PREPIDIL SUMMARY
Prepidil® Gel
dinoprostone cervical gel
PREPIDIL Gel contains dinoprostone as the naturally occurring form of prostaglandin E2 (PGE2) and is designated chemically as (5Z, 11a, 13E, 15S)-11,15-Dihydroxy-9-oxo-prosta-5,13-dien-1-oic acid.
PREPIDIL Gel is indicated for ripening an unfavorable cervix in pregnant women at or near term with a medical or obstetrical need for labor induction.
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NEWS HIGHLIGHTS
Published Studies Related to Prepidil (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.
[Comparing two Prepidil gel regimens for cervical ripening before induction of labor at term: a randomized trial] [2009.06]
OBJECTIVES: To compare efficacy and safety of two regimens of intracervical dinoprostone (Prepidil) in cervical ripening before labor induction at term... CONCLUSIONS: Repeated intracervical doses of Prepidil every 6 hours, in cervical ripening before labor induction at term, enables higher delivery rate in the first 24 hours without inducing excess of caesarean sections or maternofetal morbidity when compared to its administration every 12 hours.
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.
Clinical Trials Related to Prepidil (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.
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
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