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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT04783857
Phase
PHASE4
Status
Recruiting
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Conditions

  • Smoking
  • Smoking Cessation
  • Smoking Reduction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Progesterone 200 MG Oral Capsule — DRUG
    Progesterone, 200mg, once daily, oral tablet/capsule

Study Details

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.

Key Dates

First listed
Mar 5, 2021
Start date
Apr 14, 2022
Status verified
Jul 2026
Primary completion
Jun 2, 2027
Completion
Jun 2, 2027

Study Design

Enrollment
171 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Group 1
    Participants in this group will receive progesterone
  • No Intervention: Group 2
    Participants in this group will not receive progesterone

Primary Outcome Measure

Smoking abstinence at Month 6 [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Katherine Harrison, MPH

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By research site
University of Minnesota· Minneapolis, MN

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