Study of Nicotine Patch in Pregnancy (SNIPP)
Condition: Smoking
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.

      At the inclusion visit when the women are smoking, saliva cotinine is collected and
      determined. The first dose of nicotine is adapted according to the saliva cotinine when
      smoking to obtain approximately 100 % substitution. A second saliva cotinine determination is
      realized 2 weeks later and at the next visit nicotine's daily dose is determined according to
      this second saliva cotinine results for the whole duration of pregnancy. This dose-adaptation
      is necessary to avoid as far as possible under- and overdosing of nicotine.

      The women undergo monthly visits as it is usual and recommended in France. They are followed
      as well as their newborn up to 2 months after birth.

      During the visits standard obstetrical information along with smoking related information and
      the routinely realized echography data are recorded and birth characteristics collected.

      In a subgroup of pregnant women having given their written informed consent and undergoing an
      amniocentesis for medical reasons, nicotine and cotinine in amniotic fluid will be
      determined.

      In a subgroup of pregnant women having given their written informed consent and breast
      feeding their baby during the 2 months period after birth, nicotine and cotinine in maternal
      milk are determined.

      There are 2 main outcome comparisons between the nicotine patch and the placebo patch groups:
      birth weight and maternal continuous, complete abstinence during pregnancy
    

Intervention name(s): nicotine versus placebo
Intervention type(s): Drug
Intervention description(s): 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.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Smoking; pregnancy; newborn; birth weight; nicotine patch; birth