Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-28 @ 2:59 PM
Study NCT ID:
NCT04783857
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2021-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
Sponsor:
University of Minnesota
Organization:
Study Overview
Official Title:
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HD100418 | NIH | None | https://reporter.nih.gov/quic… | View |