Cervidil (Dinoprostone Vaginal) - Summary

CERVIDIL SUMMARY

CERVIDIL^®
Brand of dinoprostone vaginal insert

Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.

Cervidil Vaginal Insert (dinoprostone, 10 mg) is indicated for the initiation and/or continuation of cervical ripening in patients at or near term in whom there is a medical or obstetrical indication for the induction of labor.

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NEWS HIGHLIGHTS

Published Studies Related to Cervidil (Dinoprostone Vaginal)

Factors predicting successful labor induction with dinoprostone and misoprostol vaginal inserts. [2009.08]
OBJECTIVE: To evaluate the maternal and pregnancy characteristics that independently predict successful induction of labor, defined as vaginal delivery... CONCLUSION: Maternal characteristics such as BMI, parity, age, and race and neonatal birth weight are important variables to consider when predicting a successful induction of labor. The nearly 30% rate of cesarean delivery in this study underscores the importance of selecting appropriate candidates. LEVEL OF EVIDENCE: II.

Comparative efficacy and safety of vaginal misoprostol versus dinoprostone vaginal insert in labor induction at term: a randomized trial. [2009.07]
OBJECTIVE: To compare efficacy and safety of vaginal misoprostol (PGE(1) analog) with dinoprostone (PGE(2) analog) vaginal insert for labor induction in term pregnancies... CONCLUSION: Using vaginal misoprostol is an effective way of labor induction in term pregnant women with unfavorable cervices, since it is associated with a shorter duration of labor induction and higher rates of vaginal delivery within 12 h. Misoprostol and dinoprostone are equally safe, since misoprostol did not result in a rise in maternal and neonatal morbidity, namely, tachysystole, uterine hyperstimulation, cesarean section rates and admission to neonatal intensive care units as reported previously in literature.

Concurrent dinoprostone and oxytocin for labor induction in term premature rupture of membranes: a randomized controlled trial. [2009.05]
OBJECTIVE:: To estimate the effect of concurrent vaginal dinoprostone and oxytocin infusion against oxytocin infusion for labor induction in premature rupture of membranes (PROM) on vaginal delivery within 12 hours and patient satisfaction... CONCLUSION:: Concurrent vaginal dinoprostone and intravenous oxytocin for labor induction of term PROM did not expedite delivery or improve patient satisfaction. CLINICAL TRIAL REGISTRATION:: Current Controlled Trials, www.controlled-trials.com, ISRCTN74376345 LEVEL OF EVIDENCE:: I.

Misoprostol vaginal insert compared with dinoprostone vaginal insert: a randomized controlled trial. [2008.10]
OBJECTIVE: To compare the 50-microgram (misoprostol vaginal insert 50) and 100-microgram (misoprostol vaginal insert 100) dose reservoirs of the misoprostol vaginal insert to 10-mg dinoprostone vaginal insert for time to vaginal delivery and rate of cesarean delivery... CONCLUSION: The misoprostol vaginal insert 100 and the dinoprostone vaginal insert had similar median time intervals to vaginal delivery, whereas the misoprostol vaginal insert 50 had a significantly longer time to vaginal delivery. The three products had similar cesarean rates and safety profiles.

Induction of labour in nulliparous and multiparous women: a UK, multicentre, open-label study of intravaginal misoprostol in comparison with dinoprostone. [2008.09]
OBJECTIVE: To compare the efficacy and safety of a 25-microgram vaginal tablet of misoprostol (APL202) with dinoprostone (3-mg vaginal tablet) in cervical ripening and labour induction. DESIGN: A randomised, open-label, noninferiority, comparative study in two maternal populations. SETTING: Eighteen NHS study centres across the UK. POPULATION: Nulliparous or multiparous women with a singleton pregnancy eligible for induction of labour... CONCLUSIONS: Low-dose misoprostol is efficacious in cervical ripening and labour induction and demonstrates a similar fetal and maternal safety profile to dinoprostone.

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Clinical Trials Related to Cervidil (Dinoprostone Vaginal)

Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor [Completed]
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 their labor induced.

Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess [Completed]
The aim of this study is to compare two different preparation

Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term [Recruiting]
The purpose of this study is to determine whether induction of labor with vaginal misoprostol application will result in fewer cesarean deliveries than vaginal PGE2 gel application in women with premature rupture of membranes at term.

Reduced Intensity, Sequential Double Umbilical Cord Blood Transplantation Using Prostaglandin E2 (PGE2) [Recruiting]
The purpose of this research study is to determine the effects of 16, 16 Dimethyl-Prostaglandin E2 (dmPGE2) treatment on umbilical cord blood units to be used in transplantation. dmPGE2 treatment is being tested to see if it can improve the ability of umbilical cord blood stem cells to grow after transplantation. The growth of stem cells after transplantation is sometimes referred to as "engraftment". One of the major problems after umbilical cord transplantation is the time required for engraftment. After transplantation of two umbilical cord blood units, the average time to achieve engraftment is 21 days. In addition, up to 10% of patients who undergo umbilical cord blood transplantation never engraft, a potentially life-threatening condition. In laboratory studies, treatment of umbilical cord blood stem cells with dmPGE2 was shown to enhance engraftment.

Headache Inducing Characteristics and Possible Changes in Cerebral Blood Flow After Administration of PGE2 [Completed]
Before, during and after intravenous administration of PGE2 we score/measure headache, rCBF, blood flow in the middle cerebral artery and diameter of superficial temporal artery and correlate that to known pathophysiology of headache to see if PGE2 is involved in headache pathophysiology.

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