[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606384":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":53,"collaborators":55,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Ibis Reproductive Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Combined regimen","ACTIVE_COMPARATOR","Participants in this arm are randomized to receive the standard of care combined mifepristone + misoprostol regimen. Specifically, for those with pregnancies \\\u003C64 days, mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b\u002Fv); for those 64-77 days, they will take a second dose of misoprostol (800μg b\u002Fv) taken 3 hours later.",[13],"Drug: Combined regimen",{"label":15,"type":16,"description":17,"interventionNames":18},"Misoprostol-only","EXPERIMENTAL","Participants in this arm will be randomized to receive a misoprostol-only regimen. Specifically, 3-4 doses of 800μg misoprostol administered sublingually every 3 hours.",[19],"Drug: Misoprostol-only medication abortion regimen",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Misoprostol-only medication abortion regimen","This intervention is an updated misoprostol-only regimen that involves being counseled on and receiving medications for a medication abortion using 3-4 doses of 800μg misoprostol administered sublingually every 3 hours.",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"This intervention will involve participants being counseled on and receiving medications for a medication abortion regimen of mifepristone (200mg orally) followed 24-48 hours later by misoprostol (800μg b\u002Fv) with a second dose of misoprostol (800μg b\u002Fv) taken 3 hours later only for those 64-77 days.",[9],[31],{"facility":32,"status":26,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Planned Parenthood Association of Utah","Salt Lake City","Utah","84102","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-111.89105,40.76078,{"lat":42,"lon":41},[45,50],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Director of Research","CONTACT","885-355-1875","Priscila.Monteiro@ppau.org",{"name":51,"role":52,"phone":26,"phoneExt":26,"email":26},"Lori Gawron, MD","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[56,58],{"name":57,"class":6},"University of Utah",{"name":32,"class":59},"UNKNOWN","100606384","phase-4-the-misoprostol-only-regimen-evidence-study-100606384",false,"NCT07174856","The Misoprostol-Only Regimen Evidence Study","The Misoprostol-Only Regimen Evidence (MORE) Study: A Randomized Controlled Trial Comparing the Misoprostol-only Regimen Versus the Combined Mifepristone and Misoprostol Regimen for Medication Abortion","MORE","Inclusion Criteria:\n\n* Pregnancy of \\\u003C or = 77 days duration based on LMP or ultrasound\n* Positive pregnancy test (self-report or in-clinic)\n* Age: States without parental involvement laws : in-person patients ages 14 years and older; States with parental involvement or notification laws: 18 years or older\n* Willing and able to give informed consent\n* Willing to comply with study protocol\n* Willing to record requested information in the study surveys\n* English or Spanish speaking\n* Has a text message, email, or phone call capable device for survey completion\n* Understands and signs an Institutional Review Board (IRB) approved informed consent form prior to undergoing any study procedures or randomization\n\nExclusion Criteria:\n\n* concurrent participation in any other interventional trial\n* unwilling to comply with the study protocol and survey\u002Fvisit schedule\n* contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)\n* contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)\n* cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)\n* diagnosis of porphyria\n* known bleeding disorder or receiving anticoagulants\n* pregnancy with an IUD in place\n* diagnosis of pregnancy of unknown location (PUL), early pregnancy failure, incomplete or inevitable abortion (absent gestational sac and\u002For open cervical os)\n* possibility of ectopic pregnancy\n* known or suspected pelvic infection\n* Have issues or concerns (in the judgement of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.\n* Have previously participated in the study\n* Be a site staff member with delegated study responsibilities or a family member of, or have a close relationship with, a site staff member with delegated study responsibilities.","FEMALE","14 Years",{"count":71,"type":72},1900,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","The goal of this study is to evaluate the effectiveness, non-inferiority, and side-effect profile of an updated misoprostol-only regimen, as compared to the combined mifepristone-misoprostol regimen, among people seeking medication abortion (MAB) through 77 days of pregnancy in telehealth and in-person settings. The investigators aim to evaluate this in both in-clinic and telehealth medication abortion care in the United States.\n\nThe main questions it aims to answer are:\n\n1. What proportion of pregnant people using an updated misoprostol-only medication abortion regimen have a complete abortion using just the prescribed pills?\n2. Is the updated misoprostol-only medication abortion regimen no more than 5% less effective (non-inferior) than the standard combined medication abortion regimen?\n3. What is the pattern of beta hCG decline following use of a misoprostol-only medication abortion through 77 days of pregnancy?\n\nParticipants will:\n\n* be randomized to one of two medication regimens (misoprostol-only or the combined regimen) in a 1:1 ratio based on duration of pregnancy at enrollment. - self-report outcomes via daily surveys for the first 3 days, and thereafter weekly at 7, 14, 21, 28, and 35 days.\n* return to the clinical site for tests as instructed\n\nThe investigators hypothesize that the proportion with complete abortions in the misoprostol-only arm will be non-inferior to the proportion with complete abortions in the combined regimen arm within a 5% margin of inferiority",[78],"Abortion, Medical",[80,81,82],"misoprostol","mifepristone","medication abortion","NOT_YET_RECRUITING","2025-10-03",{"date":86,"type":87},"2025-10-08","ACTUAL",{"date":89,"type":72},"2025-10-10",{"date":91,"type":72},"2027-03",{"name":5,"class":6},1]