{"id":"propess-dinoprostone","safety":{"commonSideEffects":[{"rate":null,"effect":"Uterine hyperstimulation"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Nausea and vomiting"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Abdominal pain"},{"rate":null,"effect":"Vaginal pain or irritation"}]},"_chembl":{"chemblId":"CHEMBL548","moleculeType":"Small molecule","molecularWeight":"352.47"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Dinoprostone binds to prostaglandin F (FP) receptors on uterine smooth muscle, increasing intracellular calcium and triggering myometrial contractions. It also promotes cervical softening and dilation by increasing collagenase activity and promoting cervical remodeling, facilitating labor induction or augmentation.","oneSentence":"Dinoprostone is a prostaglandin F2α analog that stimulates uterine contractions and cervical ripening to induce labor.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:02:53.732Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Labor induction in pregnant women at or near term"},{"name":"Cervical ripening prior to labor induction"}]},"trialDetails":[{"nctId":"NCT02907060","phase":"PHASE3","title":"Mechanical cervicAl ripeninG for Women With PrOlongedPregnancies","status":"COMPLETED","sponsor":"University Hospital, Tours","startDate":"2017-01-27","conditions":"Prolonged Pregnancy","enrollment":1224},{"nctId":"NCT04949633","phase":"PHASE3","title":"Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening","status":"RECRUITING","sponsor":"University Hospital, Tours","startDate":"2021-09-28","conditions":"Cervical Ripening, Unfavorable Cervix","enrollment":1494},{"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":"NCT04747301","phase":"NA","title":"DOuble-BAlloon Versus PROstaglandin E2 for Cervical Ripening in Low Risk Pregnancies","status":"UNKNOWN","sponsor":"Hanoi Obstetrics and Gynecology Hospital","startDate":"2021-08-01","conditions":"Induction of Labor","enrollment":540},{"nctId":"NCT04452747","phase":"NA","title":"Artificial Induction of Labour in Full-term Singleton Pregnancy : Comparative Randomized Trial of Two Strategies","status":"COMPLETED","sponsor":"University Hospital, Montpellier","startDate":"2020-11-16","conditions":"Pregnancy Related","enrollment":450},{"nctId":"NCT04955847","phase":"","title":"Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term","status":"UNKNOWN","sponsor":"Centre Hospitalier Universitaire, Amiens","startDate":"2021-07-05","conditions":"Induction of Labor, Vaginal Delivery, Cesarean Section","enrollment":700},{"nctId":"NCT02956785","phase":"PHASE2","title":"What After the First Propess","status":"TERMINATED","sponsor":"South Warwickshire NHS Foundation Trust","startDate":"2017-01","conditions":"Induction of Labor","enrollment":85},{"nctId":"NCT03001661","phase":"PHASE3","title":"An RCT of a Synthetic Osmotic Cervical Dilator for Induction of Labour in Comparison to Dinoprostone Vaginal insErt","status":"COMPLETED","sponsor":"Birmingham Women's NHS Foundation Trust","startDate":"2017-12-19","conditions":"Induction of Labor Affected Fetus / Newborn","enrollment":674},{"nctId":"NCT03067597","phase":"PHASE3","title":"An Open-label Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2017-02-22","conditions":"Cervical Ripening","enrollment":68},{"nctId":"NCT03067727","phase":"PHASE3","title":"A Randomised Trial Investigating the Efficacy and Safety of a Vaginal Insert in Pregnant Women at Term","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2017-04-03","conditions":"Cervical Ripening","enrollment":114},{"nctId":"NCT03310333","phase":"PHASE4","title":"Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes","status":"UNKNOWN","sponsor":"University Hospital, Clermont-Ferrand","startDate":"2018-02-14","conditions":"PROM (Premature Rupture Of Foetal Membrane)","enrollment":80},{"nctId":"NCT02861079","phase":"PHASE2","title":"Combined Foley Catheter Balloon and PGE2 Vaginal Ovule for Induction of Labor at Term: A Randomized Study","status":"COMPLETED","sponsor":"Zeynep Kamil Maternity and Pediatric Research and Training Hospital","startDate":"2017-08-25","conditions":"Unfavorable Cervix, Cervical Ripening","enrollment":300},{"nctId":"NCT03050684","phase":"NA","title":"Does Vaginal Washing Affect the Success Rate of the Labour Induction?","status":"COMPLETED","sponsor":"Zeynep Kamil Maternity and Pediatric Research and Training Hospital","startDate":"2017-02-20","conditions":"Labor Induction, Dinoprostone Vaginal Insert, Vaginal Infection","enrollment":200},{"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}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":56,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Propess® (dinoprostone)","genericName":"Propess® (dinoprostone)","companyName":"University Hospital, Clermont-Ferrand","companyId":"university-hospital-clermont-ferrand","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Propess (dinoprostone) is a small molecule that acts as a prostaglandin E2 receptor agonist. It is used for cervical ripening and labor induction, typically administered via a controlled-release vaginal insert.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}