdrawn
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Nicotine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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