[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053612":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":53,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":18,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":18,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Minnesota","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1","ACTIVE_COMPARATOR","Participants in this group will receive progesterone",[13],"Drug: Progesterone 200 MG Oral Capsule",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2","NO_INTERVENTION","Participants in this group will not receive progesterone",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Progesterone 200 MG Oral Capsule","Progesterone, 200mg, once daily, oral tablet\u002Fcapsule",[9],[26],{"name":27,"affiliation":5,"role":28},"Sharon Allen, MD, PhD","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":18,"email":34},"Katherine Harrison, MPH","CONTACT","612-624-5377","harr0644@umn.edu",[36],{"facility":5,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-93.26384,44.97997,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":18,"phoneExt":18,"email":18},{"type":52,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[54],{"name":55,"class":56},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100053612","phase-4-modifying-progesterone-and-estradiol-levels-to-prevent-postpartum-cigarette-smoking-relapse-and-reduce-secondhand-smoke-exposure-in-infants-and-children-100053612",false,"NCT04783857","Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children","Inclusion Criteria:\n\n* Ability to provide informed consent,\n* Aged 18 to 45 years old\n* Self-reported stable physical and mental health\n\n  1. self-report uncomplicated pregnancy at gestational week 30 or beyond, or\n  2. self-report the birth of a child within the past 6 months\n* History of ≥ 4 cigarettes per month during the six months prior to pregnancy\n* At enrollment, self-report of motivation to become and\u002For remain abstinent after delivery ≥ 6 on a 10 point Likert-type scale\n* Willingness to protect against pregnancy following day 0 to week 12 of the study\n* Participants must live in the continental US and have a device to fully participate in the protocol\n\nExclusion Criteria:\n\n* Current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes\n* Current major depressive disorder based on the Patient Health Questionnaire-9 (PHQ-9) and the Beck Depression Inventory\n* Contraindication to progesterone treatment (e.g., current use of drugs that may inhibit CYP3A4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy),\n* Current or within the past 3 months treatment for illicit drug use or alcohol use\n* Any condition or issue that, in the opinion of the clinical team, precludes participation in the trial.","FEMALE","18 Years","45 Years",{"count":67,"type":68},171,"ESTIMATED","INTERVENTIONAL",[71],"PHASE4","The investigators aim to address the following specific aims:\n\n* Determine the efficacy of Prog in preventing postpartum smoking relapse and reducing smoking relapse risk factors.\n* Examine the effects of this maternal smoking intervention on infant health.\n* Examine racial and ethnic differences in intervention outcomes.",[74,75,76],"Smoking","Smoking Cessation","Smoking Reduction","2026-07-09",{"date":79,"type":80},"2026-07-13","ACTUAL",{"date":82,"type":80},"2022-04-14",{"date":84,"type":68},"2027-06-02",{"name":5,"class":6},1]