RecruitingPhase 4NCT04783857

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

Sponsor

University of Minnesota

Enrollment

279 participants

Start Date

Apr 14, 2022

Study Type

INTERVENTIONAL

Conditions

Smoking Smoking Cessation Smoking Reduction

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria9

Ability to provide informed consent,
Aged 18 to 45 years old
Self-reported stable physical and mental health
self-report uncomplicated pregnancy at gestational week 30 or beyond, or
self-report the birth of a child within the past 6 months
History of ≥ 4 cigarettes per month during the six months prior to pregnancy
At enrollment, self-report of motivation to become and/or remain abstinent after delivery ≥ 6 on a 10 point Likert-type scale
Willingness to protect against pregnancy following day 0 to week 12 of the study
Participants must live in the continental US and have a device to fully participate in the protocol

Exclusion Criteria5

Current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes
Current major depressive disorder based on the Patient Health Questionnaire-9 (PHQ-9) and the Beck Depression Inventory
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),
Current or within the past 3 months treatment for illicit drug use or alcohol use
Any condition or issue that, in the opinion of the clinical team, precludes participation in the trial.

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