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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Trial status changed: Active, Not Recruiting → Recruiting
    • Site details revised
    v12
  2. Primary and study completion dates: Jun 2, 2026 to Jun 2, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 279 to confirmed 171
    • Site details revised
    v11
  3. Primary and study completion dates: Jun 2, 2025 to Jun 2, 2026v10
  4. Re-verified, no change to tracked fieldsv9
  5. Primary endpoints: 3 to 2v8 Show 6 more changesShow less
    • Enrollment target: 312 to 279
    • Study sites: 2 to 1
    • Interventions: Placebo Oral Tablet (Other), Progesterone 200 MG Oral Capsule (Drug) to Progesterone 200 MG Oral Capsule (Drug)
    • Eligibility criteria shortened, about 51 words
    • Study description expanded, about 22 words
    • Collaborators: 2 to 1
Show 6 earlier versionsHide 6 earlier versions
  1. Interventions: Depot-Medroxyprogestereone Acetate (Drug), Placebo Injection (Other), Placebo Oral Tablet (Other), Progesterone 200 MG Oral Capsule (Drug) to Placebo Oral Tablet (Other), Progesterone 200 MG Oral Capsule (Drug)
    • Eligibility criteria expanded, about 30 words
    • Study arms: 4 to 2
    • Study description shortened, about 4 words
    v7
  2. Primary endpoints revised (3)v6
  3. Primary completion date: Sep 30, 2024 to Jun 2, 2025
    • Start date: May 15, 2021 to Apr 14, 2022
    v5
  4. Study sites: 1 to 2v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 24, 2021 to May 15, 2021
    v3
  6. Primary completion date: Apr 2021 to Sep 30, 2024
    • Study completion date: Apr 2021 to Jun 2, 2025
    • Start date: Apr 2021 to May 24, 2021
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04783857
Lead Sponsor University of Minnesota
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Smoking, Smoking Cessation, Smoking Reduction
Related terms Smoking, Smoking Cessation, Smoking Reduction
Enrollment 171 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov