state of the art of first trimester pre-eclampsia
TRANSCRIPT
The Fetal Medicine
Foundation
Prof Fabricio Costa MD, PhD, FRANZCOG, COGU,
Diploma in Fetal Medicine (FMF-London, UK)
Department of Gynecology and Obstetrics
University of São Paulo at Ribeirão Preto
Brazil
State of the art of first trimester
pre-eclampsia screening
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Why am I here?
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- Identifying women at high risk in the first trimester allows preventive
actions such as low-dose aspirin intake starting before 16 weeks
- However, the number of women attending their first antenatal visit after
14 weeks is often more than 50% and can be as high as 88.5% in
developing countries
- Screening for PE in the second trimester could still be of benefit, since
close monitoring looking for early signs of PE allows timely treatment
and delivery
MUFW & SUFW
Who we are
Mid-2013
6 sites 10 sites
40,000 1st trim PE screenings
Largest dedicated O&G ultrasound practice in Australasia
~ 80,000 scans per year; 10,000 NIPT; 10,000 PE screenings
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We have a problem….
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2 - 8% of the pregnancies
6.6 million cases per year worldwide
US - 18% of maternal deaths
1 maternal death caused by PE every 12 minutes
15% of premature deliveries
Future cardiovascular risk
Pre-eclampsia
Background
Duley L. The global impact of pre-eclampsia and eclampsia. Semin Perinatol 2009; 33: 130-137.
Wu P et al. Circ Cardiovasc Qual Outcomes 2017; 10.
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Mortality
Morbidity
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How are we addressing
this problem?
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Ministry of Health Report. 1929
Memorandum on antenatal clinics: their
conduct and scope. His Majesty’s Stationery
Office, London; 1930.
The Fetal Medicine
FoundationJAMA April 25, 2017 Volume 317, Number 16
The Fetal Medicine
Foundation Obstetricians in action…
The Fetal Medicine
FoundationClinical Chemistry 58:5 837–845 (2012)
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Screening strategies
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High risk factors
Hypertensive disease in a previous pregnancy
Chronic renal disease
Chronic hypertension
Diabetes mellitus
Autoimmune disease such as SLE or APS
Moderate risk factors
First pregnancy
Age > 40 years
Body mass index > 35 kg/m2
Inter-pregnancy interval > 10 years
Family history of preeclampsia
NICE guidelines 2010
High-risk in need of aspirin
Preeclampsia in >2 previous pregnancies
Preeclampsia <34w in previous pregnancy
Task Force on Hypertension in Pregnancy
ACOG 2013
Risk factors
Preeclampsia in a previous pregnancy
Chronic renal disease
Chronic hypertension
Diabetes mellitus
SLE or thrombophilia
First pregnancy
Age > 40 years
Body mass index > 30 kg/m2
Conception by in vitro fertilization
Family history of preeclampsia
Prediction of pre-eclampsia
Guidelines
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Tan MY et al. Comparison of diagnostic accuracy of early screening for pre-eclampsia by NICE guidelines and a method combining
maternal factors and biomarkers: results of SPREE. Ultrasound Obstet Gynecol 2018, DOI 10.1002/uog.19039.
23%
High-risk x prevention – Nice, UK
0
10
20
30
40
50
60
80
90
100
70
Dete
cti
on
ra
te (
%)
<37w >37w Total
FP 10.2%
41%
26%30%
Prediction of pre-eclampsia
SPREE study, n=16,747
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10 %
High-risk x prevention
Prediction of pre-eclampsia
History-based screening
Ortved D, Hawkins TL, Johnson JA, et al. The cost-effectiveness of first trimester
screening and early preventative use of aspirin in women at high risk of early
onset pre-eclampsia. Ultrasound Obstet Gynecol 2018
24%
Australia – SOMANZ guidelines Canada – SOGC guidelines
Helou A et al. Management of pregnancies complicated by hypertensive
disorders of pregnancy: Could we do better? Aust N Z J Obstet Gynaecol
2017
The Fetal Medicine
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The new approach
The Fetal Medicine
FoundationDisease Models & Mechanisms 2012 5: 9-18
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Early-onset PE is the worst
spectrum of the disease!
PRE-ECLAMPSIA
TWO DIFFERENT
SPECTRUM
PRETERM
DELIVERY < 37 WEEKS
TERM
DELIVERY > 37 WEEKS
30% OF CASES
80% 0F
COMPLICATIONS
70% OF CASES
20% OF
COMPLICATIONS
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Prevention of pre-eclampsia
Mechanism of disease
But is it really the placenta ? Or is it all about the heart ?
- Poor placentation
- Damage to endothelium and cardiovascular
system are secondary
- Aspirin is anti-inflammatory
- Bad heart
- Failure to reach fetal and placental demands
- Parallel with GDM, resolves with delivery
- Aspirin for prevention of cardiovascular disease
+
Preterm PE Term PE
37 weeks
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Determine prior risk:• Maternal characteristics• Medical / obstetric history
Estimate posterior risk
• Measure biomarkers• Express as MoMs• Modify prior risk
Prediction of pre-eclampsia
New approach
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Effect on time to delivery with PE (w)
-8 -7 -6 -5 -4 -3 -2 -1 0 1 2 3 4
Chronic Hypertension
Race Black
South Asian
SLE / APS
Family history of PE
Diabetes mellitus
Conception by IVF
Age 35 y
40 y
45 y
Weight 50 kg
70 kg
90 kg
110 kg
Wright D et al. Competing risks model in screening for preeclampsia by
maternal characteristics and medical history. Am J Obstet Gynecol 2015
Low risk
24 28 32 36 40 44 48 52 56 60 64 68 72 76 80
Gestational age at delivery with preeclampsia (w)
High risk
1%
30%
2-3%
24 28 32 36 40 44 48 52 56 60 64 68 72 76 80
Average risk
Prediction of pre-eclampsia
Maternal characteristics, n=120,492
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Gestational age (w)
24 28 32 36 40 44
0.05
0.1
0.2
0.30.40.5
1.0
1.52.0
3.44.45.0
Gestational age (w)
24 28 32 36 40 44
0.05
0.10.1
0.2
0.3
0.40.5
1.0
1.5
2.0
3.0
4.0
Gestational age (w)
24 28 32 36 40 44
0.7
0.8
0.9
1
1.1
1.2
1.3
1.4
1.5
1.6
0.3
0.4
0.5
0.6
0.8
1.0
1.5
2.0
2.5
3.03.54.0
Gestational age (w)
24 28 32 36 40 44
PLGF (MoM)PAPP-A (MoM)MAP (MoM)UTPI (MoM)
O’ Gorman N et al. Competing risks model in screening for preeclampsia by maternal factors and biomarkers at 11-13 weeks’ gestation. Am J Obstet Gynecol 2016
FPR 10%
Prediction of pre-eclampsia
Biomarkers, n=33,840
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• Age: every 10 years above 30 y• Weight: every 10 kg above 70 kg
• Racial origin Afro-CaribbeanSouth Asian
• Obstetric history First pregnancy
• Family history of preeclampsia
• Autoimmune : SLE / APS
• Chronic hypertension• Diabetes mellitus
Previous preeclampsia
• Conception by IVF
Maternal risk factors
Wright D et al. Competing risks model in screening for preeclampsia by maternal characteristics and medical
history. Am J Obstet Gynecol 2016;
O’Gorman N et al. Competing risks model in screening for preeclampsia by maternal factors and biomarkers
at 11-13 weeks’ gestation. Am J Obstet Gynecol 2016; 214: 103
0
10
20
30
40
50
60
80
90
100
70
PE <32w
De
tec
tio
n
rate
(%
)
FPR 10%
PE <37w PE >37w
History, MAP, UT PI, PLGF
75%
89%
47%
Prediction of pre-eclampsia
FMF algorithm – Bayes theorem
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High risk factors
Hypertensive disease in a previous pregnancy
Chronic renal disease
Chronic hypertension
Diabetes mellitus
Autoimmune disease such as SLE or APS
Moderate risk factors
First pregnancy
Age > 40 years
Body mass index > 35 kg/m2
Inter-pregnancy interval > 10 years
Family history of preeclampsia
NICE guidelines 2010
0
10
20
30
40
50
60
80
90
100
70
PE <37w
De
tec
tio
n ra
te (
%)
FMF: FPR 10.0%
NICE: FPR 10.3%
ACOG: FPR 0.2%
PE >37w
39%34%
75%
45%
ACOG 2013: High-risk in need of aspirin
Preeclampsia in >2 previous pregnancies
Preeclampsia <34w in previous pregnancy
5%2%
Prediction of preeclampsia
ASPRE screening validation
O'Gorman N et al. Multicenter screening for pre-eclampsia by maternal factors and biomarkers at
11-13 weeks' gestation: comparison with NICE guidelines and ACOG recommendations.
Ultrasound Obstet Gynecol 2017.
O'Gorman N et al. Accuracy of competing-risks model in screening for pre-eclampsia by maternal
factors and biomarkers at 11-13 weeks' gestation. Ultrasound Obstet Gynecol 2017.
Prediction of pre-eclampsia
ASPRE screening study, n=8,775
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PE 239 (2.7%)
8,775 underwent screening
No PE 8,536 (97.3%)
Virgen de la Arrixaca, Murcia, Spain
San Cecilio Hospital, Granada, Spain
Hospiten Sur, Tenerife, Spain
Chu Brugmann Brussels, Belgium
Attikon University Hospital, Greece
Ospedale Maggiore Policlinico, Italy
Rabin Medical Center, Israel
King’s College Hospital, UK
Medway Maritime Hospital, UK
Lewisham University Hospital, UK
North Middlesex Hospital, UK
Southend University Hospital, UK
Homerton University Hospital, UK
Statistical analysis: D Wright, A Wright PE <34 wD
ete
cti
on
rate
(%
)20
30
40
50
60
70
80
90
100
PE <37 w PE >37 w
Prediction of pre-eclampsia
ASPRE screening validation
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PE screeningPatient
acceptability
Efficacy
Safety
Cost
The skepticism The fear of the unknown
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External validation
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Prof Jon Hyett
Sample 3066
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First trimester screening for early and late preeclampsia based on
maternal characteristics, biophysical parameters and
angiogenic factors.
Francesca Crovetto, MD; Francesc Figueras, MD; Stefania Triunfo, MD; Fatima Crispi, MD; Victor
Rodriguez-Sureda, PhD; Carmen Dominguez, PhD; Elisa Llurba, MD; Eduard Gratacos, MD.
Prenatal Diagnosis, Oct 2014
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Prediction of pre-eclampsia
SPREE study
SCREENING METHOD <34w <37w >37w
NICE 47 41 26
History 48 42 30
MAP 65 49 40
UTPI 73 63 33
PLGF 67 59 34
PAPP-A 57 46 30
PLGF, PAPP-A 70 62 35
MAP, UTPI 88 74 44
MAP, PLGF 73 69 40
MAP, PAPP-A 67 54 38
MAP, UTPI, PLGF 90 82 44
MAP, UTPI, PAPP-A 87 77 43
MAP, PLGF, PAPP-A 78 69 39
MAP, UTPI, PLGF, PAPP-A 90 82 44
0
10
20
30
40
50
60
80
90
100
70
Dete
cti
on
ra
te (
%)
<34w
47%
90%
<37w
41%
82%
>37w
26%
44%
NICE
History, MAP, UTPI, PLGF
Tan MY, et al. Submitted 2018
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It’s complicated…
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Multiparametric
approach
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Prediction of pre-eclampsia
Risk calculation
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Prediction of pre-eclampsia
Risk calculation
www.fetalmedicine.org
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Prediction of pre-eclampsia
Risk calculation
Cell phone
app
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Quality assurance
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SUFW MUFW
0.9594: 95% CI 0.9583, 0.9605
Quality assurance - MAP
0.9737 : 95% CI 0.9717 , 0.9756
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1.0311 : 95% CI 1.0275 , 1.0346
SUFW MUFWQuality assurance – UtArt PI
1.0364 : 95% CI 1.0299 , 1.0429
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Screening of preeclampsia
Our research
Uterine artery DopplerQuality assurance
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1.137 : 95% CI 1.1296 , 1.1444
SUFW MUFW
Quality assurance – PAPP-A
1.0229 : 95% CI 1.0113 , 1.0346
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0.9776 : 95% CI 0.973 , 0.9823
SUFW
Quality assurance – PlGF
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Screening of preeclampsia
SPR
SUFW
MUFW
~11%
~11%
ASPRE ~11%
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Global implementation
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J. Perinat. Med. 2017
Rocha RS, Alves JAG, Maia E Holanda Moura SB, Araujo Júnior E, Peixoto AB, Santana EFM, Martins WP, Vasconcelos CTM, Da Silva Costa F, Oriá
MOB. J Perinat Med. 2017 Oct 26;45(7):843-849.
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Rocha RS, Gurgel Alves JA, Bezerra Maia E Holanda Moura S, Araujo Júnior E, Martins WP, Vasconcelos CTM, Da Silva Costa F, Oriá MOB.
Pregnancy Hypertens. 2017 Oct;10:113-117.
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Stability of placental growth factor, soluble fms-
like tyrosine kinase 1, and soluble fms-like
tyrosine kinase 1 e15a in human serum and
plasma
S. Rowson1, M. Reddy2,3, D. L. Rolnik2,3, F. da
Silva Costa2,4, K.R. Palmer2,3.
Unpublished, 2019
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“A combination of maternal factors,
maternal arterial blood pressure, uterine
artery Doppler and PlGF level at 11–13
weeks appears to be the most efficient
screening model for identification of
women at risk of PE” (GRADE OF
RECOMMENDATION: B).
Guideline
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Prevention
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Antiplatelet agents for prevention of pre-eclampsia: a meta-analysis of individual patient data
Askie LM, Duley L, Henderson-Smart DJ, Stewart LA. Lancet 2007; 369:1791
• Meta-analysis of individual patient data from 32,217 women, recruited to 31 randomised trials of PE prevention.
Antiplatelet agents vs. Control
• Relative risk of developing preeclampsia: 0.90 (95% CI 0.84-0.97)
• Relative risk of delivery before 34 weeks: 0.90 (95% CI 0.83-0.98)
• Relative risk of serious adverse outcome: 0.90 (95% CI 0.85-0.96)
• Antiplatelet agents had no significant effect on the risk of bleeding events for either the women or their babies
Moderate reduction in risk of PE, birth <34 weeks and serious adverse outcome
Prevention of pre-eclampsia
Low-dose aspirin
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Bujold et al., 2010; Roberge et al., 2012; 2013
.2 .4 .6 .8 1 1.2 1.6 2.00
Risk ratio (95% CI)
Preterm-PE(2/283 vs 43/273)
0.11 (0.04-0.3)
Term-PE(37/283 vs 32/273)
0.98 (0.4-2.3)
In the group with aspirin at <16 w
.2 .4 .6 .8 1 1.2 1.6 2.00
< 16 w (n=1,479) 0.47 (0.36-0.62)
> 16 w (n=10,673) 0.78 (0.61-0.99)
Gestation at start of aspirin
Prevention of pre-eclampsia
Low-dose aspirin
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Screening 26,941
High-risk 2,971
Randomised n=1,776
800 Aspirin 824 Placebo
Compliance:
86% of women took >80% of tablets
95% of women took >50% of tablets
Rolnik DL et al, Aspirin versus Placebo in Pregnancies at High Risk of Preterm Preeclampsia. NEJM 2017
11%
60%
Prevention of pre-eclampsia
ASPRE trial
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24 26 28 30 32 34 36 38 40 42
Gestation at delivery (wk)
Placebo
Aspirin
5
10
15
20
25
Cu
mu
lati
ve
in
cid
en
ce
of
PE
(%
)
0
PE <34 w: 1.8% vs 0.4% 82% drop
PE <37 w: 4.3% vs 1.6% 62% drop
PE >37 w: 7.2% vs 6.6% 5% drop
0
10
20
30
40
50
60
80
90
100
70
<34w
Pre
ven
tio
n ra
te (
%)
38%
18%
<37w
95%
>37w
Prevention of pre-eclampsia
ASPRE trial
Rolnik DL et al, Aspirin versus Placebo in Pregnancies at High Risk of Preterm Preeclampsia. NEJM 2017
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Poon LC, Rolnik DL, Tan MY, et al. Ultrasound Obstet Gynecol 2018
Incidence PE < 37w (0.7%)
FMF + FMF -
NICE + (10.8%) 6.9% 0.48%
ACOG + (64.5%) 4.8% 0.25%
Previous preeclampsia 708
(2.0%)
Preeclampsia < 37 w
35 (4.9%)
FMF –
2 (0.7%)
FMF +
33 (8.0 %)
Prevention of pre-eclampsia
ASPRE study, n=34,573
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Drug trials should take into account compliance
Aspirin vs. Placebo
0.05 0.2 1 1.50.1 0.5
OR with 95% CI
Compliance
0.38; 0.20 to 0.74
>90% (71%) 0.24; 0.09 to 0.65
Any (100%)
<90% (29%) 0.59; 0.23 to 1.53
Wright D, Poon LC, Rolnik DL, et al. Am J of Obstet Gynecol 2018
Prevention of pre-eclampsia
ASPRE trial - Compliance
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Prof Jon Hyett
Ultrasound in Obstetrics and Gynecology doi: 10.1002/uog.14819
Prevention of pre-eclampsia
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How does aspirin work?
Differentiation
PE
Apoptosis
PlGF
Cytokines
Shanika Panagodage,*y Hannah E.J. Yong,*y Fabricio Da Silva Costa,*y Anthony J.
Borg,* Bill Kalionis,*yShaun P. Brennecke,*y and Padma Murthi*yz
The American Journal of Pathology, Vol. 186, No. 12, December 2016
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“There is convincing evidence that low-
dose aspirin can decrease significantly
the risk for development of early PE, when
administration commences at the time of
first-trimester screening (GRADE OF
RECOMMENDATION: A).
Guideline
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Cost-effectiveness
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24 26 28 30 32 34 36 38 40 42
Gestation at birth (w)
0
5
10
15
20
25
30
35
40
45
50
55
Cu
mu
lati
ve n
um
ber
of
all b
ab
ies a
dm
itte
d t
o N
ICU
24 26 28 30 32 34 36 38 40 42
Gestation at birth (w)
0
5
10
15
20
25
30
35
40
45
50
55
Cu
mu
lati
ve n
um
ber
of
bab
ies in
NIC
U f
or
>14 d
ays
24 26 28 30 32 34 36 38 40 42
Gestation at birth (w)
0
100
200
300
400
500
600
700
800
900
1000
1100
1200
1300
1400
1500
1600
1700
Cu
mu
lati
ve len
gth
of
sta
y in
NIC
U (
days)
Wright D, Rolnik DL, Syngelaki A, et al. Am J Obstet Gynecol 2018
Prevention of pre-eclampsia
ASPRE trial - Lenght of stay in NICU
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Ortved D, Hawkins TL, Johnson JA, et al. The cost-effectiveness of first trimester screening and early preventative use of aspirin
in women at high risk of early onset pre-eclampsia. Ultrasound Obstet Gynecol 2018
Viguiliouk E, Park AL, Berger H, et al. Low rates of aspirin use for the prevention of preeclampsia. J Obstet Gynaecol Can 2017
Combined screening
Cost-effectiveness (Canada - n=387,516)
Current practice (SOGC) Cost $23,910,467.06
Cost $9,523,485.26
The cost-effectiveness of first trimester screening and early preventative use of
aspirin in women at high risk of early onset pre-eclampsia
Ortved D, Hawkins TL, Johnson JA, Hyett J, Metcalfe A, Ultrasound Obstet Gynecol, 2018
Prevention of pre-eclampsia
Cost-effectiveness
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Effective in low risk population?
Compliance / Adherence to treatment?
Long-term safety?
Prevention of pre-eclampsia
Universal aspirin ?
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Strategy Detection Missed False positive Detected Cases avoided NNS NNT
FMF 77% 23% 10% 614 380 263 38
NICE 39% 61% 10.2% 312 193 517 55
ACOG 5% 95% 0.2% 40 25 4032 10
Universal Aspirin 100% – 99.2% - 496 No screening 202
800 PE < 37 weeks
Prevalence 0.8%
100,000 pregnancies
Prevention of pre-eclampsia
Clinical implementation
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Future perspectives
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Screening of pre-eclampsia
Our research
Chasing novel biomarkers to predict PE
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BJOG. 2018 Jun;125(7):848-855
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Fetal fraction as a marker of placentation ? – potential marker
Prevention of pre-eclampsia
New markers
Rolnik DL, da Silva Costa F, Lee TJ, et al. Association between fetal fraction on cell-free DNA testing and first trimester markers for pre-eclampsia. Ultrasound Obstet Gynecol. 2018
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The cardiovascular toll of pre-eclampsia:
determining impacts on the maternal, fetal and placental vasculature
• Markers of endothelial dysfunction: sFlt-1, sFlt-1 e15a, PlGF, ICAM-1 and VCAM-1
• Markers of cardiovascular function:
- Uterine artery Doppler
- Ophthalmic artery Doppler
- Mean arterial pressure
- Cardiac output, stroke volume, heart rate, systemic vascular resistance
- Arterial stiffness
• Markers of fetal wellbeing
• Routine biochemical markers of pre-eclampsia
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ESPRESSO trial
NSW:
Jon Hyett
NHMRC Clinical Trials
Centre / William Tarnow-
Mordi
Victoria:
Fabricio Costa
Shaun Brennecke
Stephen Tong & Susan Walker
South Australia:
Gus Dekker
Jonathan Morris
Preeclampsia prevention trial –
1st trimester screening algorithm
Esomeprazole
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Esomeprazole for prevention of PET:
Phase II RCT
Primary outcome measure:
A 3mmHg reduction in maternal Mean Arterial Pressure
at 36 weeks.
Secondary outcome measures:
A reduction in serum [sFlt-1] or [sENG] at 34-36
weeks.
An increase in duration of pregnancy.
A reduction in the proportion of women developing pre-
eclampsia or gestational hypertension.
A reduction in levels of proteinuria at 34-36 weeks.
A significant difference in birth weight (mean | 3rd, 5th
and 10th centiles).
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Validação prospectiva do screening para pre-
eclampsia no primeiro trimestre da gestacao na
população brasileira SPREBRA study
Investigadores associados:
Prof Dr Ricardo Cavalli – FMRP/USP-SP
Prof Dr Geraldo Duarte – FMRP/USP-SP
Profa Dra Alessandra Marcolin – FMRP/USP-SP
Profa Dra Silvana Quintana – FMRP/USP-SP
Profa Dra Elaine Moisés – FMRP/USP-SP
Prof Dr Marcelo Zugaib – FMUSP-SP
Profa Dra Rossana Francisco – FMUSP-SP
Prof Dr Guilherme Lobo – UNIFESP-SP
Profa Dra Vera Borges – UNESP-SP
Profa Dra Denise Vaz Oliani – FAMERP-SP
Prof Dr Renato Sá – FIOCRUZ-RJ
Profa Dra Sammya Bezerra – UNIFOR-CE
Prof Dr Eduardo Fonseca – Universidade Federal da Paraíba-PB
Profa Dra Mônica Oriá – UFC-CE
Prof Dr Edson da Cunha Filho – PUC-RS
Dr Michael de Mello Constantino – FMPR-USP
Dr Daniel Rolnik – Monash University (Australia)
Investigador principal:
Prof Dr Fabricio da Silva Costa
Instituicao:
Departamento de Ginecologia e Obstetricia,
Faculdade de Medicina de Ribeirao Preto,
Universidade de São Paulo
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What we do…
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Screening of preeclampsia
Our NEW model
NIPT+
1st trim morphology scan
10-11 w
12-13 w
NT
Maternal factors
MAP
UtArt PI
NIPT bloods β-hcg, PAPP-A, PlGF
FTCS β-hcg, PAPP-A, PlGF
US
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Prediction of pre-eclampsia
Take home messages
Current strategy using only maternal history is not effective
There is a strong body of evidence supporting combined screening
At least combination of maternal history and MAP. Full screening is ideal
(UtA and PlGF)
ISUOG guideline supports combined screening. FIGO guideline coming
soon
Aspirin prevents PE effectively in a truly high risk group
It’s time for clinical implementation!
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Thank you!