ROLE OF EARLY PREGNANCY ULTRASOUND FOR PREDICTION OF EARLY

MISCARRIAGE

THESIS SUMMARY
THE DIPLOMATE OF NATIONAL BOARD
OBSTETRICS AND GYNECOLOGY

DR. RAUT ANKUSH NANDKISHOR

(DNB REG. NO. 225-26104-142-201591 DATE: 28/08/2015)
DNB RESIDENT
DEPARTMENT OF OBSTETRICS & GYNECOLOGY
TATA MAIN HOSPITAL
JAMSHEDPUR

SUMMARY OF DNB THESIS

1. Name of Specialty
2. Area of interest
3. Title of Thesis
4.

Year of submission

: Obstetrics and Gynecology

: Miscarriage prediction
: Role of early pregnancy ultrasound for
prediction of early miscarriage
: 28 AUG 2014

5. Name of the candidate

: Dr. Ankush Raut

6. Name of the Supervisor

: Dr. Mamta R Datta

7. Name of Hospital

: Tata Main Hospital, Jamshedpur

8. Aim of the study

: To study the role of early pregnancy ultrasound

for prediction of early miscarriage

9. Material & Method

Study site:
Department of Obstetrics and Gynecology, Tata Main Hospital,
Jamshedpur.
Study Population:
Women at gestational ages between 6 week 0 days to 10 week 6 days attending
our out patient department were included in this study.
Study Design:
Hospital based analytical observational prospective cohort study
Sample Size Calculation:
By assuming incidence of miscarriage in early pregnancy as 20% in pregnant
population with accepted standard error of 5% and power 80%, beta 0.2 and with
estimated annual early pregnancy patient population in our department with 3
consulting units as 2400. The sample size is calculated from below formula: 15(2)
n=[(Z alpha/2)2x P x (100-P)]/e2
=[(1.96)2x 20 x (100-20)]/52
=245.86

Z= standard deviation from mean(here consider 2 standard deviation)

P = Prevalence determine from previous study
e = accepted error (5%)
So we will need to analyse 246 women in early pregnancy.
In this study, we analyse, 400 women in early pregnancy.
Duration Of Study:
One year (1stNovember 2014 to 31st October 2015)
Inclusion Criteria:
Women who fulfilled the following criteria were included in the study:
Patient with certain dates (known LMP)
Regular menstrual cycles with a cycle between 26 and 30 days
Gestational age between 6 week 0 days to 10 week 6 days
No hormonal contraception use, pregnancy or breastfeeding in the 3
months preceding the LMP
Only those with spontaneous conception were included
Exclusion Criteria:
Women with following history were excluded from study:
Conceived after infertility treatment
History of irregular cycles
Not willing to participate in the study
Used of hormonal contraceptive or drugs for medical termination of
pregnancy within a period of 3 months before the present conception
Breastfeeding
History of recurrent miscarriages
Multiple pregnancy
Blighted ovum
Pregnancy with copper T in situ
Not willing for a transvaginal scan
Ectopic gestation

Ethical Issue:
We have strictly followed PRE-CONCEPTION AND PRE-NATAL DIAGNOSTIC
TECHNIQUES (PROHIBITION OF SEX SELECTION ) ACT,1994 and did not
misuse trans-vaginal ultrasound scan for sex detection by any means.
Methodology:
A thorough history regarding including demographic features, detailed obstetric and
menstrual histories and pregnancy symptoms was taken. All women underwent a

transvaginal ultrasonography(TVS) using a 5-MHz transducer for B-mode imaging

(Aloka SSD 900,2000, 4000; Aloka, Tokyo, Japan) as part of the pregnancy
assessment to determine pregnancy location, viability and gestation at age. The
number of embryos was documented and multifetal pregnancies were excluded from
study. Measurement of fetal crown to rump length (CRL), gestational sac
diameter(GSD), yolk sac diameter(YSD) and fetal heart rate(FHR) was performed.
All observations were performed by a single observer.
Two ultrasounds were performed. First was a TVS at enrolment of the women into the
study. The second ultrasonography was other either TVS or TAS at 12 weeks 6 days
and beyond, to demonstrate continuation of pregnancy or otherwise. End point of
study was continuation of pregnancy beyond 12 weeks 6 days gestational age till 20
weeks of gestation.
Primary outcome:
Continuation of pregnancy beyond 12 weeks 6 days as determined by routine
ultrasound scan at or beyond 13 weeks 0 days of gestation.
Early pregnancy failure:
Sonographic diagnosis of embryonic demise was made when there was no
cardiac activity in an embryo greater than 5 mm by transvaginal ultrasound or 9 mm
by abdominal ultrasound(89). Transvaginal sonographic diagnosis of a blighted ovum
was certain when the mean gestational sac diameter exceeded 8 mm without a yolk
sac or when the mean gestational sac diameter exceeded 16 mm without an embryo.
Transabdominally, a gestational sac greater than 20 mm without a yolk sac or 25 mm
without an embryo was diagnosed as blighted ovum(90).
Statistical Analysis:
Data was entered in social science system version SPSS 20.0. Continuous variables
were presented as mean+ standard deviation and categorical variables were presented
as absolute numbers and percentage. The comparison of normally distributed
continuous variables between the groups was performed using student`s t test.
Nominal categorical data between two groups were compared using Fischer`s exact
and Chi-squared test. Correlation was done between various variables (GSD<5 TH
percentile, YSD > 95th percentile, FHR<5th percentile, CRL less than 5th percentile,
etc). A p value of 0.05 was considered statistically significant.
Multiple logistic regression analysis was performed to determine the independent
variables that contributed to the miscarriage.
Receiver operating characteristic (ROC) curves were used to assess the ability of FHR
and GSD-CRL difference to predict continuation of pregnancy. The best cut-off point
of FHR and GSD-CRL difference to predict continuation of pregnancy was determine.
R2 (Coefficient of determination) was calculated to predict percentage of increased
risk of miscarriage with every 10 bpm decrease in FHR below 130 bpm.
10. Salient Findings:
This study was conducted in the Department of Obstetrics and Gynecology,Tata Main
Hospital, Jamshedpur, from August 2014 to November, 2015. This study was

undertaken to evaluate the role of early pregnancy ultrasound parameters of crown to

rump length(CRL), yolk sac diameter(YSD), gestational sac diameter(GSD) and fetal
heart rate(FHR) for the prediction of early miscarriage in Indian women. A total of
400 women were studied .
Seventy women(17.5%), out of a total of 400 women who participated in our study,
had miscarriage.

Women with spotting or slight vaginal bleeding did not have significant
correlation with miscarriage(odds ratio of 1.483 and 1.625 respectively and
p=0.4512 and 0.4023 respectively)
Mean gestational sac diameter was significantly smaller in miscarriage(n 1)
group compared to continued pregnancy(n2) group(21.97+9.38mm vs
32.06+10.34mm, p<0.0001).
Gestational sac diameter less than 5th percentile, with other parameters within
5th to 95th percentile, had odds ratio 0.3541 and did not correlate significantly
with miscarriage.
Crown to rump length in miscarriage(n 1) group was significantly smaller than
in continued pregnancy(n2) group (11.18+9.02mm vs 18.67+10.40mm,
p<0.0001).
Crown to rump length less than 5th percentile, with other parameters within 5th
to 95th percentile, had odds of 1.478 for miscarriage (p=0.513). This suggested
that only small CRL less than 5th percentile was not a predictor of miscarriage.
Fetal heart rate was significantly slower in miscarriage group(n1) compared to
continued pregnancy(n2) group(117.68+ 23.96bpm vs 152.52+15.90bpm,
p<0.0001).
Fetal heart rate less than 5th percentile, with other parameters between 5th and
95th percentile, for corresponding gestational age had a sensitivity of 15.71%,
specificity of 98.18%, positive predictive value of 64.71%, negative predictive
value of 84.60% and odds ratio of 10.068 for miscarriage (p<0.001). This
suggested that fetal heart rate less than 5 th percentile, with other parameters
within 5th and 95th percentile, had significant correlation with miscarriage.
Receiver operator characteristic curve showed that FHR of 128bpm was the
optimum cut off for continuation of pregnancy.
The coefficient of determination(R2) was 0.2672.This suggested that there
was 26.72% chance of miscarriage for every 10 bpm decrease in FHR below
130 bpm.
Mean yolk sac diameter was significantly larger in miscarriage(n 1) group as
compared to continued pregnancy(n2) group(4.89+0.97mm vs 4.66+0.76mm,
p=0.031), except at 49 to 55 days and 63 to 69 days of gestational age (p=0.15
and 0.20 respectively).
Yolk sac diameter more than 95th percentile, with other parameters within 5th to
95th percentile, had odds of 0.061 for miscarriage (p<0.7408). Therefore, only

YSD more than 95th percentile, with other parameters within 5th to 95th
percentile, did not have significant correlation with miscarriage.
Gestational sac diameter-CRL difference was significantly smaller in
miscarriage(n1) group
as compared to continued pregnancy(n2)
group(10.89+5.68mm vs 13.85+4.73,p=0.001), but GSD-CRL difference was
not significant at 42 to 49 days and 70 to 76 days of gestation (p=0.1047 and
0.2257).
Prediction sensitivity for miscarriage was 14.29%, 40.00%, and 24.29% for
Gestational sac-CRL difference 5mm, 10mm and 15 mm respectively.
Specificity for prediction of miscarriage (96.67%) & odds ratio(4.883) was
highest for GSD-CRL difference <5mm.
Receiver operator characteristic curve for GSD-CRL difference showed that
GSD-CRL difference of 12mm was the optimum cut off for continuation of
pregnancy.
Evaluation of the combination of two abnormal parameters shows that CRL
less than 5th percentile alongwith FHR less than 5 th percentile, with other
parameters within 5th to 95th percentile, had the highest odds ratio for
miscarriage prediction( odds ratio:66.61). This combination had a sensitivity
of 8.57%, specificity of 100%, positive predictive value of 100%, negative
predictive value of 83.76 and a relative risk of 6.156 for miscarriage
prediction.
Evaluation of combination of three abnormal parameters shows that
combination of CRL, GSD and FHR less than 5 th percentile, with YSD within
5th to 95th percentile, had the highest odds ratio for miscarriage
prediction( odds ratio:34.2). This triple combination had a sensitivity of
4.28%, specificity of 100%, positive predictive value of 100%, negative
predictive value of 82.12% and a relative risk 5.92 for miscarriage prediction.
A combination of all four abnormal parameters, i.e.,GSD, FHR, CRL less than
5th percentile and YSD more than 95th percentile, had a sensitivity of 5.92%,
specificity of 100%, positive predictive value of 100%, negative predictive
value of 83.12% and odds ratio of 34.27for prediction of miscarriage. High
specificity of above combination suggests absence of above parameters can
predict continuation of pregnancy.
Multiple regression analysis showed that CRL less than 5th percentile, FHR
less than 5th percentile and FHR less than 130 bpm are most significant factors
which affect continuation of pregnancy.

11. Conclusion:
This prospective study showed that pregnancies with crown to rump length less than
5th percentile, mean gestational sac diameter less than 5 th percentile, fetal heart rate
less than 5th percentile and yolk sac diameter more than 95 th percentile for
corresponding gestational age are at increased risk of miscarriage. Pregnancies with
gestational sac diameter- crown rump length(GSD-CRL) difference less than 5mm

and fetal heart rate less than 130bpm at any gestation were at increased the risk of
miscarriage.
Pregnancy at risk of miscarriage should have appropriate care. Till the date there is no
consensus in the most effective intervention for prevention of miscarriage. At risk
pregnancies identified by early ultrasound may form the basis for further intervention
studies evaluating prevention of pregnancy loss. So, there is a need of a multi-centric
study with larger sample size for confirming these findings.
12. Recommendations:

Early pregnancy ultrasound should be done in every pregnancy.

Crown to rump length, mean gestational sac diameter, yolk sac diameter and
fetal heart rate should be measured.
Pregnancies which are identified at risk by early ultrasound should be given
appropriate care and counselling.
Multi-centric study with larger sample size for confirming our study findings.
Intervention studies evaluating prevention of pregnancy loss.
13. Limitation of study:
Small sample size is the most important limitation of our study.
Improving prognosis of at risk pregnancy identified by early ultrasound needs
evaluation by further studies on therapeutic interventions in such at risk
pregnancies in order to add therapeutic value to the prognostication offered by
early pregnancy ultrasound .