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Prostin E2 (Dinoprostone Vaginal) - Summary

 



BOX WARNING

WARNINGS

Dinoprostone, as with other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Dinoprostone should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

 

PROSTIN E2 SUMMARY

Prostin E2®
dinoprostone vaginal
suppository

PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2).

  1. PROSTIN E2 Vaginal Suppository is indicated for the termination of pregnancy from the 12th through the 20th gestational week as calculated from the first day of the last normal menstrual period.
  2. PROSTIN E2 is also indicated for evacuation of the uterine contents in the management of missed abortion or intrauterine fetal death up to 28 weeks of gestational age as calculated from the first day of the last normal menstrual period.
  3. PROSTIN E2 is indicated in the management of nonmetastatic gestational trophoblastic disease (benign hydatidiform mole).

See all indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Prostin E2 (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.

more studies >>

Clinical Trials Related to Prostin E2 (Dinoprostone Vaginal)

Combined Agent Randomized Trial of Induction of Labor [Completed]
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.

Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study) [Completed]
Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.

Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies [Not yet recruiting]

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

more trials >>

Page last updated: 2009-10-20

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