Published Studies Related to Prepidil (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. 
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 Prepidil (Dinoprostone Vaginal)
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)?
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
Comparison of Pre-Induction Cervical Ripening [Recruiting]
This study is designed to assess the effectiveness of a combination method of induction of
labor using a urinary balloon catheter and prostaglandin gel.
The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery
rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed
induction in the United States is rising. This has led to a renewed effort to examine the
effectiveness of the varied methods of induction.
The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel
for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto
Health Richland for a scheduled induction of labor will be offered enrollment in the trial.
Patients who enroll in the study will be randomized into one of 3 study arms: urinary
balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and
prostaglandin gel. Randomization will be per sealed envelope from the locked nurse
medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland.
The investigator will be given the next sequentially numbered study randomization envelope
by the patient's nurse. The randomization assignment will be unblinded to the patient and
her physicians. If the patient is not in active labor 6 hours after initiation of the
intervention, a standardized protocol of oxytocin will commence. Labor management will be at
the discretion of the physician.
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
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.