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Bleeding in the first trimester of pregnancy
Wieringa-de Waard, M.
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Wieringa-de Waard, M. (2002). Bleeding in the first trimester of pregnancy
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Download date: 16 Jun 2017
CHAPTERR 3
Threatenedd miscarriage in general practice
diagnosticdiagnostic vaiue of history taking and physical
examination examination
Margreett Wieringa-de Waard, Gouke J. Bonsel, Willem M. Ankum,
Jeroenn Vos, Patrick J. E. Bindels
Submittedd for publication
Abstract t
OBJECTIVESS To determine the diagnostic value of history taking and physical examinationn in first-trimester bleeding, for differentiating between patients requiring immediatee further diagnostic examination from those in whom an expectant policy will
initiallyy suffice.
DESIGNN Prospective population based cohort study.
SETTINGG 74 General practices in Amsterdam.
PARTICIPANTSS Pregnant women with first-trimester bleeding.
RESULTSS 225 patients with first-trimester vaginal bleeding were referred for an early
pregnancyy assessment and the data of 204 were analysed.
Threee approaches (models) were explored to identify diagnostic subgroups relevant
too clinical practice. Model 1 distinguishes between viable pregnancies and complete
miscarriagess on the one hand (expectant policy possible) and all other diagnoses on
thee other (further diagnostics required). By using this model the pre-test probability
off viable pregnancies and complete miscarriages combined, increased from 72% to
77%% post-test. Model 2, which separates viable pregnancies from other diagnoses,
enabledd an increase from a 47% pre-test probability to a post-test probability of
70%.. Model 3, enabling the identification of complete miscarriages, showed a posttestt probability of 4 1 % of a complete miscarriage, given a pre-test sample probabilityy of 25%. The tentative diagnosis of the GP, based entirely on clinical judgement,
turnedd out to be a poor predictor for the ultrasonographically confirmed diagnosis
(pre-testt probability of 47% changed to a post-test probability of 58%).
CONCLUSIONSS This study shows that in first-trimester bleeding neither statistical
predictionn models based on signs and symptoms, nor clinical judgement can validly
replacee ultrasonographic assessment in establishing a diagnosis.
25 5
CHAPTERCHAPTER 3
Introduction n
First-trimesterr vaginal bleeding is the most common problem in pregnancy, almostt always leading to a consultation in the general or gynaecological practice.
Thee problem occurs in about one-fifth of all pregnancies, with an estimated
miscarriagee rate of about 50%, while the other 50% of pregnancies continue
withoutt serious problems. 1 Ultrasonography, the gold standard for establishing
aa diagnosis in first-trimester vaginal bleeding, is not always immediately
available.. In these circumstances, the patient's medical history and a gynaecologicall examination are used to make a provisional diagnosis and to decide
whetherr referral for any further clinical assessment, i.e. ultrasonographic
examination,, is needed. To date virtually no information is available on the
discriminativee capacity of clinical symptoms and gynaecological examination in
differentiatingg between the various underlying diagnoses, e.g. viable or nonviablee pregnancy, complete or incomplete miscarriage or ectopic pregnancy. 2
Inn this paper we present a prospective population-based cohort study of otherwisee unselected women, presenting in general practice with first-trimester
bleeding,, who were referred to our unit for ultrasonographic assessment. We
analysedd whether the patient's history and physical examination were of any
usee in predicting the final diagnosis. In addition, we analysed the skills of the
attendingg GPs in making a provisional diagnosis of a viable pregnancy on
clinicall grounds before referring the patient.
Methods s
Patients Patients
Ourr study was conducted as part of a randomised trial on the management of
miscarriagess in two Amsterdam hospitals, the Academic Medical Center and
thee Onze Lieve Vrouwe Gasthuis, between April 1998 and September 2000.
Seventy-fourr GPs working in the health district covered by these two hospitalss participated in the study. They referred all women with vaginal bleeding,
aa positive urinary pregnancy test result, and a gestational age of less than 16
weeks,, for ultrasonographic assessment. Oral informed consent was obtained
inn all patients.
Thee study was approved by the medical ethics committees of both hospitals.
DataData collection
Duringg the first consultation, the participating GPs collected base line data
onn a structured form on clinical signs and symptoms, obstetric history and
gestationall age. Additional findings from the gynaecological examination
weree recorded. With regard to the gynaecological examination GPs had the
possibilityy to fill out 'not performed' on the form. A provisional diagnosis was
thenn made, and the GP was asked to estimate the probability of a viable preg-
26 6
ThreatenedThreatened miscarriage in general practice
nancyy being present on a 0-100% scale. Information on sociodemographic data
wass collected by means of a patient questionnaire.
UltrasoundUltrasound
examination
AA standardised transvaginal sonographic examination was performed by trained
physicianss using a transvaginal 6.5 MHz sonographic probe (Hitachi Corporation,, Tokyo, Japan). A viable pregnancy was diagnosed whenever fetal heart
activityy could be detected. A non-viable pregnancy was diagnosed in case of
ann immeasurable embryonic pole at a gestational sac diameter > 15 mm, an
embryoo without cardiac activity, or an empty gestational sac at a diameter <
155 mm not showing any growth after a seven-day interval. 3,4 An incomplete
miscarriagee was diagnosed in case of sonographic evidence of retained productss of conception (RPOC) > 15 mm anteroposterior (AP) diameter.
AA complete miscarriage was diagnosed in case of sonographic evidence of
RPOCC < 15 mm (AP diameter) in combination with previous sonographic
documentationn of an intra-uterine pregnancy (IUP) or with decreasing serum
betaa human chorionic gonadotrophin (hCG) concentrations during follow-up.
AA diagnosis of ectopic pregnancy was considered if no intra-uterine gestationall sac was seen, or if an ectopic gestational sac was seen, or if an ectopic mass
wass visualised, together with a serum hCG concentration > 1.500 IU/L. 5
Thee ultrasonographic diagnosis of hydatidiform mole had to be confirmed by
histopathologicall examination.
StatisticalStatistical
analysis
Ourr prospective approach implies that we analysed all cases, including relativelyy rare conditions, e.g. ectopic pregnancy and hydatidiform mole, which
shouldd be considered in differential diagnosis of first-trimester bleeding.
Wee analysed three models, which were constructed to classify women presentingg with first-trimester bleeding into a group in whom an expectant policy
cann be justified and a group in whom further ultrasonographic assessment is
required. .
Modell 1 aims as the first step to separate viable pregnancies together with
completee miscarriages from the rest of the study population, thereby assumingg that these women do not require immediate sonographic assessment.
Afterr the first step model 1 would be further explored to separate viable
pregnanciess from complete miscarriages.
Modell 2 tries to predict the presence of a viable pregnancy, while model 3
triess to separate complete miscarriages from all remaining diagnoses.
Thee relationship between patient characteristics, clinical variables, findings
fromm gynaecological examination and the diagnosis was analysed, starting
withh an univariate regression analysis. All variables with a p-value < 0.10
weree selected for further multivariate analysis. Prior to multivariate modelling,, the multicollinearity of potential predictive variables was checked
27 7
CHAPTERCHAPTER 3
Tablee 3 . 1 . Patient characteristics according to the sonographically confirmed
diagnosis. 3 3
Complete e
No n-viable
o
Viable e
Ectopic c
e
pregnancy ymiscarriage e pregnancy y pregnancy 0 0
(nn = 8)
(nn = 51)
)
( nn
( = 96)
( n=49)
(
Characteristic c
AgeAge - yr, mean
/29.3
/
3
30.9 9
56 6(58.3) )
25 5(26.0) )
15 5(15.6) )
300 (58.8)
144 (27.5)
7(13.7) )
33 (37.5)
44 (50.0)
11 (12.5)
25 5(51.0) )
14 4(28.6) )
10 0(20.4) )
54 4(56.3) )
28 8(29.2) )
14 4(14.6) )
388 (74.5)
77 (13.7)
66 (11.8)
33 (37.5)
22 (25.0)
33 (37.5)
33 3(67.3) )
10 0(20.4) )
6 6(12.2) )
--
--
(41.2)
(41.2)
(9.8)
(7.8)
66 (75.0)
11 (12.5)
-11 (12.5)
10 0(20.4) )
23 3(46.9) )
8 8(16.3) )
8 8(16.3) )
29(56.9)
5 (9.8)
11(21.6)
6(11.8)
3(37.5)
1 (12.5)
2(25.0)
2(25.0)
27(55.1)
5 (10.2)
9(18.4)
8(16.3)
34.0 0
31.4 4
Parity Parity
00
11
>1 1
PriorPrior
miscarriage
00
11
>1 1
Prior Prior
ectopicectopic
1 1 (1.0) )
pregnancy
--
GestationalGestational age
35 5(36.5) )
37 7(38.5) )
12 2(12.5) )
12 2(12.5) )
< 88 wk
8-122 wk
12-166 wk
Uncertain n
NativeNative
country
Western-Europe e
48(50.0)
andd USA
11 (11.5)
Africann country
Surinamm and Antilles 26(27.1)
Otherr and unknown 11(11.5)
aa
bb
211
211
55
44
Values are numbers with percentages in parentheses.
Non-viable pregnancies; two hydatidiform mole pregnancies included.
withh a conventional correlation analysis (threshold 0.4). In case of multicollinearityy the variable with the highest clinical face validity and/or ease of
determinationn in primary care was selected. The level of significance for the
multivariatee model was set at 0.05. With the variables, identified with multivariatee regression analyses as independent predictors, Receiver-OperatingCharacteristicc (ROC) curves were made, describing the relationship between
sensitivityy and specificity for each model. We regarded the point with the
28 8
ThreatenedThreatened miscarriage
in general
lowestt sum of false-positives plus false-negatives (highest accuracy) as the best
thresholdd in the ROC curve.
Inn addition, the diagnostic performance of model 2 was compared with the
GPs'' estimation of the probability of a viable pregnancy being present.
Thee Statistical Package of the Social Sciences (SPSS, version 9.0) was used
forr all analyses.
Results s
Outt of 225 women referred by GPs for an early pregnancy assessment, 217
weree eligible for the study; eight women with a negative hCG pregnancy test
weree excluded. Of these 217 women 13 were excluded; two were lost to follow-upp before a final diagnosis was made and 11 because of an unacceptably
highh number of missing data. Of the remaining 204 women, 96 (47%) had a
viablee pregnancy, 51 (25%) a complete miscarriage, 47 (23%) a non-viable
pregnancy,, two (1%) a hydatidiform mole, while eight women (4%) had an
ectopicc pregnancy.
Noo significant differences in patient characteristics were observed between
womenn with viable pregnancies, complete miscarriages and non-viable pregnanciess (Table 3.1). The number of women with ectopic pregnancies was too
smalll for a meaningful comparison.
Inn Table 3.2 the univariate analysis according to the three pre-specified predictivee models are presented. For gynaecological examination the possibility
wass given to fill out 'not performed'. Vaginal examination was performed in
57.4%% and speculum examination in 61.3% of the cases. Performed or not
performedd was not different between the diagnosis groups.
Tablee 3.3 shows the results of the multivariate regression analyses.
Forr model 1, we found both stable bleeding (OR: 0.3) and increasing bleeding
(OR:: 0.4) to be independent predictors of the group of viable pregnancies and
completee miscarriages.
Inn model 2, independent predictors of a viable pregnancy were stable and
increasingg bleeding (OR: 0.4 and OR: 0.1 respectively). The absence of blood
att speculum examination was also negatively associated with a viable pregnancyy (OR: 0.4). A negative history of passing blood clots was a predictor of a
viablee pregnancy (OR: 2.2).
Forr model 3, independent predictors of a complete miscarriage were stable or
increasingg bleeding (positively associated) and a negative history of passing
bloodd clots (negatively associated).
Inn Figure 3.1, the ROC curves of the three models and the ROC curve for the
predictionn of the GPs are shown.
29 9
practice
CHAPTERCHAPTER 3
Tablee 3.2. Univariate logistic regression analyses in three models 3 .
Onlyy Odds ratios with p-values < 0.10 are reported. 0
Modell 1
Modell 2
Modell 3
0.99 (0.9-10) )
0.99 (0.9-1.0)
NSC C
NS S
NS S
NS S
11
2.00 (1.0-4.0)
1.33 (0.6-2.9)
11
0.44 (0.2-1.0)
0.66 (0.2-1.6)
11
0.33 (0.1-0.7)
0.44 (0.2-1.0)
11
0.33 (0.2-0.6)
0.11 (0.0-0.2)
11
1.77 (0.7-4.1)
7.11 (2.3-17.3)
NS S
NS S
NS S
11
0.22 (0.1-0.5)
0.6(0.3-1.5) )
11
6.22 (2.6-14.4)
3.66 (1.4-8.9)
bloodblood clots
HistoryHistory of passing
NS S
yes s
NS S
no o
11
3.33 (1.7-6.3)
11
0.22 (0.1-0.5)
NS S
NS S
11
2.44 (1.0-5.5)
AgeAge (per year)
PriorPrior
miscarriage
00
11
>1 1
Bleeding Bleeding
decreasing g
stable e
increasing g
Bleeding Bleeding
lesss than period
similarr to period
moree than period
BloodBlood colour
NS S
NS S
brown n
redd and brown
HistoryHistory of passing tissue mass
yess
noo
AbdominalAbdominal
NS
NS
CourseCourse of abdominal
30 0
1
0.2(0.1-0.6)
pain
NS S
NS S
NS S
NS S
11
0.5(0.3-1.0) )
11
2.55 (0.9-7.1)
1.00 (0.5-2.2)
2.55 (0.7-9.4)
NS S
NS S
NS S
NS S
11
1.55 (0.6-3.8)
2.11 (1.0-4.5)
1.99 (0.7-5.8)
yes s
no o
noo pain
decreasing g
stable e
increasing g
11
4.3(1.4-13.3))
pain
ThreatenedThreatened miscarriage in general practice
Modell 1
LocationLocation of abdominal
nott done
done,, no blood
done,, blood
SpeculumSpeculum
nott done
done,, no clots
done,, clots
SpeculumSpeculum
NS S
NS S
11
NS S
NS S
NS S
NS S
NS S
NS S
2.9(1.1-7.8) )
1.66 (0.8-3.4)
1.4(0.4-4.8) )
NS S
NS S
11
1.66 (0.9-2.9)
NS S
NS S
examination
done e
nott done
SpeculumSpeculum
Modell 3
pain
noo pain
nott in the middle
(unilateral) )
middle e
difficultt to say
SpeculumSpeculum
Modell 2
examination
11
0.88 (0.3-2.0)
0.55 (0.3-1.1)
examination
0.66 (0.3-1.1)
0.44 (0.1-1.6)
0.7(0.4-1.2) )
0.11 (0.0-0.8)
0.99 (0.5-1.9)
3.2 2(0.8-12.1) )
11
0.66 (0.3-1.1)
1.11 (0.4-2.8)
NS S
NS S
NS S
NS S
NS S
NS S
NS S
11
0.66 (0.2-1.8)
0.66 (0.3-1.1)
NS S
NS S
NS S
examination
nott done
11
done,, no erosion of the cervi>[0.55 (0.2-1.0)
done,, erosion of the cervix
0.88 (0.3-2.3)
VaginalVaginal digital
done e
nott done
examination
VaginalVaginal digital
examination
nott done
done,, cervix open
done,, cervix closed
11
11
2.00 (0.8-4.8) 0.11 (0.0-0.9)
0.44 (0.2-0.8) 1.66 (0.8-3.0)
11
1.77 (0.9-3.3)
11
0.66 (0.2-2.3)
0.55 (0.3-1.0)
aa
95% CI in parentheses.
Model 1: viable pregnancy and complete miscarriage versus ectopic and non-viable
pregnancy.. Model 2: viable pregnancy versus all other diagnoses. Model 3: complete
miscarriagee versus all other diagnoses. The three models included all characteristics
(Tablee 3.1) as well as the variables feeling pregnant and period of pain and bleeding
untill consultation of the GP.
cc
NS denotes 'not significant'.
bb
31 1
CHAPTERCHAPTER 3
Tablee 3.3. Multivariate logistic regression analyses in three models. a ' b
Modell 1
Bleeding Bleeding
decreasingg
stablee
increasingg
Model 3
1
0.4(0.2-0.8)
0.1(0.0-0.3)
1
1.5(0.6-3.8)
4.9(1.9-12.7)
HistoryHistory of passing blood clots
yes s
noo
11
2.2(1.0-4.6)
1
0.4(0.2-0.8)
SpeculumSpeculum
nott done
done,, no blood
done,, blood
1
1.0(0.4-2.9)
0.4 (0.2-0.8)
aa
1
0.3(0.2-0.7)
0.4(0.2-1.0)
Model 2
examination
Results expressed in Odds ratio (95% CI).
Model 1: viable pregnancy and complete miscarriage versus ectopic and non-viable
pregnancy.. Univariately significant variables used as input were: age, amount of
bleeding,, course of abdominal pain, and blood at speculum examination. Model 2:
viablee pregnancy versus all other diagnoses. As input were used the variables age,
priorr miscarriage, amount of bleeding, history of passing blood clots, and blood at
speculumm examination. Model 3: complete miscarriage versus all other diagnoses.
Variabless used as input were prior miscarriage, amount of bleeding, history of passingg blood clots, blood colour, abdominal pain, and blood at speculum examination.
Duee to multicollinearity we removed four, six and six variables, respectively, from the
variabless selected with univariate analyses.
bb
Modell 1: The optimal point in the ROC curve of this model, which tried to
distinguishh between viable pregnancies together with complete miscarriages
andd other diagnoses, is the point with a sensitivity of 80% and a specificity of
40%,, which resulted in a positive likelihood ratio (LR + ) of 1.3. The pre-test
probabilityy of 72% (percentage of viable pregnancies and complete miscarriagess in the study) changed to a post-test probability of 77%.
Modell 2: The optimal point in the ROC curve of this model, which predicted
thee presence of viable pregnancies, showed a sensitivity of 68% and a specificityy of 74% (LR + 2.6). By using this model, the pre-test probability of a
viablee pregnancy changed from 47% to a post-test value of 70%.
Modell 3: The best threshold in the ROC curve of this model, separating completee miscarriage from all other diagnoses, has a sensitivity of 78% and a
specificityy of 65% (LR 2.2 + ). The probability of a complete miscarriage
increasess from 25% pre-test to a post-test value of 41%.
Inn the ROC curve describing the prediction by GPs of a viable pregnancy
32 2
ThreatenedThreatened miscarriage
in general
100-1 1
s o -ar r
££
in in
//
4 0 --
i;
//
60-
"55 5
//
//
^
""
/
/
/
/
/
Modell 1
Modell 2
2 0 --
Modell 3
Gp p
200
TT
40
TT
60
ii
80 0
100 0
11 -specificity
Figuree 3 . 1 . ROC curves of the pre-specified models and of the GP prediction. Model 1
aimss to distinguish between viable pregnancies and complete miscarriages on the
onee hand and all other diagnoses on the other, model 2 tries to predict viable pregnanciess and model 3 distinguishes complete miscarriages from all other diagnoses.
Thee GP model shows the prediction of a viable pregnancy by GPs.
beingg present, the best point, with a sensitivity of 89% and a specificity of
42%,, gives an LR + of 1.5. This changes the pre-test probability of 47% to a
post-testt probability of 58%, which is worse than the post-test probability of
70%% in model 2.
Thee weak relation between the prediction by model 2 and by the GPs' estimatess on a viable pregnancy being present, is illustrated in a scatter plot
(Figuree 3.2).
Discussion n
Inn this prospective study of pregnant women with first-trimester bleeding we
triedd to develop diagnostic rules based on the patient's history and physical
examinationn to enhance the efficiency of referral for ultrasonographic assessment.. ROC curve analysis showed that even the best of the pre-specified
33 3
practice
CHAPTERCHAPTER 3
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O
AO-
--a>--CSO O
0.88
O—A-
a. a.
ÜÜ
cc
o o 0 . 6 -uu
nr®
A A DD
ok
T5 5
0) )
i --
Q. .
--
--m---AAO-
n no
O
-A-Ak-A-A
AA
CDD D
AA
0.22
oo
--
AAA
A
Gk
aa
-a--aaa
-m----
- A - A * > - - A A AA
22
CQO O
--
--
-o--
AO O
1
0.4
0.6
0.8
1.0
Predictionn model 2
OO viable pregnancies
other diagnoses
Figuree 3.2. Scatter plot of the prediction of a viable pregnancy by GPs versus predictionn of a viable pregnancy by model 2.
modelss had insufficient discriminative power to be of any use in clinical practice.
T h ee possibility that GPs might be able to discriminate between viable pregnanciess and other diagnoses in early pregnancy on clinical grounds, was rejected.
Inn model 1, which aims to identify p a t i e n t s for whom no referral is needed
(thosee with c o m p l e t e miscarriages and viable pregnancies), symptoms related
too t h e course and a m o u n t of bleeding have opposite significance for the two
diagnoses,, which most likely explains the insufficient discrimination. So a
furtherr exploration of this model to distinguish between viable pregnancy and
c o m p l e t ee miscarriage was not possible. However, models 2 and 3, designed to
identifyy e i t h e r viable pregnancies or complete miscarriages, also t u r n e d out
too b e of little v a l u e .
Althoughh the course of bleeding was an i n d e p e n d e n t predictor in all t h r e e
m o d e l s ,, t h e predictive power was low and not discriminative enough to rely
uponn in clinical decisions.
A n o t h e rr r e m a r k a b l e finding in our study was the very limited impact of the
34 4
ThreatenedThreatened miscarriage
in general
gynaecologicall examination in our models. Apparently this examination is of
noo diagnostic significance in first-trimester bleeding. However, we still regard
thiss examination as important for evaluating the degree of bleeding (to rule
outt emergency situations) and for finding products of conception in the vaginaa and the cervical os. In our study, in which GPs were asked to perform as
theyy did in normal practice, vaginal examination was only performed in
57.4%% and speculum examination in 61.3% of the cases. In a survey in
Wessexx about management of bleeding in early pregnancy 24% of the GPs
reportedd that they never performed a vaginal examination. A speculum
examinationn was never done by 38%. 2
Iff in our study gynaecological examination was performed in all cases, we can
nott exclude that the multivariate analysis had given more support for this
examination. .
AA potential drawback of our study was the delay between the measurements
off classifying variables and the ultrasonographic verification with a median
timee of two days (25-75 percentiles: 1-3 days), according to normal clinical
practicee in the Netherlands. Perhaps a better diagnostic performance could
bee achieved, especially in case of a complete miscarriage (model 3), without
delayy between GP consultation and sonographic assessment. However, it is
nott likely that the very low post-test probability of model 3 will increase in
suchh a way that clinical relevance might be reached. Also such a procedure
settingg may be feasible for research purposes, but has little relevance for
practicess without direct access to ultrasonographic facilities.
Wee were unable to pay specific attention to ectopic pregnancies, because of
thee limited number of cases. Earlier studies showed that a physical examinationn is insufficient too for diagnosing an ectopic pregnancy in the majority of
cases. 6 77 Highly suspect cases were usually referred directly to the gynaecologyy department and thus not included in our study. Of the eight ectopic pregnanciess diagnosed at our unit, only two were referred for suspected ectopic
pregnancy.. Three ectopic pregnancies were treated surgically (including the
twoo suspected cases), four self-limiting cases with declining serum hCG concentrationss were managed expectantly, and one ectopic pregnancy was treatedd with a single dose of methotrexate. The question as to whether it is acceptablee to withhold an immediate ultrasonographic assessment from patients
withh first-trimester bleeding, thereby postponing the diagnosis of ectopic
pregnancy,, can not be answered from our data.
Chungg found discrepancy in uterine size to be the most significant predictor
off non-viable pregnancies. 8 We also included this item in our Case Record
Form,, but could not confirm its prognostic value. In our study GPs did not
carryy out a vaginal examination in 37% of the cases. In the remaining 63% of
thee cases, GPs reported the uterine size to be according to gestational age in
32%,, indeterminate in 23%, while a discrepancy in uterine size was reported
inn only 8%. Our study differs from Chung's in both its setting (primary care
35 5
practice
CHAPTERCHAPTER 3
versuss secondary care) and in its analyses. We analysed all cases, including
ectopicc and molar pregnancies in order to resemble as much as possible the
situationn in which the physician has to make a decision in daily practice. The
variabless analysed in our study all derive from the standard management of
womenn with first-trimester bleeding and can easily be obtained.
Wee conclude that in a primary care setting clinical symptoms and physical
examinationn are not useful in predicting a diagnosis in first-trimester bleeding.. To establish a certain diagnosis, sonographic assessment is required.
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3.. Coulam CB, Goodman C, Dorfmann A. Comparison of ultrasonographic findings in
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4..
Deaton JL, Honore GM, Huffman CS, Bauguess P. Early transvaginal ultrasound
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