NEWS HIGHLIGHTS
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. [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 Prepidil (Dinoprostone Vaginal)
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.
Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert [Not yet recruiting]
The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter
for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not
greater than 6) compared to medical treatment using a dinoprostone
slow-release-vaginal-insert.
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)?
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.
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.
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