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Misoprostol Vaginal Insert and Time to Vaginal Delivery: An
Transcript of Misoprostol Vaginal Insert and Time to Vaginal Delivery: An
Vaginal Insert and Time to
Vaginal Delivery: A RCT
-1:4 pregnancies in US are induced.
-When IOL is indicated, and the cervix is unfavorable, there are a number of options for cervical ripening including
-When the Bishop's Score is low enough (usually determined as a score <6)
may be considered.
Wing et al.
, phase III study
-Term women (>36 wks), parity ≤3, with a modified
Bishop score of ≤ 4
-678 women Miso gel infused mesh insert
-680 women Dino gel infused mesh insert
-Removed at active labor onset, or if
there was an adverse outcome,
24 hrs, or at maternal request
1) Brief overview of induction protocol
2) Brief understanding of protocol
3) Review of article
4) Thoughts moving forward
ACOG 2009 guidelines:
-Effective for induction w/ unfavorable cervix
-Decreased CS rate compared to oxytocin alone
-Low cost, stable at room temp,
reduced risk of tachysystole
-Similar induction time as
-Several RCT's and two metanalysis show efficacy in inducing labor
-Less epidurals, works FASTER than oxy/PGE2, but
more UTS and FHR decels
-Contraindicated in prior C/S Pt's or those w/ major uterine surgery Hx. Also in low AFI and IUGR.
. $0.26 per dose (25mcg)
-Not approved for cervical ripening by FDA
at room temp
-Reduces time to delivery compared to oxytocin/placebo
Uterine tachysystole w/ FHT abnormalities
in ~5%, less common than with PGE1.
-Similar efficacy to PGE1
. $218.94 per insert (1,000X cost)
-Can be removed
-Approved for cervical ripening by FDA
at room temp
(1) ACOG practice bulletin 107 (Aug. 2009)
(2) Dinoprostone Compared With Misoprostol for Cervical Ripening for Induction of Labor at Term.
Sara Church et al. MSDisclosures
J Midwifery Womens Health. 2009;54(5):405-411.
(3) Misoprostol Vaginal Insert and Time to Vaginal Delivery: A RCT. August 2013, Green Journal
Wing et al.
(4) Factors Predicting Successful Labor Induction With Dinoprostone and Misoprostol Vaginal Inserts
Pevzner et al. Obstetrics & Gynecology:
August 2009 - Volume 114 - Issue 2, Part 1 - pp 261-267
(5) Randomized controlled trial of vaginal misoprostol versus dinoprostone vaginal insert for labor induction
Garry et al. 2003, Vol. 13, No. 4 , Pages 254-259
(6) Misoprostol Vaginal Insert Compared With Dinoprostone Vaginal Insert: A Randomized Controlled Trial
Wing et al. Obstetrics & Gynecology: October 2008 - Volume 112 - Issue 4 - pp 801-812
-There are two prostaglandins that are commonly used:
Misoprostol (PGE1 analogue)
Dinoprostone (PGE2) (
-Misoprostol is cheap, but has greater risks and is delivered as pills that can't be "taken back".
-Dinoprostone is expensive, but has lower risks and is delivered as a removable insert.
have been shown to be
in decreasing time to delivery,
(X mcg insert)
to vaginal delivery
2) Rate of
1) Time to
2) Time to onset of
Active Labor onset:
Active Labor Onset:
≤ Moderate IUGR
No Hx C/S
Adverse Events --> CS
Of those who went on to C/S...
Uterine tachysystole w/CIII tracing occured in
Arrest of dilation occured in
Adverse Events (in general)
~3X risk of
~1.3 X risk meconium in amniotic fluid
~1.3X risk of
~1.5X risk of
~1.8X risk of postpartum ABx
Why is this important?
-Greater maternal distress
-More hospital/staff resources
-Lower maternal satisfaction
1) UTS remains a risk with the PGE1 insert; but it was a
, the insert would be
there is currently a trial testing other dose regimens (50, 100, 150, 200)
2) Power was too low to judge importance of some adverse outcomes such as fetal acidosis and low Apgars.
3) Inclusion criteria were relatively strict; Bishop's score of ≤4 and no fetal compromise at baseline for example
4) PGE2 insert was allowed to remain in place for 24 hrs, greater than the 12hrs it is recommended for.
Misoprostol vaginal insert
reduced the median time to vaginal delivery by
vaginal insert, with similar adverse events as the
pill, and has the benefit of being REMOVABLE
Wing et al. showed in 2008 that a 100ug PGE1 insert has the same median time to delivery as PGE2, with similar safety profiles
If this insert were available, it would allow the benefits of Miso with the user control to remove it if adverse reactions are witnessed
Hopefully, it would also have the advantage of costing LESS than cervidil
Ferring pharm. who manufactured the MVI has stated it was rejected in May of this year by the FDA, and declined to comment further on projected cost/availability