{"id":"administration-of-propess","safety":{"commonSideEffects":[{"rate":"5-10","effect":"Uterine hyperstimulation with fetal heart rate changes"},{"rate":"5-15","effect":"Vaginal pain or irritation"},{"rate":"5-10","effect":"Fever"},{"rate":"5","effect":"Nausea"},{"rate":"3-5","effect":"Diarrhea"},{"rate":"3-5","effect":"Back pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Propess contains dinoprostone, a naturally occurring prostaglandin E2 analog, which is released gradually from a polymer matrix insert placed in the vaginal fornix. The prostaglandin acts on cervical tissue to promote softening, effacement, and dilation of the cervix, facilitating the onset of labor. This localized delivery system provides sustained release over 12-24 hours, reducing systemic exposure compared to intravenous administration.","oneSentence":"Propess is a vaginal insert that delivers dinoprostone (prostaglandin E2) directly to the cervix to promote cervical ripening and labor induction.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:00:02.050Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cervical ripening and labor induction in pregnant women at or near term with medical or obstetric indication for labor induction"}]},"trialDetails":[{"nctId":"NCT07366359","phase":"NA","title":"PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)","status":"RECRUITING","sponsor":"National Hospital of Obstetrics and Gynecology","startDate":"2026-02-10","conditions":"Premature Rupture of Fetal Membranes, Labor, Induced, Cervical Ripening","enrollment":450},{"nctId":"NCT06803992","phase":"PHASE4","title":"Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter","status":"RECRUITING","sponsor":"HaEmek Medical Center, Israel","startDate":"2025-04-06","conditions":"Induction of Labor","enrollment":140},{"nctId":"NCT02888041","phase":"PHASE3","title":"Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?","status":"TERMINATED","sponsor":"University Hospital, Limoges","startDate":"2016-12","conditions":"Cervical Ripening, Pregnancy","enrollment":160},{"nctId":"NCT04773314","phase":"","title":"General Drug Use-results Survey on PROPESS Vaginal Inserts in Treatment for Initiation of Cervical Ripening in Patients at Term (From 37 Completed Weeks of Gestation)","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2021-02-28","conditions":"Cervical Ripening, Pregnancy","enrollment":409},{"nctId":"NCT05430711","phase":"PHASE4","title":"Dinoprostone Induction vs. Expectant Management After PROM at Term","status":"UNKNOWN","sponsor":"University Medical Centre Ljubljana","startDate":"2022-06","conditions":"Prelabor Rupture of Membranes","enrollment":70},{"nctId":"NCT01720394","phase":"PHASE4","title":"Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert","status":"UNKNOWN","sponsor":"Medical University of Graz","startDate":"2013-11","conditions":"Cervical Ripening, Induction of Labor","enrollment":253},{"nctId":"NCT01765881","phase":"PHASE2","title":"Comparison Between 25 µg Vaginal Misoprostol vs Slow Release Pessary PGE2","status":"COMPLETED","sponsor":"University Hospital, Toulouse","startDate":"2012-09","conditions":"Delivery Uterine","enrollment":1700},{"nctId":"NCT02684305","phase":"PHASE3","title":"Stepwise Labor Induction Following Failure of Prostaglandin Vaginal Insert for Labor Induction","status":"UNKNOWN","sponsor":"Tel-Aviv Sourasky Medical Center","startDate":"2016-04","conditions":"Induction of Labor","enrollment":320}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":51,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Administration of Propess","genericName":"Administration of Propess","companyName":"Tel-Aviv Sourasky Medical Center","companyId":"tel-aviv-sourasky-medical-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Propess is a vaginal insert that delivers dinoprostone (prostaglandin E2) directly to the cervix to promote cervical ripening and labor induction. Used for Cervical ripening and labor induction in pregnant women at or near term with medical or obstetric indication for labor induction.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}