CLINICAL TRIALS PROFILE FOR CERVIDIL
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All Clinical Trials for Cervidil
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00140114 ↗ | Sublingual Versus Vaginal Misoprostol for Labor Induction at Term | Completed | American University of Beirut Medical Center | Phase 3 | 2004-01-01 | Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. In contradistinction to prostaglandin E2 preparations (dinoprostone, Prepidil, Cervidil), misoprostol is inexpensive and available in scored tablets that can be broken and inserted vaginally. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance as both a labor induction and a cervical ripening agent. Such off-label indication has been endorsed by the American College of Obstetricians and Gynecologists and other medical bodies. Recently, FDA approved a new label for the use of cytotec during pregnancy which removed pregnancy as a contraindication for its use. Vaginal administration seems to be more efficacious than when given orally, although there is the worry of uterine tachysystole and hyperstimulation with vaginal doses > 50-µg. The use of sublingual misoprostol for cervical ripening at term was recently investigated in two studies that compared it to the oral route, on the assumption that the sublingual route would have the higher efficacy of the vaginal route by avoiding the first pass effects of the gastrointestinal and hepatic systems, while having lower hyperstimulation rates by avoiding the direct effects on the cervix. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the induction of labor at term. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually. |
| NCT00308711 ↗ | Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor | Completed | Ferring Pharmaceuticals | Phase 3 | 2006-04-01 | The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor. |
| NCT00504465 ↗ | Combined Agent Randomized Trial of Induction of Labor | Completed | Weill Medical College of Cornell University | N/A | 2002-05-01 | To compare sequential dinoprostone and oxytocin for induction of labor at term with intact membranes and an unripe cervix to two simultaneous regimens. Our aim was to confirm findings from smaller trials and add to data on fetal safety. |
| NCT01402050 ↗ | Foley Catheter Versus Cervidil for Induction of Labor at Term | Completed | Mednax Center for Research, Education and Quality | N/A | 2010-06-01 | OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction. HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™). |
| NCT01402050 ↗ | Foley Catheter Versus Cervidil for Induction of Labor at Term | Completed | Mednax Center for Research, Education, Quality and Safety | N/A | 2010-06-01 | OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction. HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™). |
| NCT01962831 ↗ | Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter | Completed | Regina Qu'Appelle Health Region | N/A | 2013-10-01 | The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group. |
| NCT01962831 ↗ | Randomized Controlled Trial: Induction of Labour of Obese Women With Dinoprostone or Single Balloon Catheter | Completed | Saskatchewan Health Authority - Regina Area | N/A | 2013-10-01 | The purpose of this study is to compare the efficacy of single balloon foley catheters to dinoprostone for the induction of labour of obese women. The investigators suspect that women assigned to the foley group will have a shorter induction to delivery time than women in the dinoprostone group. |
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