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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Minnesota

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Progesterone 200 MG Oral Capsule

Treatment groups

171 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Minnesota

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator