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

NCT04783857 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 279

Last updated 2025-07-08

No results posted yet for this study

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.

Conditions

  • Smoking
  • Smoking Cessation
  • Smoking Reduction

Interventions

DRUG

Progesterone 200 MG Oral Capsule

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

Sponsors & Collaborators

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

    collaborator NIH

  • University of Minnesota

    lead OTHER

Principal Investigators

  • Sharon Allen, MD, PhD · University of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2026-06-02
Completion
2026-06-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04783857 on ClinicalTrials.gov