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Dinoprostone Vaginal (Dinoprostone Vaginal Insert) - Summary

 
 



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.

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Clinical Trials Related to Dinoprostone Vaginal

Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert for Reducing Time to Vaginal Delivery [Not yet recruiting]
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 micgrogram (mcg) can decrease time to vaginal delivery compared to dinoprostone vaginal insert 10 milligram (mg) in pregnant women who need cervical ripening and induction of labor.

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.

Comparison Between 25 �g Vaginal Misoprostol Versus Slow Release Pessary PGE2: a French Multicentre Randomised Controlled Trial [Recruiting]
For about 10% of pregnancies, it is necessary to induce delivery for medical reasons. Prostaglandins alone can be used to perform cervical ripening in cases of immature cervix. In France, dinoprostone is the own approved medication . It is in the form of gel or sustained release device whose effectiveness and side effects are comparable. The vaginal misoprostol has no marketing authorization in France, but is sometimes used. Some data in the scientific literature have showed that its use with low-dose (25 mcg) vaginally did not lead to more complications, was at least as effective and seems to be cost-effective compared with dinoprostone. Misoprostol with this dose and route of administration is now recommended by the American College of Obstetricians and Gynecologist (ACOG), Grade A (ACOG Practice Bulletin August 2009). This is not the case in France (French HAS 2008 Guidelines on induction of labor). According to HAS, the investigators still lack data on large samples to confirm the benefits of misoprostol 25 mcg vaginally, in terms of efficiency, rate of cesarean section, and lower cost compared to dinoprostone.

Feasibility and Acceptability of the Combination of Propess and AN24 Monica for Outpatient Labour Induction (PRAM) [Recruiting]
In order to confirm the feasibility of home monitoring with Monica AN 24, a licensed portable device for measuring fetal and maternal electrocardiogram (ECG), and the feasibility of inpatient monitoring with Monica AN 24 in patients with Propess a vaginal licensed drug delivery system used for induction of labour, we will perform a pilot study that will include 20 women in each arm.

Feasibility of monitoring with Monica AN 24 both in hospital and at home will be confirmed in a pilot study. The success will be defined as at least 10 minutes of continuous satisfactory trace in any given hour in at least 80% of the patient.

A main study will then be conducted to assess the feasibility and acceptability of the PRAM (Propess and Monica) package of care for women undergoing induction of labour.

The research questions are:

1. Is outpatient induction with continuous monitoring technically feasible?

2. Does the PRAM package of care provide adequate clinical information in line with the UK NICE Guideline for Induction of labour?

3. Is outpatient induction a concept that appeals to women?

4. What do women consider to be the advantages and disadvantages of this package of care?

5. What would women consider to be positive and/or negative outcome in future clinical trials of outpatient induction?

6. Do fetuses with abnormal ECG patterns have evidence of subclinically impaired cardiac function (feasibility study)?

7. Do elevated concentrations of white blood cell components in the umbilical cord blood at birth influence fetal ECG (feasibility study)?

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.

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Page last updated: 2011-12-09

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