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Completed

NCT Number: NCT01210118

Interventions of Smoking Cessation During Pregnancy

The aim of this clinical trial is to test whether offering pregnant smokers a high intensity intervention for smoking cessation increases the rate of smoking cessation at the third trimester of pregnancy, compared to low intensity intervention for smoking cessation that is the usual care, control condition.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Peripheral General Hospital-Maternity Helena Venizelos, Athens, Attica, Greece

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About this study

This is a randomized controlled trial that compares the efficacy of a proactive pregnancy-tailored high intensity intervention for smoking cessation, with a usual care low intensity intervention, that is the control condition.

Intervention group participants will receive a high intensity intervention, which includes: 30 minutes of cognitive-behavioural intervention delivered by a trained health care professional through out the first 24 weeks of gestation and a self-help manual especially tailored for smoking cessation during pregnancy. Control group participants will receive 5 minutes of low intensity intervention.

Participants' smoking status will be biochemically validated with urine cotinine and nicotine both at the baseline and at the 32nd week of gestation, expired carbon monoxide (CO) will be measured only at the baseline. After childbirth the infants' birth weight, the premature birth and any other complications in pregnancy and childbirth will be recorded. No medication is going to be used.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women
  • current cigarette smoker (smoked >5 cigarettes in the past 7 days)
  • 18 years old or older

Exclusion criteria

  • More than 24 weeks' gestation at study entry
  • No telephone access
  • Not planning to live in Athens for 1 year
  • Unable to read and speak Greek
  • Alcoholics
  • Use of drug substances
  • Depression

Treatment and study plan

Low Intensity Intervention

Behavioral

Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.

Higher intensity intervention

Behavioral

Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the "5 Αs" (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided.

Other names: Experimental group

Primary outcomes

  1. Participants' Smoking Status

    Time frame: around the 32nd week of gestation.

    participants' smoking status was validated by urine cotinine and urine nicotine

  2. The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.

    Time frame: At the baseline and at the 32nd week of gestation

    The basic primary outcomes of the study present the levels of urine cotinine before and after intervention separately for each group according to the cut of point that is used for the separation of active from passive smoking ,when urine cotinine ≤80ng/ml: there is biochemically validated smoking cessation.

Secondary outcomes

  1. Birth Weight

    Time frame: After child birth

    Infants' birth weight was recorded.

  2. Days of Prematurity of Birth

    Time frame: After child birth

    Days of prematurity of birth were recorded

Sponsors and collaborators

Lead sponsor

Hellenic Anticancer Society

Other

Collaborators

  • National and Kapodistrian University of Athens

Registry information

Official study title

The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 28, 2010
Registry last updated
Apr 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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