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Misoprostol Vaginal Insert and Time to Vaginal Delivery: An

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Jack Jackson

on 6 September 2013

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Transcript of Misoprostol Vaginal Insert and Time to Vaginal Delivery: An

Misoprostol
Vaginal Insert and Time to
Vaginal Delivery: A RCT

-1:4 pregnancies in US are induced.
(3)

-When IOL is indicated, and the cervix is unfavorable, there are a number of options for cervical ripening including
mechanical
, and
pharmacological
.

-When the Bishop's Score is low enough (usually determined as a score <6)
prostaglandins
may be considered.
August 2013
Green Journal
Wing et al.
PGE1
Misoprostol
(25mcg pill)

PGE2
Dinoprostone
(10mg insert)

-
Double blind
, 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

Goals:
1) Brief overview of induction protocol
2) Brief understanding of protocol
3) Review of article
4) Thoughts moving forward
Balloon
ACOG 2009 guidelines:
-Effective for induction w/ unfavorable cervix

-Decreased CS rate compared to oxytocin alone
(1)

-Low cost, stable at room temp,
reduced risk of tachysystole

-Similar induction time as
Cervidil
(1)
PGE1
ACOG:
-Several RCT's and two metanalysis show efficacy in inducing labor
(2)

-As effective
or
superior
to PGE2

-Less epidurals, works FASTER than oxy/PGE2, but
more UTS and FHR decels
(1)

-Contraindicated in prior C/S Pt's or those w/ major uterine surgery Hx. Also in low AFI and IUGR.

-
CHEAP
. $0.26 per dose (25mcg)
(1)

-Not approved for cervical ripening by FDA

-
Stable
at room temp
PGE2
ACOG:
-Reduces time to delivery compared to oxytocin/placebo

-
Uterine tachysystole w/ FHT abnormalities
in ~5%, less common than with PGE1.
(1)

-Similar efficacy to PGE1

-
Expensive
. $218.94 per insert (1,000X cost)
(1)

-Can be removed
if needed

-Approved for cervical ripening by FDA

-
Unstable
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:
1)
Misoprostol (PGE1 analogue)
2)
Dinoprostone (PGE2) (
"Cervidil"
)

-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.

-
Both
have been shown to be
efficacious
in decreasing time to delivery,
both
can cause
UTS
.



PGE1
Misoprostol
(X mcg insert)


Background

-Endpoints:
1)
Time
to vaginal delivery
(efficacy)
2) Rate of
C-section
(safety)

-Secondary Endpoints:
1) Time to
any
delivery mode
2) Time to onset of
active labor
3)
Oxytocin
use

Methods
Methods cont.
PGE1
group (n=678)

To Deliver:
21.5 hrs
*

C/S: 26%

Any Delivery:
18.3 hrs
*

Active Labor onset:
12.1 hrs
*

Women requiring
oxytocin:
48.1%
*
Results
PGE2
group (n=680)

To Deliver:
32.8 hrs

C/S: 27.1%

Any Delivery:
27.3 hrs

Active Labor Onset:
18.6 hrs

Women requiring
oxytocin:
74.1%
MMC
Protocol
Cervical ripening
candidate
≤ Moderate IUGR
or oligo
Severe IUGR
or oligo
No Hx C/S
No uterine
surg
Chorioamnionitis?
Yes
No
Balloon
Cervidil
Miso
Table 1
Table 2
Adverse Events --> CS
Of those who went on to C/S...
Uterine tachysystole w/CIII tracing occured in
13
(2%) vs.
0

Arrest of dilation occured in
8.6%
vs.
12.5%

Adverse Events (in general)
PGE1

~3X risk of
UTS
~3X increased
tocolysis
use
~1.3 X risk meconium in amniotic fluid
PGE2

~1.3X risk of
arrested labor
~1.5X risk of
Chorioamnionitis
and
ABx
~1.8X risk of postpartum ABx
Discussion
Why is this important?
Prolonged labor
-->
-More infections
-Greater maternal distress
-More oxytocin
-More hospital/staff resources
-Lower maternal satisfaction
Limitations
1) UTS remains a risk with the PGE1 insert; but it was a
large

dose
, the insert would be
removable
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.
Take away:
Misoprostol vaginal insert
reduced the median time to vaginal delivery by

~11 hours

compared to
PGE2
vaginal insert, with similar adverse events as the
PGE1
pill, and has the benefit of being REMOVABLE
Going Forward
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
Full transcript