{"id":"dinoprostone-vaginal-insert","safety":{"commonSideEffects":[{"rate":null,"effect":"Uterine hyperstimulation"},{"rate":null,"effect":"Vaginal pain or irritation"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Back pain"}]},"_chembl":{"chemblId":"CHEMBL548","moleculeType":"Small molecule","molecularWeight":"352.47"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Dinoprostone acts as a direct agonist of prostaglandin E (EP) receptors, particularly EP1 and EP3 receptors on uterine smooth muscle and cervical tissue. This binding triggers increased intracellular calcium and myometrial contractions while simultaneously softening and dilating the cervix. 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Induced","enrollment":1308},{"nctId":"NCT01026948","phase":"","title":"Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM)","status":"COMPLETED","sponsor":"Liverpool Women's NHS Foundation Trust","startDate":"2009-01","conditions":"Intrapartum Fetal Monitoring, Pregnancy","enrollment":70},{"nctId":"NCT01170819","phase":"PHASE4","title":"Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.","status":"COMPLETED","sponsor":"Università degli Studi dell'Insubria","startDate":"2010-06","conditions":"Cervical Ripening, Labor Induction","enrollment":210},{"nctId":"NCT01099280","phase":"PHASE3","title":"Induction of Labor in Term Premature Rupture of Membranes: A Comparison Between Oxytocin and Dinoprostone Followed Six Hours Later by Oxytocin","status":"COMPLETED","sponsor":"Erzincan Military Hospital","startDate":"2009-11","conditions":"Labor, Induction, PROM (Pregnancy)","enrollment":225}],"_emaApprovals":[],"_faersSignals":[{"count":15,"reaction":"DRUG EXPOSURE DURING PREGNANCY"},{"count":14,"reaction":"CAESAREAN SECTION"},{"count":12,"reaction":"MATERNAL DRUGS AFFECTING FOETUS"},{"count":7,"reaction":"UTERINE HYPERTONUS"},{"count":6,"reaction":"INTRA-UTERINE DEATH"},{"count":6,"reaction":"PREMATURE SEPARATION OF PLACENTA"},{"count":5,"reaction":"APGAR SCORE LOW"},{"count":4,"reaction":"ANAPHYLACTOID SYNDROME OF PREGNANCY"},{"count":4,"reaction":"PRECIPITATE LABOUR"},{"count":3,"reaction":"BRADYCARDIA FOETAL"}],"_approvalHistory":[],"publicationCount":110,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Propess"],"phase":"marketed","status":"active","brandName":"Dinoprostone vaginal insert","genericName":"Dinoprostone vaginal insert","companyName":"HaEmek Medical Center, Israel","companyId":"haemek-medical-center-israel","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Dinoprostone is a prostaglandin E2 analog that binds to prostaglandin receptors to stimulate uterine contractions and promote cervical ripening and labor induction. Used for Cervical ripening and labor induction in pregnant women at or near term.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}