Study of Nicotine Replacement Therapy in Pregnancy

Smoking Cessation Clinical Trial

Official title:

Randomized, Controlled Open-Label Study of Nicotine Replacement Therapy in Pregnancy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00744913
• Other study ID #: 1000010740
• Status: Withdrawn
• Phase: Phase 3
• First received: August 29, 2008
• Last updated: August 14, 2013
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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 that 25-40% of pregnant smokers try to stop smoking on their own upon learning that they are pregnant. While pregnancy is often a strong motivator for smoking cessation, many nicotine-dependent women cannot quit smoking. The most important factor underlying the inability to quit smoking is strong dependence on a certain level nicotine, which is unique in every individual.

Several publications have shown that the use of the nicotine patch during the second and third trimesters is not associated with maternal or fetal compromise. More importantly, nicotine replacement therapy (NRT) during pregnancy exposes the fetus to lower levels of nicotine than smoking cigarettes does and, moreover, eliminates exposure to numerous other toxic substances.

Presently, counselling is the standard mode of treatment for the pregnant patients willing to quit smoking. Since pharmacologic smoking cessation therapies have been shown to increase significantly up to doubling a successful quitting rate when used in adjunction to brief physician counselling, the use of an appropriate dose of such agents is essential.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Nicoderm patches
Women in this group will receive standard counselling and NRT (Nicoderm patches) starting with a dose of 14 mg/day that can be increased to 21 mg/day based on response (smoking cessation) and potential side effects

Other:
• Counselling
Women in this arm of the study will receive standard counseling only.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effectiveness of NRT (Nicoderm patches) at doses of 14 mg/day or 21 mg/day plus counselling treatment		6 months	No
Secondary	To compare the effectiveness of counseling and NRT at doses of 14 mg/day or 21 mg/day with counselling alone.		6 months	No