Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-25 @ 3:59 PM
Study NCT ID:
NCT00121368
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2005-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GN Tobacco Use Survey
Sponsor:
NICHD Global Network for Women's and Children's Health
Organization:
Study Overview
Official Title:
Survey on Tobacco Use in the GN Sites
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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%.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: