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Nicotine patches in pregnant smokers: randomised. SURPRISE!

Discussion in 'Tobacco Harm Reduction' started by VapeMeStoopid, Mar 13, 2014.

  1. Abstract

    Objective To determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day).

    Design Randomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013.

    Setting 23 maternity wards in France.

    Participants 476 pregnant smokers aged more than 18 years and between 12 and 20 weeks’ gestation, who smoked at least five cigarettes a day. After exclusions, 402 women were randomised: 203 to nicotine patches and 199 to placebo patches. Data were available on 192 live births in each group.

    Interventions Nicotine and identical placebo patches were administered from quit day up to the time of delivery. Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100%. Participants were assessed monthly and received behavioural smoking cessation support.

    Main outcome measures The primary outcomes were complete abstinence (self report confirmed by carbon monoxide level in expired air ≤8 ppm) from quit date to delivery, and birth weight. The secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics. All data were analysed on an intention to treat basis.

    Results Complete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self reported median compliance rate was 85% (interquartile range 56-99%) in the nicotine patch group and 83% (56-95%) in the placebo patch group, assessed at 1016 visits. The mean 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). Diastolic blood pressure was significantly higher in the nicotine patch group than in the placebo patch group. The frequency of serious adverse events was similar between the groups, although more non-serious adverse reactions, mainly of skin, occurred in the nicotine patch group.

    Conclusion The nicotine patch did not increase either smoking cessation rates or birth weights despite adjustment of nicotine dose to match levels attained when smoking, and higher than usual doses.

    Trial registration ClinicalTrials.gov NCT00507975.
  2. Purplefowler

    Purplefowler Administrator Staff Member

    Jul 11, 2012
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    I was lucky. The first sign that I was pregnant (other than throwing up) was that I couldn't stand the smell of ciggies, it made me gag. It made life lots easier! I also couldn't handle the smell of oil or machinery which was a little unfortunate as my OH is a smoking engineer! He'd come through the front door and I'd have to leg it to the bathroom :)
  3. I couldnt handle the smell of cooking meat...cooked meat was fine, raw meat was fine...any meat cooking I was praying to the porcelain!
    • Like Like x 1
  4. Chegs

    Chegs Veteran

    Sep 15, 2013
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  5. gords1001

    gords1001 Achiever

    Oct 12, 2013
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    Quite a sexist test though, where were the male subjects? I feel a complaint to the court of human rights coming on, its totally sexist to assume that just because I'm a man, I cant be pregnant......

    *sarcasm mode off*

    Its pretty shocking that out of the 400 tested, only 10% managed to quit using medically approved quitting aids. Kind of shows where vaping will go if the pharmaceutical industry gets their hands on it, they cant even get a device they've had 30 years to develop to work, what are their coils and wicks going to look like?
  6. steffijade

    steffijade Achiever

    Jul 11, 2012
    Likes Received:
    If they find the 'magic bullet' that can make everyone quit, they'd lose their target market and their tobacco control buddies would all be out of a job.

    Which is why they're happy enough to just keep making profit from inferior products whilst their tobacco control buddies get to make a living demonising smokers and acting morally superior.

    Money for old rope... until you introduce vaping into the equation.
    • Like Like x 1
  7. EthelKing

    EthelKing Veteran

    Jul 18, 2012
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    I'm confused. How did the nicotine patches get inside the randomised pregnant women? :D
    • Like Like x 1
  8. Ninjaassasin1983

    Ninjaassasin1983 Veteran

    Oct 24, 2013
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    as a man i wouldnt ever want to be pregnant i'm sure all the ladies would love to see you try to squeeze a babby out from the end of your peepee though
  9. anthonyb

    anthonyb Achiever

    Jun 23, 2013
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    This bit gets me, (unless I've mis-read something) "carbon monoxide level in expired air ≤8 ppm".
    As I was on that research study, (that was posted somewhere here),yesterday day. And remember, I was a smoker for 35+ yrs. My reading on both goes at the carbon monoxide detector came in at 2 ppm.
    So if we take a look at the scientific evidence, pregnant women using patches, are more of a health risk, with all of the carbon monoxide they are breathing out. Than me with an ecig.
    So those health bods, that say "think of the children" where ecigs are concerned. Actually do more harm to the children, with their own "SAFE" nicotine patches.

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