Assessment of the Effectiveness of Nicotine Replacement Therapies (Nicotine Patches Delivering Nicotine 16 h/24 h) in 400 Pregnant Smokers. Randomized, Placebo-controlled, Multicenter, National Study. The SNIPP.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 2
- 主要终点
- Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery.
研究概览
简要总结
There are no established evidences as to the effectiveness in smoking pregnant women of nicotine patches in increasing birth weight, smoking abstinence during pregnancy and concerning the safety their for the fetus/newborn. Moreover, recent studies have shown that the metabolism of nicotine is speeded up in pregnant women suggesting that dose adaptation may be necessary in this population. The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
详细描述
Smoking during pregnancy is one of the main causes of low birth weight and several disorders during pregnancy involving the mother, the fetus/newborn or both. Only one previous study assessed the efficacy of 16 hours nicotine patch proposed for 3 months in pregnant women for smoking cessation. This study seemed to be underpowered and the compliance was very poor. However, some benefit on birth weight was observed.
The aim of the present study is to demonstrate whether nicotine replacement therapy with 16 h nicotine patch every day increases or not birth weight and abstinence during pregnancy in smoking women. Secondarily, it is aimed to provide descriptive information about the safety of nicotine patches in pregnant women.
This is a double blind, randomized, placebo controlled study. With 200 pregnant women in each arm it will have sufficient power to conclude about differences in birth weight and maternal abstinence between nicotine and placebo.
Women are recruited by health care professionals and directed to the obstetrical departments having previously been agreed to participate in the study.
After a grace period of one month without pharmacological treatment, the pregnant women are randomized into the placebo (N=200) or the nicotine group (N=200). Treatment duration is from randomization till delivery meaning a maximum length of drug/placebo exposure of 6 month during pregnancy. No treatment is started earlier than 3 months' pregnancy. Women may optionally continue their treatment for at least up to 2 months after birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •smoking pregnant woman unable to quit smoking during the first 3 months of pregnancy
- •smoking ≥ 5 cigaret/day despite standard medical advice and cognitive-behavioral counselling
- •aged ≥ 18 years
- •health insured
- •motivated to stop smoking; motivation score ≥ 5 on a scale ranging from 0 to 10
- •amenorrhea of 9 to 20 weeks
- •having signed the written informed consent
排除标准
- •non-pregnant women
- •Pregnant woman:
- •who does not agree to use a nicotine or placebo patch
- •with presence of chronic psychiatric comorbidity treated continuously by antidepressant, neuroleptic or anxiolytic
- •with skin disorder contraindicating the use of a transdermal patch
- •with known hypersensitivity to transdermal patch or to one of its constituents
- •using other nicotine containing pharmaceutical products (gum, lozenge, inhaler, sublingual tablets)
- •using other forms of tobacco than cigaret (cigaret, pipe or any form of smokeless tobacco)
研究组 & 干预措施
A
The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
干预措施: nicotine versus placebo (Drug)
B
The main aim of this study is to assess the effectiveness of nicotine patch comparatively to a placebo patch in pregnant women on birth weight and maternal smoking abstinence. The main secondary objective is the assessment of safety of these treatments for the fetus/newborn and for the mother.
干预措施: nicotine versus placebo (Drug)
结局指标
主要结局
Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery.
时间窗: from the first administration of nicotine/placebo patch until delivery
次要结局
- All adverse events occurring during pregnancy(during pregnancy)
- Point prevalence (7-days) smoking abstinence(7-days smoking abstinence)
- Vital signs of the mother and her body weight(during pregnancy)
- Echography results of the foetus(during the pregnancy)
- Birth characteristics of the newborn (Apgar, head circumference, height)(at the delivery)
- Compliance with treatment(during the study)