Study of Nicotine Patch in Pregnancy (SNIPP)
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.
Timeline
- Start
- 2007-11
- Primary completion
- 2012-11
- Completion
- 2012-11
Outcome
Missed primary endpoint
paper The nicotine patch did not increase either smoking cessation rates or birth weights PMID 24627552 ↗
paper birth weight was 3065 g (SE 44 g) in the nicotine patch group and 3015 g (SE 44 g) in the placebo patch group (P=0.41). PMID 24627552 ↗
Publications
- Results Wisborg K, Henriksen TB, Jespersen LB, Secher NJ. Nicotine patches for pregnant smokers: a randomized controlled study. Obstet Gynecol. 2000 Dec;96(6):967-71. doi: 10.1016/s0029-7844(00)01071-1.
- Results Benowitz N, Dempsey D. Pharmacotherapy for smoking cessation during pregnancy. Nicotine Tob Res. 2004 Apr;6 Suppl 2:S189-202. doi: 10.1080/14622200410001669169. No abstract available.
- Berlin I, Singleton EG, Heishman SJ. Cross validation of the prognostic and diagnostic utility of tobacco craving in a general and a pregnant sample of treatment-seeking smokers. Drug Alcohol Depend. 2015 Sep 1;154:174-83. doi: 10.1016/j.drugalcdep.2015.06.034. Epub 2015 Jun 29.
- Berlin I, Grange G, Jacob N, Tanguy ML. Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy. BMJ. 2014 Mar 11;348:g1622. doi: 10.1136/bmj.g1622.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nicotine | Unknown | — | Other |
Indications
No indication recorded.