- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03104452
Helping Moms Who Smoke
August 24, 2021 updated by: University of Kansas Medical Center
Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change
The purpose of this study is to learn how women's smoking changes during their pregnancy and as a new mom, and to assess the help they receive from their health care providers.
Study Overview
Status
Completed
Conditions
Detailed Description
Approximately 90% of women who smoked before pregnancy will be smokers within one year of delivery .
This occurs even though half who smoke quit during the course of pregnancy.
This is an observational, cohort study of pregnant women who smoked in the six months before becoming pregnant.
Women will be followed from the first trimester to one year after the birth of their babies.
The results of this study will help us to describe women's' views on the quality of tobacco counseling they receive from their doctors; understand patterns of smoking and quitting throughout pregnancy and after childbirth; and provide information needed to develop an intervention to help women quit.
Study Type
Observational
Enrollment (Actual)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited from obstetric and family practice clinics identified by the researchers.
Description
Inclusion Criteria:
- Smoked within six months prior to becoming pregnant or current smoking
- Smoked at least 100 cigarettes
- Pregnant
- English speaking
- Access to a cell phone
- Willing to receive and send text messages.
Exclusion Criteria:
- Quit for longer than 6 months before becoming pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Pregnant Smokers
Participants are pregnant women who smoked in the six months prior to their pregnancy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking status
Time Frame: 1 year post-partum
|
The investigators will assess 7-day point prevalence smoking status over multiple time-points over the study period
|
1 year post-partum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Taneisha Scheuermann, PhD, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
July 31, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
April 3, 2017
First Submitted That Met QC Criteria
April 6, 2017
First Posted (Actual)
April 7, 2017
Study Record Updates
Last Update Posted (Actual)
August 26, 2021
Last Update Submitted That Met QC Criteria
August 24, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- K01DA040745 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
National University of SingaporeRecruitingSmoking &Amp; Tobacco CessationSingapore
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Sultan Qaboos UniversityCompletedSmoking Cessation | Tobacco Use Cessation | Smoking PreventionOman
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedSmoking &Amp; Tobacco CessationUnited States
-
The University of Hong KongCompletedSmoking Cessation Counseling Ability | Smoking Cessation Counseling PracticeHong Kong