Clinical trial NCT00121368: GN Tobacco Use Survey
Official title: Survey on Tobacco Use in the GN Sites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Keywords: Global Network
Maternal and child health
International
Women's health
Tobacco
Smoking
Africa
Latin America
South America
Guatemala
Zambia
India
Argentina
Democratic Republic of the Congo
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Global Network for Women's and Children's Health Research
name: Bill and Melinda Gates Foundation
name: Fogarty International Center of the National Institute of Health
name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: RTI International
First posted: 2005-07-21
Enrollment: 6000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women 18-45

Brief summary: Smoking can contribute to many health problems for mothers and their babies. In developing countries, there is little information about the number of pregnant women that smoke and the reasons why some pregnant women choose to smoke. The purpose of this multi-site tobacco use survey is to obtain information on knowledge, attitudes and behaviors among pregnant women in diverse populations regarding tobacco products.

Detailed description: Smoking is regarded as one of the few potentially preventable factors associated with low birth weight, very preterm birth and perinatal death. In an effort to determine the prevalence of tobacco use (smoking and smokeless tobacco) and to collect relevant data in support of a potential smoking prevention or cessation intervention, a multi-site tobacco use survey is being conducted in several countries. The survey will be used to obtain information on knowledge, attitudes and behaviors among pregnant women in diverse populations regarding tobacco products.

The primary outcome is tobacco use status during pregnancy. Secondary outcomes include: knowledge and attitudes regarding tobacco products, health hazards of tobacco use and environmental tobacco smoke (ETS) exposure.

Sample size of 750 per country was calculated under the assumptions that the prevalence of tobacco use could be as low as 0.05 with a coefficient of variation of approximately 15% and a prevalence of 0.10 with a CV of approximately 11%.

Eligibility criteria: Inclusion Criteria:

* Pregnant women of legal consent and child-bearing age (18-45)
* Attendance at a participating clinic

Exclusion Criteria:

* Pregnant women with disabilities such as deafness, serious mental illness, or mental retardation

Primary outcomes:
measure: Tobacco use
timeFrame: Cross sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Recife
country: Brazil
city: Kinshasa
country: Congo
city: Quito
country: Ecuador
city: Guatemala City
country: Guatemala
city: Bhubaneswar
country: India
state: Orissa
city: Belgaum
country: India
city: Karachi
country: Pakistan
city: Lusaka
country: Zambia
Study officials:
affiliation: National Cancer Institute (NCI)
name: Michele Bloch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: