GN Tobacco Use Survey

Smoking Clinical Trial

Official title:

Survey on Tobacco Use in the GN Sites

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121368
• Other study ID #: CP01 Tobacco Use
• Status: Completed
• Phase: N/A
• First received: July 15, 2005
• Last updated: November 22, 2013
• Start date: February 2004
• Est. completion date: May 2005

Study information

• Verified date: November 2013
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
NICHD Global Network for Women's and Children's Health	Bill and Melinda Gates Foundation, Global Network for Women's and Children's Health Research, John E. Fogarty International Center (FIC), National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), RTI International

Countries where clinical trial is conducted

Argentina,  Brazil,  Congo,  Ecuador,  Guatemala,  India,  Pakistan,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use		Cross sectional	No

External Links

•   Global Network for Women's and Children's Health