Mifepristone for Unintended or Failed Pregnancy Wesley Medical Center Department of Obstetrics and Gynecology May 29, 2019 Alhambra Frarey, MD, MSHP, FACOG Assistant Professor of Obstetrics and Gynecology University of Pennsylvania Division of Family Planning
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Mifepristone for Unintended or
Failed Pregnancy
Wesley Medical Center
Department of Obstetrics and Gynecology
May 29, 2019
Alhambra Frarey, MD, MSHP, FACOG
Assistant Professor of Obstetrics and Gynecology
University of Pennsylvania
Division of Family Planning
2
Disclosures
I have nothing to disclose
I will be discussing evidenced-based, off-
label use of medications
3
Goals
Landscape of abortion and pregnancy loss
History of mifepristone in the US
Medical management of first and second
trimester abortion and pregnancy loss
4
Outline
Background and history of medical abortion
First trimester medical abortion
Medical management of early pregnancy
loss
Medical management of second trimester
abortion and pregnancy loss
5
Background: Pregnancy outcomes in 2008
2.3 million
women
experienced
pregnancy loss
or abortion in
the U.S. in
2008
6
Abortion in the US
Nearly half of pregnancies are unplanned
1 in 4 women will have an abortion
926,200 abortions performed in 2014
Jones et al. Perspect Sex Repro Health, 2014
10
Who Has Abortions?
11
WHEN WOMEN HAVE PREGNANCY LOSS
80% of pregnancy
losses occur in
the first 12 weeks
of pregnancy
Background: when women have abortions
12
Top Three Reasons for Abortion
Responsibility to other individuals
Inability to afford a child
Interference with work, school or other
responsibility
Finer, 2005
13
Safety of Abortion
One of the safest medical procedures
No risk to future reproduction
No risk of breast cancer
No increased risk of depression
The strongest risk factor for abortion related
mortality is gestational age
Weitz et al. Am Journal of Pub Health, 2013
Bartlet et al. Obstet Gynecol, 2004.
Earlier Is Safer
14
Medical vs procedural management
Jones RK and Jerman J, PSRH, 2017; Schreiber et al, NEJM 2018
Up to 40% of women offered medical and surgical
management of miscarriage will choose medical
management
31%
69%
45%
55%
15
Medical vs Surgical
Characteristics of Early Abortion Methods
Aspiration Abortion Medical Abortion
Highly effective Highly effective
Procedure brief Process takes one to several days to
*All successes by day 3 were with 1 dose and no additional interventions (primary outcome for the trial). **All p-values are ≤ .001Data are presented as n (%).
Women receiving combined treatment are
63% less likely to need a procedure(NNT=7)
45
Serious Adverse Events
Total
(n=300)
Miso Alone
(n=151)
Combined
(n=149)
p-value
Transfusion 4 (1%) 1 (<1%) 3 (2%) 0.31
Infection 4 (1%) 2 (1%) 2 (1%) 0.99
Interim Visit 45 (15%) 26 (17%) 19 (13%) 0.28
Data are presented as n (%)
46
Conclusions
Combined treatment improves rapid success by
25%
Combined treatment avoids one procedure for
every 7 women treated
Safety is not compromised
Combined regimen should be standard of care
47Practice Bulletin No. 200. Obstet Gynecol Aug 2018
48
REMS Criteria
Prohibits prescription through pharmacy
Providers must complete provider
agreement form
Complete Danco patient agreement form
Provide medication guide to patient
Second Trimester Abortion and
Pregnancy Loss
52
Mifepristone for IOL
Day 1 Day 2
Buccal misoprostol
400mcgIf placenta in but
fetus out, one more
dose of miso and
wait 6 hr before
D&E
Ngoc, et al. Obstet Gynecol, 2011
14-21 weeks, live fetus
Q 3 h up to 5 doses
If no fetal expulsion
3 hr after last dose,
D&E
53
Mifepristone for IOL
Ngoc NTN, et al. Obstet Gynecol, 2011
54
Mifepristone for IOL
RCT
Median induction time 8.6 h vs. 18.2 h
No difference in side effects
Dabash, et al. Int J Gyn Obst, 2015
55
Mifepristone for IOL
Elami-Suzin M, et al. Obst Gyn, 2013
14-24 weeks, live or demised fetus
Time 0 36 hrExpulsion of fetus
after 36 hr
Vaginal misoprostol
800mcg
+ 400mcg PO q 3 x 4
High-dose pitocin
(150 mU/min)
56
Mifepristone for IOL
Elami-Suzin M, et al. Obst Gyn, 2013
57
Mifepristone in second-trimester pregnancy loss
Mife+miso
N=53
Placebo+miso
N=52
P
Successful
delivery
49 (92.5%) 37 (71.2%) 0.001
Mean induction
time (h)
9.8 ± 4.4 16.3 ± 5.7 <0.001
Randomized, placebo-controlled trial in India
IUFD of GA 20 weeks or greater
Mifepristone 200 mg, 100 mcg misoprostol vaginally
every 6 hours
Chaudhuri et al, J Obstet Gynecol Res, 2015
Data for previable PPROM is scant: but minimal
harm in adding mifepristone to induction regimen
58
Dosing interval
Induction time vs. total procedure time
59
Dosing interval
Shaw, et al. Obst Gyn, 2013
Induction Time Total Procedure Time
60
Dosing interval
RCT, n = 509
Mifepristone 24 h before vs. at the time of first miso
dose
24 h before Simultaneous
Complete abortion
at 24 h94.4% 85.0%*
Complete abortion
at 48 h96.8% 95.7%
Median induction
time7.7 h 13.0 h*
Median total
procedure time32.3 h 13.0 h*
Abbas, et al. Obst Gyn, 2016
* Statistically significant difference
61
Simultaneous Mife and Miso
Prospective study of 150 patients
Mife 200 mg + Miso 400 mcg → Miso 200 mcg every
4 hours
End point was expulsion of placenta
Mean induction time 13 hours
96% complete by 24%
100% by 32 hours
Shripad Jahagirdar, Int J Reprod Contra Obst Gyn, 2015
62
Guidelines
Preferred regimen
(efficacy, speed, side effects)
• Mifepristone 200mg PO
• 24-48 hr interval
• Misoprostol 800mcg vaginally
• Misoprostol 400mcg vaginally or sublingually q 3 hr
• Max 5 doses
• If not complete, rest 12 hr and restart
ACOG Practice Bulletin No 135, 2013
63
Guidelines
Combined is ideal
• Mifepristone 200mg
• 24-48 hr interval
• Misoprostol loading dose 600-800mcg vaginally
• Misoprostol 200mcg q 3 h (vaginal or sublingual)
Pregnancies with a fetal demise may be treated
similarly; may need lower doses and have a shorter