Smoking Cessation in Pregnant Women

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Smoking Cessation in Pregnant Women

• Cheryl Oncken, M.D., MPH
• University of Connecticut School of Medicine

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Risks of Smoking During Pregnancy(Surgeon
Generals Report 2004)

• Maternal smoking is responsible for a number of
  poor pregnancy outcomes
• spontaneous abortion (RR1.2-1.3 )
• preterm delivery (OR1.3)
• placenta previa (RR1.3-4.4)
• placental abruption (RR1.4-2.4)
• low birth weight (RR1.5-2.5)
• Perinatal mortality (RR1.2-1.3)
• SIDS (OR1.4-3.0)

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Effect of Prenatal and Postnatal Tobacco Exposure
on Children

• Prenatal tobacco exposure
• Attention deficit disorder (Romano et al., 2008)
• Deficits in attention and auditory processing
  (Fried et al., 1997 Fried et al 2003)
• Increased risk of becoming a smoker (Kendell et
  al., 1994 Buka et al., 2003)
• Childhood obesity (Wideroe et. al., 2003)
• Postnatal tobacco exposure
• Increased risk of otitis media, pneumonia, asthma
  (DiFranza et al., 2004)

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Public Health Implications of Smoking During
Pregnancy

• In US, maternal smoking is estimated to be
  responsible for
• 30 of small for gestational age babies,
• 10 of preterm babies, and
• 5 of infant deaths (Salihu et al, MCH Journal
  2003)

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Benefits of Cessation

• Early cessation is best
• Women quit quit smoking by 16 weeks gestation
  have normal birth weight infants (MaCarther et
  al, 1988)
• Women who quit smoking by 30-36 weeks have near
  normal birth weight infants (Ahlsten et al.,
  1993)
• Smoking Reduction may also be beneficial
• 50 reduction in cotinine has been shown to
  improve birth weight (Li et al., 1993)

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Objectives

• Discuss natural history of smoking behavior
  during pregnancy
• Discuss treatment strategies
• Psychosocial
• Pharmacotherapy
• Discuss areas of future research

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Natural History of Smoking During Pregnancy

• 25 spontaneously quit smoking after learning of
  pregnancy (Floyd et al., 1993 LeClere Wilson,
  1997 Severson et al., 1995)
• Another 12 quit later on however, the majority
  of pregnant smokers cut down, but do not quit
  (Fingerhut et al., 1991)
• Of women who quit during pregnancy, about 70
  relapse within 1 year following delivery
  (Fingerhut et al., 1991)

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Continued Smokers vs. Spontaneous Quitters
(DiClemente et al., 2000 Phares TM et al., 2004)

• Less educated, lower SES, white, unemployed women
  are less likely to quit
• Heavier smokers are less likely to quit smoking
• Partner smoking is an independent risk factor for
  continued smoking during pregnancy

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Mental Health and Smoking during Pregnancy

• Nicotine dependence during pregnancy
  significantly predicted any mental disorder (OR
  3.3), any mood disorder (OR 2.5), major
  depression (OR 2.07), dysthymia (OR 6.2), panic
  disorder (OR 3.1) ( Goodwin et al., 2007)
• Pregnant smokers report more daily stressors and
  higher depressive symptoms than nonsmokers
  (Paarlberg et al., 1999 Zhu 2002)
• Women with current depressive disorders (i.e.,
  dysthymia, sub-threshold depression) may be less
  likely to quit (Blalock et al., 2006)

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Behavioral Interventions

• Two meta-analyses have shown that behavioral
  interventions have a consistent, although modest,
  impact on quit rates (Fiore, et al., 2008,
  Cochrane reviews 2004)
• In the USPHS guidelines, augmented behavioral
  interventions were at least 3 minutes and usually
  included discussion of risks and benefits and
  self-help materials (http//www.surgeongeneral.gov
  /tobacco)

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Meta-analysis Effectiveness of Psychosocial
Interventions
Fiore et al., 2008
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Examples Psychosocial Interventions

• Physician advice regarding smoking-related risks
  (2-3 minutes) videotape with information on
  risks, barriers and tips for quitting midwife
  counseling 10 minutes self-help manual with
  follow-up letters
• Pregnancy-specific materials (Pregnant Womans
  Guide To Quit Smoking) and one 10 minute
  counseling session
• Counselor provided one 90 minute counseling
  session with bi-monthly telephone calls

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Self-help Interventions ( Ershoff et al., 1989
Hjalmarson AI et al., 1991)
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Clinical Practice Guidelines suggestions to
improve disclosure (Fiore et al., 2008)

• Multiple choice format
• I smoke regularly now, about the same as when I
  found out I was pregnant
• I smoke regularly now, but Ive cut down since I
  found out I was pregnant
• I smoke every once and awhile
• I quit when I found out I was pregnant
• I wasnt smoking when I found out I was pregnant
  and I am not smoking now

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Clinical practice suggestions to assist women in
stopping smoking (Fiore et al., 2008)

• Congratulate those who have quit
• Motivate quit attempts by providing educational
  messages
• Use problem-solving methods
• Arrange Follow-up assessments
• Assess for relapse in early postpartum period

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Recommended Counseling for pregnant smokers
(Melvin et al., 2000)

• Ask (multiple choice format--document smoking
  status)
• Advise (
• Provide clear, strong messages about risks and
  benefits
• Assess (willingness to quit)
• Assist (3 minutes)
• Pregnancy specific, self-help materials
• Suggest and encourage problem solving -review
  previous methods
• Arrange social support
• Provide social support
• Arrange Follow-up
• Reassess at every visit

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Cochrane review (Lumley et al., 2004)

• Randomized and quasi-randomized trials
• 64 trials (approximately 28,000 subjects)
• Significant reduction in smoking in the
  intervention versus control groups (RR).94 95 CI
  .93 to .95.
• Absolute difference was 6 in 100 women
  continuing to smoke

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Cochrane Review (Lumley, 2004)
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Rewards for smoking cessation

• Low income women were randomized to voucher
  condition (50/month contingent on abstinence or
  to a control condition) (Donatelle et al., 2000)
• 32 vs 9 abstinence at the end of pregnancy
• 21 vs 6 postpartum
• 87 Pregnant smokers randomized to a contingent vs
  non contingent condition (Heil et al., 2008)
• 41 vs 9 abstinence at the end of pregnancy
• 24 vs 3 postpartum

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Considerations in the Use of Pharmacotherapy

• Pregnancy quit rates in meta-analyses average
  13.3
• Pharmacotherapies double quit rates in
  non-pregnant smokers
• However, the benefit/risk ratio is unknown among
  pregnant smokers

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Pharmacotherapies in Non-pregnant Smokers
Fiore et al., 2008 (Table 6.26)
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Clinical Practice GuidelinesFiore et al.
Clinical Practice Guidelines, 2008

• Safety is not categorical Although the use of
  NRT exposes pregnant women to nicotine, smoking
  exposes them to nicotine plus numerous other
  chemical that are injurious to the woman and the
  fetus. These concerns must be considered in the
  context of inconclusive evidence that cessation
  medications boost abstinence rates in pregnant
  smokers.

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Expert opinions regarding Pharmacotherapy
(Dempsey and Benowitz, 2000)

• Research is needed to better determine the
  risk/benefit profile
• Intermittent vs. continuous delivery system
  may deliver a lower total dose
• Pregnancy registries (prospective) would be
  useful to better determine the risk/benefit
  profile

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Pharmacotherapy in Practice

• 30 of physicians reported that they would
  discuss and/or prescribe pharmacotherapy to
  highly dependent smokers (Oncken et al., 2003)
• In a recent survey, 30 of pregnant smokers
  discussed pharmacotherapy with their health care
  provider 10 utilized either nicotine
  replacement or bupropion (Rigotti et al., 2008)
• Older age, more education, living with a partner,
  having an ob who discussed medication, private
  insurance

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Study of Nicotine Gum for Short- Term Smoking
Cessation in Pregnant Women

• Between-subjects design
• Compared the effects of 5 days of 2-mg nicotine
  gum use versus a wait-list control group on
• Plasma nicotine and cotinine concentrations
• maternal and fetal hemodynamics
• Oncken CA, Hatsukami DK, Lupo VR, et al. Effects
  of short term nicotine gum use in pregnant
  smokers Clin Pharmacol ther 199659654-1.

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Short-Term Use of Nicotine Gum

• May be useful for smoking cessation
• Nicotine gum results in a significant reduction
  in overall tobacco and nicotine exposure compared
  to continued smoking
• Favorable effect versus smoking on hemodynamic
  parameters (e.g., maternal BP and pulse)

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Efficacy of Nicotine Patch

• A large randomized trial found no overall
  efficacy of nicotine vs placebo patch, but did
  show an increase in birth weight (Wisborg et al.,
  2000)
• A smaller randomized trial (n30) of women who
  smoked at least 15 cigs per day found that 4/17
  (23.5) women quit with the nicotine patch ,
  whereas 0/13 in placebo group quit smoking
  (p0.11) (Kapur et al., 2001)

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Nicotine Patch for Pregnant Smokers

• 250 pregnant smokers who smoked 10 cigarettes/day
  
• Random assignment to 15 mg patches for 8 weeks,
  then 10 mg patches for 3 weeks versus placebo
• Overall 26 quit smoking- no advantage for TDN
• Compliance low in both groups
• Birth weights 186 gram increase in intervention
  vs. control group
• Wisborg K, Henrikson TB, Jesperson LB, Secher N.
  Nicotine patches for Pregnant smokers. Obstet
  Gynecol 200096967-71.

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Quit rates
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NRT Effectiveness Studies

• NRT as part of a multi-modal intervention
  resulted in higher cessation rates (14) vs usual
  care (5.0) (Hegaard et al., 2003)
• A large randomized open label found that addition
  of OTC NRT to counseling improved cessation rates
  over usual care (Pollack et al., 2007)

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Nicotine Replacement and Behavioral Therapy

• Randomized open-label two-arm design
• 21 randomization with more in NRT group
• Arm 1, Cognitive Behavioral Treatment
• Arm 2, Cognitive Behavioral Treatment NRT
• Choice of patch, gum, or lozenge (72 patch, 32
  gum, 12 chose the lozenge, 6 CBT)

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Results Cessation Rates
Adjusted for number of completed counseling
sessions indicates pCA, Lipkus et al., AJPM 200733297-305
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Serious Adverse Events

• 44/171 women had at least one SAE 34/113 (30)
  NRT vs. 10/58 (17) CBT
• RD0.13, 95 CI 0.00-0.26, p0.07
• After controlling for hx preterm birth
• RD0.09, 95 CI 0.05-0.21, p0.26
• Data and Safety Monitoring Board suspended
  enrollment after interim AE report
• Based on a priori stopping rule
• Concluded AEs likely not related to NRT use

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Bupropion SR
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Bupropion SR in pregnancy

• Non-nicotine medication, category B in pregnancy
  (US)
• Two prospective studies of bupropion SR in the
  first trimester did not find an increase in
  congential malformations or other adverse
  outcomes (Chun-Fai-Cahn B et al., 2005 Cole et
  al., 2006)
• Efficacy for smoking cessation
• One small study does not support an effect of
  bupropion SR on cessation rates (Miller et al.,
  2003)
• Effectiveness for smoking cessation
• In a controlled observational study, of 10/22
  (45) pregnant smokers receiving bupropion quit
  smoking, as compared to 3/22 (14) of controls (P
  0.047) (Chan et al., 2005)
• May be useful for pregnant smokers with
  co-existent mood problems

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Bupropion SR for smoking cessation and reduction
in pregnancy

• Double-blind placebo controlled trial
• 8 week intervention of Bupropion SR versus
  placebo
• Examined point prevalence abstinence at 4 and 8
  weeks
• Miller H, Ranger-Moore J, Hington M. et al.
  Bupropion SR for smoking cessation and reduction
  in pregnancy Am J Obstet Gynecol 2003189 S133

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Bupropion SR for Smoking Cessation or Reduction
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Pharmacotherapy for Smoking Cessation During
Pregnancy

• Randomized placebo-controlled trials have not
  shown efficacy, but risk/benefit ratio seems
  favorable
• Open-label, but not randomized controlled trials
  have shown effectiveness for NRT but have raised
  questions regarding safety
• Limited studies on buproprion SR
• More research is needed to better define the
  benefit/risk ratio

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Summary

• Pregnant smokers should be treated with known
  effective interventions (Fiore et al., 2008)
• Person-to-person psychosocial interventions that
  exceed minimal advice to quit
• Given the absence of definitive data on
  pharmacotherapy, individual decisions should be
  made between health care provider and pregnant
  smoker

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Future Directions

• Need to better understand risk factors for
  treatment failure
• Development of novel behavioral interventions
• Better understand the mechanisms by which
  treatments work
• Better assessment of the risks/benefits of
  pharmacotherapy
• Interventions are needed for heavier smokers
• Treatment-matching studies
• Studies to reduce postpartum relapse