Randomized, Controlled Open-Label Study of Nicotine Replacement Therapy in Pregnancy
概览
- 阶段
- 3 期
- 干预措施
- Counselling
- 疾病 / 适应症
- Smoking Cessation
- 发起方
- The Hospital for Sick Children
- 主要终点
- To assess the effectiveness of NRT (Nicoderm patches) at doses of 14 mg/day or 21 mg/day plus counselling treatment
- 状态
- 撤回
- 最后更新
- 12年前
概览
简要总结
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.
详细描述
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.
研究者
Gideon Koren
Director of MotherRisk Program, Clinical Pharmacology and Toxicology
The Hospital for Sick Children
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
2
干预措施: Counselling
1
干预措施: Nicoderm patches
结局指标
主要结局
To assess the effectiveness of NRT (Nicoderm patches) at doses of 14 mg/day or 21 mg/day plus counselling treatment
时间窗: 6 months
次要结局
- To compare the effectiveness of counseling and NRT at doses of 14 mg/day or 21 mg/day with counselling alone.(6 months)