GN Tobacco Use Survey

Sponsor

NICHD Global Network for Women's and Children's Health (Other)

Overall Status

Completed

CT.gov ID

NCT00121368

Collaborator

National Cancer Institute (NCI) (NIH), Global Network for Women's and Children's Health Research (Other), Bill and Melinda Gates Foundation (Other), Fogarty International Center of the National Institute of Health (NIH), National Center for Complementary and Integrative Health (NCCIH) (NIH), National Institute of Dental and Craniofacial Research (NIDCR) (NIH), RTI International (Other)

6,000

Enrollment

Locations

14.9

Duration (Months)

666.7

Patients Per Site

44.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking

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%.

Study Design

Study Type:

Observational

Actual Enrollment :

6000 participants

Time Perspective:

Prospective

Official Title:

Survey on Tobacco Use in the GN Sites

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

Tobacco use [Cross sectional]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	City	State	Country
1	Buenos Aires		Argentina
2	Recife		Brazil
3	Kinshasa		Congo
4	Quito		Ecuador
5	Guatemala City		Guatemala
6	Bhubaneswar	Orissa	India
7	Belgaum		India
8	Karachi		Pakistan
9	Lusaka		Zambia