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OpenTrials
Completed

NCT Number: NCT00121368

GN Tobacco Use Survey

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Buenos Aires, Argentina

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About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Tobacco use

    Time frame: Cross sectional

Sponsors and collaborators

Lead sponsor

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

Network

Collaborators

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

Registry information

Official study title

Survey on Tobacco Use in the GN Sites

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Jul 21, 2005
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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