dangers of smoking before, during and after pregnancy

Upload: ashar-hidayat

Post on 04-Apr-2018

223 views

Category:

Documents


0 download

TRANSCRIPT

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    1/69

    Smoke-Free Families National Program Office

    Smoke-Free PregnanciesCollaborating Organizations

    Centers for Disease Control & Prevention

    Robert Wood Johnson Foundations

    Smoke-Free Families ProgramAmerican College of Obstetricians & Gynecologists

    Agency for Health Care Policy and Research

    Health Resources and Services Administration

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    2/69

    Smoke-Free Families National Program Office

    Dangers of Smoking

    Before, During and

    After Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    3/69

    Smoke-Free Families National Program Office

    Whats in a Cigarette?

    Blended tobacco plus:

    Artificial milk chocolate Artificial tobacco flavor

    Licorice flavor

    Fructose syrup

    Molasses Sucrose

    Vanilla

    Casing

    Cedarwood oil Ethanol

    Invert sugar

    Isovaleric acid

    Glycerol Hexanoic acid

    Methanol

    Olibanum oil

    Patchouli oil Phenylacetic acid

    Propylene glycol

    Valerian root

    Vanillin Vetiver oil

    3-methylpentanoic acid

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    4/69

    Smoke-Free Families National Program Office

    Smoking before Pregnancy

    Decreased ovulation

    Impaired tubal transport

    Reduced sperm count and motility The greater the number of

    cigarettes smoked, the greater the

    effect on fertility

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    5/69Smoke-Free Families National Program Office

    Smoking during PregnancyAdverse Outcomes

    Preterm birth

    Growth retardation

    Low birthweight Sudden Infant Death Syndrome (SIDS)

    Childhood illness

    School problems

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    6/69

    Smoke-Free Families National Program Office

    Smoking during PregnancyPregnancy Outcomes

    Outcome EffectMean Gestational Age Little or None

    Preterm Birth RR = 1.4

    Growth Retardation RR = 2.4Mean Birth weight - 149 grams

    A small proportion of preterm births, but 36% ofall growth retardation is attributable to smoking.

    Kramer, 1987

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    7/69

    Smoke-Free Families National Program Office

    Smoking during Pregnancy

    RiskFactors

    In the developed world, cigarettesmoking is the most powerful known

    determinant of fetal growth retardation.The relationship between smoking andlow birthweight is one of the mostconsistent findings in the epidemiologicliterature.

    Stein & Susser

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    8/69

    Smoke-Free Families National Program Office

    Smoking during Pregnancy

    Reasons for Reduced Fetal Growth

    Lower maternal weight gain

    Vasoconstriction and decreaseduterine blood flow

    Carbon monoxide toxicity

    Increased cyanide production

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    9/69

    Smoke-Free Families National Program Office

    Smoking during Pregnancy

    Passive ExposureMaternal exposure to passive

    smoking in early pregnancy more

    than doubles the risk of delivering

    a small-for-gestational-age infant.

    Dejin-KarlssonAJPH, 1998

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    10/69

    Smoke-Free Families National Program Office

    Smoking during PregnancyGrowth Retardation in Developed

    Countries-- Risk Factors

    Kramer, WHO Bulletin, 1987

    Cigarettesmoking

    Low weight

    gain

    Low pre-

    pregnancyweight

    Other (36%)

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    11/69

    Smoke-Free Families National Program Office

    Smoking during PregnancyLow Birthweight

    0

    5

    10

    15

    20

    25

    3035

    LBW

    (%)

    0 1-5 6-10 11-15 16-20 21-30 31+

    Cigarettes per Day

    Simpson, Am J OBGYN, 1957

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    12/69

    Smoke-Free Families National Program Office

    Smoking during PregnancySIDS

    Maternal smoking during pregnancyhas been associated with a 2-4 fold

    increased risk of SIDS Maternal postpartum smoking and

    smoking by others in the household

    has also been associated with SIDS

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    13/69

    Smoke-Free Families National Program Office

    Smoking after Pregnancy

    Children of smokers are more likelyto experience:

    Sudden Infant Death Syndrome (SIDS)

    Respiratory infection includingbronchitis and pneumonia

    Otitis media

    Asthma

    Hospitalization

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    14/69

    Smoke-Free Families National Program Office

    Smoking during Pregnancy

    Long-Term Effects on Children

    Decreased IQ

    Lower scores on spelling andreading tests

    Poorer school performance

    Shorter attention span

    More likely to be hyperactive

    Decreased height

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    15/69

    Smoke-Free Families National Program Office

    Smoking during PregnancyLong-Term Effects on Children

    Children of mothers who quit

    smoking during pregnancy scored

    5 points higher on IQ tests and hadbetter motor skills compared to

    those whose mothers did not quit.

    Sexton, 1990

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    16/69

    Smoke-Free Families National Program Office

    Which Women

    Smoke?

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    17/69

    Smoke-Free Families National Program Office

    Risk Factors For Smoking

    Low Education

    Young Age

    White Race

    Medicaid Recipient

    Partner Who Smokes

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    18/69

    Smoke-Free Families National Program Office

    Smoking during Pregnancy

    By Education

    Less than High School 26%

    High School Graduate 18%Some College 11%

    College Graduate 3%

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    19/69

    Smoke-Free Families National Program Office

    Smoking in Grade SchoolUSA 1975-1996

    0

    10

    20

    30

    40

    50

    1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1996

    Year

    Percent

    12th Grade

    10th Grade

    8th grade

    1 or more cigs. last 30 days

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    20/69

    Smoke-Free Families National Program Office

    Smoking Among Pregnant WomenUnited States, 1965-1996

    0

    5

    10

    15

    20

    25

    1989 1990 1991 1992 1993 1994 1995 1996

    Year

    Preva

    lence(%)

    Final Natality Statistics, 1989-1996

    S ki d i P

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    21/69

    Smoke-Free Families National Program Office

    Smoking during PregnancyBy Race and Ethnicity

    United States, 1996

    0

    5

    10

    15

    20

    25

    Prevale

    nce(%)

    AmericanIndian Alaska

    Native

    White non-Hispanic

    Black non-Hispanic

    Hispanic Asian PacificIslander

    Final Natality Statistics, 1996

    21%

    17%

    10%

    4% 3%

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    22/69

    Smoke-Free Families National Program Office

    Who Smokes before PregnancyBy Source of Care and Payment

    Source Percent

    Health Department 60%Medicaid (Any Source) 60%

    Private MD and Insurance 30%

    Adams from PRAMS

    S ki d i P

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    23/69

    Smoke-Free Families National Program Office

    Smoking during PregnancyBy Employment Status

    0

    5

    10

    15

    2025

    30

    35

    40

    4550

    CurrentS

    mokers%

    Lowest Highest

    Employment Grade

    35%

    25%

    15%

    10%8% 7%

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    24/69

    Smoke-Free Families National Program Office

    Smoking Prevalence in the USA

    20

    25

    3035

    40

    45

    5055

    60

    1950 1960 1970 1980 1990 2000

    Years

    Percentage

    Women

    Men

    JAMA, 1989:26

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    25/69

    Smoke-Free Families National Program Office

    Smoking Among Women

    In 1994, more than 14 million U.S.women aged 15-45 years were smokers

    800,000 to 1,000,000 of these womenbecome pregnant each year.

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    26/69

    Smoke-Free Families National Program Office

    Smoking during PregnancyLong-Term Effects on Woman

    Increased Decreased

    Cancer Life expectancy

    Heart DiseaseChronic Lung Disease

    Stroke

    142 000 Deaths Attributable to Cigarette Smoking

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    27/69

    Smoke-Free Families National Program Office

    142,000 Deaths Attributable to Cigarette Smokingin Women - United States, 1990

    36,000

    30,000

    10,000

    25,000

    8,000

    34,000

    CDC, MMWR, 8-27-93

    Ischemic Heart Disease Lung Cancer

    Stroke

    Chronic Lung DiseaseOther Diagnoses

    Other Cancers

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    28/69

    Smoke-Free Families National Program Office

    Diagnosis of Smoking

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    29/69

    Smoke-Free Families National Program Office

    Diagnosis of Smoking

    Deception rates, as confirmed by

    comparing results of biochemical

    tests with self-reports, are high.They may reach 50% in some

    populations.Alabama SCIP, 1998

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    30/69

    Smoke-Free Families National Program Office

    Diagnosis of Smoking

    Biologic markers are the goldstandard for diagnosing smoking or

    documenting cessation.

    A structured questionnaire correlates

    better with biologic markers than

    does asking a pregnant woman if she

    smokes and how much.

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    31/69

    Smoke-Free Families National Program Office

    Diagnosis of Smoking

    Biological Markers:

    Thiocyanate

    Cotinine

    Carbon Monoxide

    Urine

    orSaliva

    Measured in:

    Expired air

    Recommended

    Multiple Choice Question

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    32/69

    Smoke-Free Families National Program Office

    Recommended Multiple-Choice Question

    Which of the following statements best describes your

    cigarette smoking? Would you say:1. I smoke regularly now -- about the same amount as

    before finding out I was pregnant.

    2. I smoke regularly now, but Ive cut down since I foundout I was pregnant.

    3. I smoke every once in a while.

    4. I have quit smoking since finding out I was pregnant.

    5. I wasnt smoking around the time I found out I waspregnant, and I dont currently smoke cigarettes.

    Mullen et al., 1991

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    33/69

    Smoke-Free Families National Program Office

    Cessation and

    Treatment Programs

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    34/69

    Smoke-Free Families National Program Office

    Spontaneous Cessation

    Between 10 and 40% of pregnantsmokers quit spontaneously.

    The percentage depends on themothers age, race, education,

    duration and level of smoking.

    Self Initiated Rates of Cessation

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    35/69

    Smoke-Free Families National Program Office

    Self-Initiated Rates of Cessationamong Pregnant Women

    40% of pregnant women who areprivately insured quit smoking beforetheir first prenatal visit

    20% of pregnant women who arecovered by Medicaid quit smokingbefore their first prenatal visit

    Windsor, Li, Lowe, et al., 1993Ershoff, Mullen, Quinn, 1989

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    36/69

    Smoke-Free Families National Program Office

    Spontaneous Quitters

    Are less addicted

    Appear to be more concerned

    about effect of smoking on baby Have more years of school

    Smoking during Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    37/69

    Smoke-Free Families National Program Office

    Smoking during PregnancyPossible Interventions

    Clinical:cessation counseling &pharmacotherapies

    Community-based:

    mass media education

    Policy:tobacco taxes

    S ki C i

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    38/69

    Smoke-Free Families National Program Office

    Smoking Cessationduring Pregnancy

    Message from the Field

    We are funded and very anxious to

    do a smoking cessation programfor pregnant women, but we dontknow what to do.

    Healthy START ProgramSyracuse, NY, October 1998

    Smoking Cessation during Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    39/69

    Smoke-Free Families National Program Office

    Smoking Cessation during Pregnancy

    Clinical Cessation Programs

    Many different interventions have been used inan attempt to reduce or eliminate smoking inpregnancy:

    Physician Advice

    Self-help manuals and other printed materials

    Video-tapes

    Group clinics

    Psychotherapy

    S ki C i

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    40/69

    Smoke-Free Families National Program Office

    Smoking Cessation

    during Pregnancy

    ClinicalCessation Programs

    Many methods have not been tested

    rigorously in randomized trials.

    Most tested methods have notproduced a significant increase in

    cessation.

    Smoking Cessation during Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    41/69

    Smoke-Free Families National Program Office

    Smoking Cessation during Pregnancy

    Best Clinical Practice

    Meta-analyses reviewing smokingcessation studies have concluded that:

    For women smoking at the first prenatalvisit, the provision of a single 5-15 minutecounseling session by a trained providerplus appropriate print materials canincrease cessation rates from 5-10% to15-20%.

    Smoking Cessation during Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    42/69

    Smoke-Free Families National Program Office

    Smoking Cessation during Pregnancy5-15 Minute Counseling Session

    Determine amount smoked Review smoking-associated risks to

    fetus, infant and mother

    Review benefits to cessation Teach methods to stop smoking

    Ask for commitment to stop smoking

    Ask for commitment to use self-helpmanual

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    43/69

    Smoke-Free Families National Program Office

    Smoking Cessation

    during Pregnancy5-15 Minute Counseling Session

    The 5-15 minute counselingsession appears to work equally

    well with women of various

    ethnic and racial groups.

    Smoking Cessation during Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    44/69

    Smoke-Free Families National Program Office

    Smoking Cessation during Pregnancy

    Cessation Programs

    In pregnancy, less intensive advice has notsignificantly increased cessation over

    background.

    In pregnancy, more intensive interventionshave generally not increased cessation

    rates above those achieved using a 5-15

    minute counseling session by a trainedprovider.

    Smoking Cessation during Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    45/69

    Smoke-Free Families National Program Office

    Smoking Cessation during Pregnancy

    Current Barriers

    They question the effectiveness of counseling There are no specific ACOG recommendations

    Their staffs are untrained in this area

    There are too many intervention choices

    There is no reimbursement for counseling

    Other than advice to quit, most obstetric providersdo not include smoking cessation counseling

    among their services because:

    Smoking Cessation during Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    46/69

    Smoke-Free Families National Program Office

    Smoking Cessation during Pregnancy

    Print Materials

    Adverse effects of smoking onpregnancy

    Techniques to help quitting

    Benefits to be gained from quitting

    and for reducing smoking

    Print materials should be tailored forpregnancy and should present:

    Smoking Cessation

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    47/69

    Smoke-Free Families National Program Office

    gduring Pregnancy

    Provider Training A non-physician provider (nurse/

    nutritionist/social worker/etc.) can be

    trained and certified on site to screen andcounsel using self-instructional

    educational/training materials.

    The total time needed for this training isless than 3 hours.

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    48/69

    Smoke-Free Families National Program Office

    Implementing Cessation Programs

    Lessons Learned

    Execution matters

    Systems matter

    Incentives (to providers) work

    The Guide to Community Preventive Service

    Implemen

    ting Cessation Programs

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    49/69

    Smoke-Free Families National Program Office

    Implementing Cessation Programsin MCOs

    Develop administrative commitment Involve staff early in implementation

    planning

    Assign staff to monitor implementation Train clinical & support staff

    Adapt procedures to specific setting

    Evaluate and give feedback to staff

    Adapted from Make Yours a Fresh Start Family

    Cessation Programs

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    50/69

    Smoke-Free Families National Program Office

    Cessation Programs

    Cost - Effectiveness

    Using the 5-15 minute counselingsession plus print materials, various

    investigators have estimated that therewill be a $3 reduction in medical costsfor every $1 spent on the intervention.

    Smoking Cessation

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    51/69

    Smoke-Free Families National Program Office

    Smoking Cessation

    during PregnancyThe 5-15 minute counseling

    intervention has not significantlyincreased smoking cessation in

    heavy smokers.

    I t k b th NRT ( t h

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    52/69

    Smoke-Free Families National Program Office

    In non-pregnant smokers, both NRT (patch,gum, inhaler) and antidepressants

    (buproprion) approximately double cessationcompared to behavioral methods.

    In very limited studies in pregnant women,

    NRT was not associated with adverseoutcomes, but did have a short-term influenceon fetal breathing movements and fetal heartrate variability.

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    53/69

    Smoke-Free Families National Program Office

    There are no existing studies in which thesafety or efficacy of either antidepressants

    or NRT has occurred in a sufficiently large

    pregnant population to determine whatmight occur with large-scale use.

    Smoking Cessation during Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    54/69

    Smoke-Free Families National Program Office

    Smoking Cessation during Pregnancy

    Pharmacologic Interventions

    Since the heaviest smokers do not appearto respond well to behavioral interventionsused alone, the use of adjunctive

    pharmacologic approaches to achievecessation in these women should beexplored.

    The efficacy and safety of these

    pharmacological approaches duringpregnancy is unknown.

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    55/69

    Smoke-Free Families National Program Office

    Smoking Cessation

    during PregnancyPharmacologic Methods

    Nicotine ReplacementTherapy (NRT)

    Buproprion/Zyban

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    56/69

    Smoke-Free Families National Program Office

    Why Offer a SmokingCessation Program

    during Pregnancy?

    Substance Use in Past Month Among Women

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    57/69

    Smoke-Free Families National Program Office

    Aged 15-44 Years

    0

    5

    10

    15

    20

    25

    Prevalence(%)

    Cigarettes Alcohol Illicit Drugs

    National Household Survey on Drug Abuse, 1994-199

    20.6%

    2.4% 2.7%

    S ki C ti

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    58/69

    Smoke-Free Families National Program Office

    Smoking Cessationduring Pregnancy

    Stopping smoking is one of the

    few preventive measures likely

    to have a substantial impact on

    pregnancy outcome.

    Smoking Cessation

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    59/69

    Smoke-Free Families National Program Office

    Smoking Cessationduring Pregnancy

    Pregnant smokers who stopsmoking at any time up to the

    30th week of gestation haveinfants with higher birthweightthan women who smokethroughout pregnancy.

    Smoking Cessation

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    60/69

    Smoke-Free Families National Program Office

    gduring Pregnancy

    Reductionsin cigarette smoking

    documented by a decrease in

    cotinine or other biologic markers,or by self-report, have been

    associated with an increase in

    birth weight.

    Smoking Cessation

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    61/69

    Smoke-Free Families National Program Office

    S o g Cessat oduring Pregnancy

    Smoking cessation can also

    result in a permanent change

    in life-style that will reduce therisk of smoking-related

    chronic diseases.

    Postpartum Smoking Cessation

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    62/69

    Smoke-Free Families National Program Office

    0

    10

    20

    30

    40

    50

    60

    7080

    90

    100

    0 1 2 3 4 5 6Months from Delivery

    %

    Abstaining

    Mullen, 1990

    Smoking Cessationd i P

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    63/69

    Smoke-Free Families National Program Office

    during Pregnancy

    Postpartum Maintenance

    Womans health

    Next pregnancy

    Childs health

    Up to 35% of women who stopsmoking during pregnancy remain

    nonsmokers, benefiting:

    Smoking Cessation

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    64/69

    Smoke-Free Families National Program Office

    during Pregnancy

    Reduction of Medical Care Costs Direct health care costs

    prenataldelivery

    postnatal

    Indirect costsyears of life lost--infant mortality

    lost productivity of mother

    Smoking Cessationduring Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    65/69

    Smoke-Free Families National Program Office

    during PregnancyReduction of Medical Care Costs

    The excess cost of neonatal care for theinfant of a smoker averages $500

    Prenatal smoking interventions may yield a

    benefit-cost ratio of 3:1 for the initial hospitalstay and 6:1 using a longer time frame

    The break even point of prenatal smoking

    interventions is estimated to cost $32-$80

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    66/69

    Smoke-Free Families National Program Office

    The Future

    Goal

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    67/69

    Smoke-Free Families National Program Office

    Goal

    Achieve widest possible

    utilization by providers of an

    officially endorsed, pregnancy-specific, smoking cessation

    intervention

    Next Step

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    68/69

    Smoke-Free Families National Program Office

    Next Step

    Private providers Public providers

    Managed care providers

    Develop a dissemination strategyto achieve maximum utilization ofthe intervention by:

    Smoking Cessation during Pregnancy

  • 7/30/2019 Dangers of Smoking Before, During and After Pregnancy

    69/69

    Smoke-Free Families National Program Office

    Dissemination Goal

    Dissemination by the CDC and other federalagencies, ACOG, and the RWJF TobaccoControl initiatives has the potential to

    achieve a nationwide adoption of a single,pregnancy-specific, smoking cessationintervention to be delivered by all providers,thereby setting the standard of care for

    pregnant smokers.