Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

• Status: Recruiting
• Trial end date: 2025-06-02
• Target enrollment: 0
• Participant gender: Female

Summary

The investigators aim to address the following specific aims:

• Determine the efficacy of Prog/DMPA 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Arizona
• Treatments: Medroxyprogesterone; Medroxyprogesterone Acetate; Progesterone

Criteria

Inclusion Criteria:

• stable physical and mental health with confirmed, uncomplicated pregnancy at gestational week 30-35

• established prenatal care with written approval to participate fully in the study from their prenatal healthcare provider

• self-report of a minimum of 4 weeks of smoking abstinence with confirmation of acute abstinence by expired carbon monoxide level of ≤ 5 ppm at the time of enrollment

• history of ≥ 5 cigarettes a day for at least 6 out of the last 12 months

• self-report of motivation to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale

• willingness to use non-hormonal contraceptives postpartum if sexually active until 12 weeks postpartum

Exclusion Criteria:

• current use of tobacco products (e.g., cigars, e-cigs), nicotine replacement therapy or smoking cessation medications

• current major depressive disorder based on the Structured Clinical Interview for DSM-5 (SCID)

• contraindication to progesterone treatment (e.g., current use of drugs that may inhibit CYP3A4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy)

• contraindications to DMPA treatment (e.g., current use of aminoglutethimide or planning to become pregnant in the next year)

• current use of illicit drugs or alcohol abuse

• treatment for illicit drug use or alcohol use disorder within the last 3 months

• any condition that, in the opinion of the clinical team, precludes participation in the trial.