Clinical trial NCT00744913: Study of Nicotine Replacement Therapy in Pregnancy
Official title: Randomized, Controlled Open-Label Study of Nicotine Replacement Therapy in Pregnancy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: Pregnancy
Women
Nicotine replacement therapy
Smoking cessation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2008-09-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: To assess the effectiveness of NRT (Nicoderm patches) at doses of 14 mg/day or 21 mg/day plus counselling treatment
timeFrame: 6 months
Secondary outcomes:
measure: To compare the effectiveness of counseling and NRT at doses of 14 mg/day or 21 mg/day with counselling alone.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: The Hospital for Sick Children
name: Gideon Koren, MD
role: PRINCIPAL_INVESTIGATOR
References: