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Smoking Cessation Interventions for Pregnant Women
N/A
Recruiting
Led By Jan Blalock
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial seeks to help low-income pregnant women quit smoking. Smoking during pregnancy is associated with an increased risk of low birth weight, which can lead to health problems for the baby.
Who is the study for?
This trial is for low-income pregnant women in Northeast Texas who smoke or allow smoking at home. It's also open to household members who smoke. Participants must be receiving services from WIC or FQHC clinics, consent to surveys, and speak English or Spanish.
What is being tested?
The study tests a program designed to help pregnant women quit smoking through counseling, telephone support, educational materials, and surveys. The goal is to reduce cancer risks associated with smoking and improve birth outcomes.
What are the potential side effects?
There are no direct medical side effects from participating as the interventions involve counseling and information provision rather than medication. However, quitting smoking can lead to withdrawal symptoms like irritability and cravings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2019 Phase 2 trial • 107 Patients • NCT009835804%
Tinnitus
2%
Rectal pain
2%
Pain
2%
Hearing test abnormal
2%
Rectal hemorrhage
2%
Dizziness
2%
Gastrointestinal disorder
2%
Headache
2%
Musculoskeletal disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Acetylsalicylic Acid and Eflornithine)
Arm II (Placebo)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Goal 4 (counseling)Experimental Treatment4 Interventions
Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period.
Group II: Goal 3 (Smoke-free Homes)Experimental Treatment5 Interventions
Participants receive the Smoke-Free Homes kit providing guidance for how to talk with household members and visitors about not smoking inside the home. Participants may also receive 3 separate Smoke-Free Homes mailings over 6 weeks, and a coaching call from a Baby Steps for Health counselor to help follow the steps described in the mailed materials in order to set up a smoke-free home.
Group III: Goal 2 (counseling, Wellness app, self-help)Experimental Treatment6 Interventions
Participants receive telephone counseling sessions over 30-45 minutes for a minimum of 6 sessions in the prenatal period and about 4-6 postpartum period. Participants who start counseling after birth, may receive 6-8 sessions up to 4 months postpartum. Participants may also use the Pregnancy and Wellness smartphone app that provides wellness messages, smoking cessation information, relapse prevention tips, and tips to create a smoke-free home. Participants also receive tobacco cessation self-help materials including National Partnership for Smoke Free Families and Forever Free Baby and Me.
Group IV: Goal 1 (Wellness app)Experimental Treatment4 Interventions
Participants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telephone-Based Intervention
2017
Completed Phase 2
~3400
Smoking Cessation Intervention
2005
N/A
~1820
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,749,387 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,058,422 Total Patients Enrolled
Jan BlalockPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
99 Total Patients Enrolled