NCT04783857

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 279 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This Good Clinical Practice clinical trial will be implemented by an experienced, transdisciplinary, and productive team of investigators to enhance the diversity of the study sample and generalizability of results. We will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US) and will participant in an observational arm of the study. Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. All participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.

Conditions

• Smoking
• Smoking Cessation
• Smoking Reduction

Interventions

Type	Name	Description
DRUG	Progesterone 200 MG Oral Capsule	Progesterone, 200mg, once daily, oral tablet/capsule

Timeline

• Start date: 2022-04-14
• Primary completion: 2026-06-02
• Completion: 2026-06-02
• First posted: 2021-03-05
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study