Clinical trial NCT01210118: Interventions of Smoking Cessation During Pregnancy
Official title: The Effectiveness of High and Low Intensity Intervention for Smoking Cessation During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: Pregnancy
Smoking cessation
Cognitive-Behavioural interventions
Lead sponsor: Hellenic Anticancer Society
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2010-09-28
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participants' Smoking Status
timeFrame: around the 32nd week of gestation.
measure: The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.
timeFrame: At the baseline and at the 32nd week of gestation
Secondary outcomes:
measure: Birth Weight
timeFrame: After child birth
measure: Days of Prematurity of Birth
timeFrame: After child birth
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Peripheral General Hospital-Maternity Helena Venizelos
state: Attiki
city: Haidari
country: Greece
facility: Maternity Unit of ATTIKON University Hospital
state: Attiki
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Panagiotis K Behrakis, Professor
role: STUDY_CHAIR
affiliation: National and Kapodistrian University of Athens
name: Andriani N Loukopoulou, PhD pending
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loukopoulou A N, Evangelopoulou V, Behrakis P K.Smoking and pregnancy. Pneumon 23(2):160-167,2010.
citation: Loukopoulou AN, Vasiliou MP, Behrakis PK. (2011) Interventions for smoking cessation during Pregnancy Pneumon, 24(1):381-391(Review).
citation: Loukopoulou AN, Vardavas CI, Farmakides G, Rossolymos C, Chrelias C, Tzatzarakis MN, Tsatsakis A, Lymberi M, Connolly GN, Behrakis PK. Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE). BMC Public Health. 2011 Dec 6;11:903. doi: 10.1186/1471-2458-11-903.
citation: Loukopoulou AN, Vardavas CI, Farmakides G, Rosolymos C, Chrelias C, Tzatzarakis M, Tsatsakis A, Myridakis A, Lyberi M, Behrakis PK. Counselling for smoking cessation during pregnancy reduces tobacco-specific nitrosamine (NNAL) concentrations: A randomized controlled trial. Eur J Midwifery. 2018 Nov 14;2:14. doi: 10.18332/ejm/99546. eCollection 2018.