Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and R… (NCT04783857) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
United States171 participantsStarted 2022-04-14
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. self-report uncomplicated pregnancy at gestational week 30 or beyond, or
. self-report the birth of a child within the past 6 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on postpartum women who smoke — given that it's already in Phase 4 and no longer recruiting, is there any way for me to still participate, or should we be looking at other active studies for postpartum smoking cessation?
2The trial involves modifying progesterone and estradiol levels after giving birth — what are the potential risks of hormonally-based treatments during the postpartum period, especially if I'm breastfeeding?
3One of the things this study is measuring is my baby's secondhand smoke exposure and acute health outcomes — are there evidence-based strategies I could start now to reduce my infant's smoke exposure while we figure out the best long-term cessation plan?
4Since this is a Phase 4 trial, it's testing something further along in the research process — does that mean the hormonal approach being studied here has more established safety data than earlier-phase trials, and how does that compare to standard postpartum smoking cessation options you'd recommend for me?
5The trial tracks smoking abstinence at six months postpartum — what does the current evidence say about the hardest points of relapse after giving birth, and how would this kind of hormonal intervention fit alongside other support like counseling or nicotine replacement therapy?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Smoking abstinence at Month 6
Timeframe: 6 months
2
Child health assessed as smoke exposure and acute infant health.