SUMMARY
Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of a knitted polyester retrieval system, an integral part of which is a long tape. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone. The hydrogel insert is contained within the pouch of an off-white knitted polyester retrieval system designed to aid retrieval at the end of the dosing interval. 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 Dinoprostone Vaginal
A randomized clinical trial to compare the efficacy of different doses of intravaginal misoprostol with intracervical dinoprostone for cervical ripening and labor induction. [2011.07] OBJECTIVES: To compare the efficacy of 25 vs. 50 microg of intravaginal misoprostol vs. intracervical dinoprostone for cervical ripening and labor induction... CONCLUSION: Intravaginal misoprostol 50 microg administered 6 hourly appears to be most effective as it has least induction to delivery time, has maximum improvement in Bishop's score, least oxytocin requirement without any increase in complication rate.
Cardiotocographic abnormalities associated with misoprostol and dinoprostone cervical ripening and labor induction. [2011.06] OBJECTIVE: To characterize the incidence and timing of cardiotocographic (CTG) abnormalities associated with misoprostol and dinoprostone vaginal inserts during labor induction... CONCLUSION: Cardiotocographic abnormalities were less frequent and occurred after longer exposure with MVI 50 than MVI 100 or dinoprostone. Clinical outcomes were similar among the groups. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.
[Comparison of isosorbide dinitrate and dinoprostone for induction of labor in term pregnancy]. [2011.05] CONCLUSIONS: the isosorbide dinitrate is associated with lower duration of labor compared with dinoprostone. There was no difference in the maternal-fetal outcome by using whatever drug.
Induction of labor and pain: a randomized trial between two vaginal preparations of dinoprostone in nulliparous women with an unfavorable cervix. [2011.05] OBJECTIVE: To compare pain associated with vaginal dinoprostone pessary vs. gel for induction of labor in women with an unfavorable cervix... CONCLUSIONS: The two induction procedures should be considered equivalent as far as ripening the cervix and initiating labor. In view of this finding, the low Bishop score should be considered an indication to prefer the controlled-release device, since it reduces pain thereby improving the physical and emotional wellbeing of the parturient.
Sustained-release dinoprostone vaginal pessary with concurrent high-dose oxytocin infusion compared to sustained-release dinoprostone vaginal pessary followed 6 h later by high-dose oxytocin infusion for labor induction in women at term with unfavorable cervix: a randomized controlled trial. [2011] OBJECTIVE: To compare the efficacy and safety of sustained-release dinoprostone vaginal pessary and concurrent high-dose oxytocin infusion with sustained-release dinoprostone vaginal pessary followed 6 h later by high-dose oxytocin infusion for cervical ripening and labor induction... CONCLUSION: Sustained-release dinoprostone followed 6 h later by high-dose oxytocin infusion appears to be safer and more effective than sustained-release dinoprostone with concurrent high-dose oxytocin infusion in achieving cervical ripening and successful vaginal delivery. Copyright (c) 2010 S. Karger AG, Basel.
Clinical Trials Related to Dinoprostone Vaginal
Comparison of Misoprostol and Prostaglandin E2 (PGE2) Gel for Induction of Labour in Premature Rupture of Membranes at Term [Completed]
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.
Labour Induction With Misoprostol, Dinoprostone and Bard Catheter [Completed]
This is a randomised study aimed at comparing the currently most frequently used
prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective
prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and
randomised to one of the three methods. The main outcome measures were time to delivery,
rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that
misoprostol would be superior to the other methods.
The main finding of our trial was that the catheter showed the shortest induction to
delivery interval. There were no differences between the two other prostaglandins. No
differences in maternal and neonatal outcome was found
Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery [Completed]
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200
microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone
Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and
induction of labor.
Titrated Oral Misoprostol Compared to Vaginal Dinoprostone for Induction of Labor [Recruiting]
Oral Misoprostol Versus Vaginal Dinoprostone For Induction Of Labour: A Randomized Controlled Clinical Trial [Recruiting]
This study is to compare between oral misoprostol in solution and vaginal dinoprostone in
induction of labour in primiparous women with singleton pregnancy as regards efficiency and
safety to both mother and fetus.
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