Study of Nicotine Replacement Therapy in Pregnancy
|ClinicalTrials.gov Identifier: NCT00744913|
Recruitment Status : Withdrawn (Discontinued due to difficulty in recruitment)
First Posted : September 1, 2008
Last Update Posted : August 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Drug: Nicoderm patches Other: Counselling||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized, Controlled Open-Label Study of Nicotine Replacement Therapy in Pregnancy|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||February 2010|
|Estimated Study Completion Date :||March 2010|
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
|Active Comparator: 2||
Women in this arm of the study will receive standard counseling only.
- To assess the effectiveness of NRT (Nicoderm patches) at doses of 14 mg/day or 21 mg/day plus counselling treatment [ Time Frame: 6 months ]
- To compare the effectiveness of counseling and NRT at doses of 14 mg/day or 21 mg/day with counselling alone. [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744913
|Principal Investigator:||Gideon Koren, MD||The Hospital for Sick Children|