GN Tobacco Use Survey

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00121368
First received: July 15, 2005
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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
Smoking

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Survey on Tobacco Use in the GN Sites

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Tobacco use [ Time Frame: Cross sectional ] [ Designated as safety issue: No ]

Enrollment: 6000
Study Start Date: February 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women 18-45

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121368

Locations
Argentina
Buenos Aires, Argentina
Brazil
Recife, Brazil
Congo
Kinshasa, Congo
Ecuador
Quito, Ecuador
Guatemala
Guatemala City, Guatemala
India
Bhubaneswar, Orissa, India
Belgaum, India
Pakistan
Karachi, Pakistan
Zambia
Lusaka, Zambia
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
Investigators
Principal Investigator: Michele Bloch, MD, PhD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00121368     History of Changes
Other Study ID Numbers: CP01 Tobacco Use
Study First Received: July 15, 2005
Last Updated: November 22, 2013
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
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

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014