CompletedNot Applicable

Progesterone & Postpartum Relapse to Smoking

United States46 participantsStarted 2014-06

Plain-language summary

The primary goal of this project is to investigate the potential efficacy of exogenous progesterone (with supplemental relapse prevention counseling) on postpartum relapse in new mothers. Also to determine the feasibility of enhanced compliance monitoring and identification of collateral factors effecting outcomes.

Who can participate

Age range

18 Years – 35 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: * Woman * 18-35 years old * Zero CPD for past 4 weeks * 5 or more CPD for at least 6 out of past 12 months * Motivated to remain abstinent (7 or higher out of 10) * Stable physical/mental health * Established prenatal care * Stable physical/mental health * Willing to take Progesterone * Willing to use double-barrier protection if sexually active * English fluency * Able to provide informed consent Exclusion Criteria: * Psychotropic medications * Illicit drugs * Other types of tobacco, NRT, smoking cessation medications * Pregnancy complications (Diabetes, Anomaly, Fetal growth restriction, HTN, Hx of \>2 miscarriages) * Current use of: Finasteroid (propecia), Efavirenz, Red Clover, Ketoconazole, CYP3A4 Inhibitors * History of: Thrombophelitis, Deep vein thrombosis, Pulmonary embolus, Clotting disorder, Bleeding disorder, Heart disease, Diabetes, Stroke, Peanut allergy, Liver dysfunction, Hypersensitivity to progesterone

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Number of Participants Who Relapsed by Week 4 Postpartum

Timeframe: Week 4 Postpartum

Trial details

NCT IDNCT01798394

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

Results submitted2016-07-26

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