Actively Recruiting
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
Led by University of Minnesota · Updated on 2025-07-08
279
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
U
University of Minnesota
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators aim to address the following specific aims: * Determine the efficacy of Prog in preventing postpartum smoking relapse and reducing smoking relapse risk factors. * Examine the effects of this maternal smoking intervention on infant health. * Examine racial and ethnic differences in intervention outcomes.
CONDITIONS
Official Title
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent
- Between 18 and 45 years old
- Self-reported stable physical and mental health
- Currently pregnant at 30 weeks or more, or gave birth within the past 6 months
- Smoked at least 4 cigarettes per month in the six months before pregnancy
- Motivated to stay abstinent after delivery with a score of 6 or higher on a 10-point scale
- Willing to use birth control from day 0 to week 12 of the study
- Lives in the continental US and has a device to participate fully
You will not qualify if you...
- Daily use of nicotine replacement or smoking cessation medications, except e-cigarettes
- Current major depressive disorder based on PHQ-9 and Beck Depression Inventory
- Contraindications to progesterone treatment including certain medications, blood clots, heart or liver conditions, or peanut allergy
- Treatment for illicit drug or alcohol use in the past 3 months
- Any condition that the clinical team believes prevents participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
K
Katherine Harrison, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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