Phase 1 N=92 Randomized Single-blind Prevention

Interventions of Smoking Cessation During Pregnancy

Smoking Cessation

Bottom Line

View on ClinicalTrials.gov: NCT01210118 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2013

Primary outcome: Primary: Participants' Smoking Status — 253.6; 678.9; 311.9; 479.6 ng/ml

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Low intensity intervention (Behavioral); Higher intensity intervention (Behavioral)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Hellenic Anticancer Society
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants' Smoking Status	253.6; 678.9; 311.9; 479.6	—
PRIMARY The Effectiveness of the Interventions According the Levels of Urine Cotinine Before and After Intervention.	11.9; 21.4; 45.2; 21.4	—
SECONDARY Birth Weight	3,003.4; 3,231.3	—
SECONDARY Days of Prematurity of Birth	14.3; 10.5	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01210118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.