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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Progesterone 200 MG Oral Capsule

    Drug

    Progesterone, 200mg, once daily, oral tablet/capsule

Treatment groups

171 Participants
are divided into 2 treatment groups
Group A: Group 1Active comparator 1 intervention
Group B: Group 2No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Smoking abstinence at Month 6

Time frame
6 months
2

Child health assessed as smoke exposure and acute infant health.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

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

Collaborator