ACEP clinical policy:
complications of early pregnancy
sigrid hahn, MD MPH
mount sinai school of medicine, NY NY
disclosures
none
2012 update
applies to
stable patients
in the first trimester with
abdominal pain or vaginal
bleeding
does not apply to
patients with vital sign
instability,
infertility treatment (at high risk
for heterotopic pregnancy),
other presenting complaints
what is your
“rule out ectopic” algorithm?
27 y/o F G1P0 LMP 5 weeks ago
β hCG 1950 mIU/mL
no IUP seen on bedside pelvic US
a) repeat bedside US and attempt to
visualize adnexa
b) get a stat comprehensive US
c) get a comprehensive US ASAP
c) consult OB
d) d/c with 48 hour follow up
27 y/o F G1P0 LMP 5 weeks ago
β hCG 950 mIU/mL
no IUP seen on bedside pelvic US
a) repeat bedside US and attempt to
visualize adnexa
b) get a stat comprehensive US
c) get a comprehensive US ASAP
c) consult OB
d) d/c with 48 hour follow up
classic “rule out” ectopic algorithm
BhcG
β hCG >1500
β hCG <1500
mIU/mL
48 hour
f/u
US
IUP
Condous. BJOG. 112: 827-29. 2005
possible or
proven
ectopic
mIU/mL
classic algorithm grew out of the
concept of the
discriminatory zone
sensitivity of pelvic US for IUP
nears100%
β hCG 1000 - 2000 mIU/mL
IUP may be present but not yet
visible
classic algorithm is based on
several false assumptions
The beta and the discriminatory zone
should help guide your evaluation and
disposition
The beta and the discriminatory zone
should help guide your evaluation and
disposition
the very concept of the
discriminatory zone
has been challenged
positive LR 0.8 (95CI 0.5 to 1.4)
negative LR 1.1 (95CI 0.8 to 1.5)
Wang. Ann Emerg Med. 2011; 58:12-20
Wang. Ann Emerg Med. 2011; 58:12-20
IUPs that would be
misdiagnosed as
abnormal or ectopic
pregnancies
β hCG (mIU/mL)
patients with empty uterus on
comprehensive US and final
diagnosis of IUP
1000 - 1499
19
1500 -1999
12
> 2000
9
Doubliet. J Ultrasound Med 2011; 30:1637–1642
classic “rule out” ectopic algorithm
BhcG
β hCG >1500
β hCG <1500
mIU/mL
48 hour
f/u
US
IUP
Condous. BJOG. 112: 827-29. 2005
possible or
proven
ectopic
mIU/mL
You’re unlikely to see something if
the bhCG is low anyway
about 50% of IUPs will be diagnosed
when the β hCG < 1000 mIu/mL
http://www.acep.org/WorkArea/DownloadAsset.aspx?id=32886
about 50% of ectopics will have a
suggestive or diagnostic US when the β
hCG < 1000 mIu/mL
http://www.acep.org/WorkArea/DownloadAsset.aspx?id=32886
Isn’t it unlikely that the patient will
have an ectopic with a bhCG below
the discriminatory zone, anyway?
no
ectopics often have lower
β hCGs than IUPs
mean EP
mean IUP
1886 mIU/mL 30,512 mIU/mL
Kohn. Academic Emergency Medicine. 2003. 10(2)
Well, isn’t the risk of rupture of an
ectopic pregnancy low if the bhCG is
low?
no
rupture has been reported
at 10 mIU/mL and 189,720 mIU/mL
Barnhart. Obstetrics and Gynecology. 1994. 84(6)
classic “rule out” algorithm
US
>1500 mIU/mL
< 1500 mIU/mL
48 hour
f/u
US
IUP
Condous. BJOG. 112: 827-29. 2005
presumed
or proven
ectopic
are there studies showing harm
with the deferred ultrasound
approach?
no high quality studies have looked at
harm
• 37 patients had no deaths or
hemodynamic instability despite d/c and
median wait of 14 hours for US *
• 69 patients had a mean delay of 5.2 days
to diagnosis of ectopic with no deaths **
* Hendry JN, Naidoo Y. Emerg Med. 2001;13:338-343.
** Barnhart et al. Obstet Gynecol. 1994;84:1010-1015.
ACEP clinical policy 2012
Should the emergency physician obtain a
pelvic ultrasound in a clinically stable
pregnant patient who presents to the ED with
pelvic pain and/or vaginal bleeding and a βhCG below any discriminatory threshold?
Level C recommendation: Perform or obtain
a pelvic ultrasound for symptomatic pregnant
patients with a β-hCG below any
discriminatory threshold
back to the case
modern “rule out” ectopic algorithm
US
β hCG pending
normal or
suggestive
48 hour or
abnormal
US
f/
indeterminat
IUP,
diagnositic
e
molar
of ectopic
IUP
Condous. BJOG. 112: 827-29. 2005
what if you saw this?
or this?
what do you do with an
indeterminate US,
or a
pregnancy of unknown location?
ACEP clinical policy 2012
In patients who have an
indeterminate transvaginal
ultrasound, what is the diagnostic
utility of β-hCG for identifying
possible ectopic pregnancy?
risk of ectopic pregnancy with indeterminate US
β-hCG
Threshold
1,000
mIU/mL
1,500
mIU/mL
2,000
mIU/mL
3,000
mIU/mL
Relative Risk
of Ectopic
Below
Threshold*
(95%CI)
Study
Author
Year
Likelihood Ratios (95%CI)
Class
N
Condous28 2005
II
527
Dart24
2002
II
635
0.6 (0.3 – 1.1)
7.1 (3.4 14.9)
Kaplan3
1996
II
72
3.8 (1.4 - 9.8)
Mol32
1998
II
262
0.4 (0.2 - 0.5)
Dart35
1998
III
220
2.2 (1.0 - 4.5)
Negative†
0.9 (0.8 1.0)
2.3 (1.9 2.7)
2.5 (1.4 4.5)
0.7 (0.5 0.8)
1.8 (1.1 –
2.9)
0.4 (0.2 – 0.9)
0.9 (0.8 –
1.0)
2.3 (1.1 –
4.9)
0.9 (0.8 –
1.0)
0.6 (0.5 –
0.8)
0.8 (0.5 1.3)
0.7 (0.5 0.9)
2.3 (0.9 –
5.7)
Condous
28
Condous
28
2005
II
527
2005
II
527
0.5 (0.2 – 1.1)
Mol32
1998
II
262
0.2 (0.1 - 0.3)
Mateer26
1995
III
41
0.6 (0.2 - 1.4)
Mateer33
1996
III
95
0.5 (0.3 - 0.8)
Wang
27
Dart34
2011
II
141
1.3 (0.6 - 2.6)
1997
III
194
2.1 (0.9 - 4.8)
1.1 (0.8 –
1.5)
1.4 (1.0 –
1.8)
Positive‡
1.7 (0.9 –
3.1)
0.3 (0.2 –
0.5)
0.5 (0.2 –
0.9)
3.1 (2.0 - 4.8)
0.7 (0.5 - 1.0)
25 (7.9 – 81)
1.8 (0.7 - 4.8)
2.3 (1.2 - 4.3)
0.8 (0.5 - 1.4)
0.6 (0.3 - 1.1)
ACEP clinical policy 2012
In patients who have an indeterminate
transvaginal ultrasound, what is the diagnostic
utility of β-hCG for identifying possible ectopic
pregnancy?
Answer: Diagnostic utility is poor
Level C recommendation: Obtain specialty
consultation or arrange close outpatient follow
up for all patients with an indeterminate pelvic
ultrasound
what other ways can we risk stratify
patients with indeterminate US
(regardless of β hcG)?
excluded IUP: yolk sac or fetal pole
excluded EP: ectopic gestational sac, complex mass
discrete from ovary, any echogenic fluid, moderate
anechoic fluid
art and Howard. Acad Emerg Med. 1998. 5:313-319.
excluded IUP: yolk sac or fetal pole
excluded EP: ectopic gestational sac, complex mass
discrete from ovary, any echogenic fluid, moderate
anechoic fluid
art and Howard. Acad Emerg Med. 1998. 5:313-319.
spectrogram of diagnostic certainty
Small to
nonmoderate
specific
anechoic
nothing in
intrauterine
free fluid
the uterus
debris/sac,
or
or adnexa
no adnexal
nonmass
specific
nonadnexal ectopic
specific
nothing in mass
IUP
pregnanc
intrauterine the uterus
y
debris/sac
Indeterminate US
evaluation and disposition ends up being
determined by your gestalt based on patient’s
clinical (and social) state, hospital and clinic
system
patient was sent home, and returns 2 days
later…
I passed a lot of tissue at home
β hCG 1140 mIU/mL
I think she completed. She
passed POC at home and
there’s just echogenic material
in the uterus on ultrasound.
6% of patients with a suspected
“complete miscarriage” had an ectopic
pregnancy
152 patients
with
clinically
suspected
“complete
miscarriage
”
US with
empty uterus
Mean β hCG
of 524 mIU/ml
94% complete
6% ectopic
It’s not complete until the βhCG is 0
Condous. BJOG. 112: 827-29. 2005
Rhogam
http://www.acep.org/WorkArea/DownloadAsset.aspx?id=32886
90% of alloimmunization occurs at delivery
ACOG concluded that alloimmunization is
exceedingly rare after threatened ABs in first
trimester
Higher rates of fetomaternal hemorrhage with
complete AB compared with threatened AB
Rhogam
http://www.acep.org/WorkArea/DownloadAsset.aspx?id=32886
In patients receiving methotrexate for confirmed or
suspected ectopic pregnancy, what are the
implications for ED management?
• MTX is relatively contraindicated in patients with an
ectopic gestational sac larger than 3.5 cm or with
embryonic cardiac motion seen on US
• Treatment success rates are lower in patients who have a
β-hCG of 5,000 mIU/L or more
• Often need repeat dosing until β-hCG is decreasing
• Best estimates of failure rates appx 10%
• Rupture reported to range from 0.5 – 19%, probably < 5%
In patients receiving methotrexate for confirmed or
suspected ectopic pregnancy, what are the
implications for ED management?
(1) Arrange outpatient follow-up for patients who
receive methotrexate therapy in the ED for a
confirmed or suspected ectopic pregnancy
(2) Strongly consider ruptured ectopic
pregnancy in the differential diagnosis of
patients who have received methotrexate and
present with concerning signs or symptoms
1) don’t consider low β hCG low risk
2) consider a pelvic US for patients with any β hCG
3) your approach to the patient with a low β hCG will
be determined by your US skills, comprehensive
US availability, department protocol, clinical risk
factors and findings
4) your approach to the patient with a PUL will also be
determined by US skills, hospital protocols and
resources, clinical risk factors and findings
5) a miscarriage is not complete until it’s complete
6) you probably don’t need to give rhogam for
threatened AB
7) consider rupture in symptomatic patients s/p MTX