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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 2 trial • 107 Patients • NCT00983580

Tinnitus

Rectal pain

Pain

Hearing test abnormal

Rectal hemorrhage

Dizziness

Gastrointestinal disorder

Headache

Musculoskeletal disorder

100%

80%

60%

40%

20%

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

~1800