ASPRE study signals a new era in pre-eclampsia management

The multinational ASPRE team has successfully shown that the use of aspirin dramatically reduces the risk of pre-eclampsia in pregnant women if the optimal dosage of aspirin is administered during the first trimester of pregnancy. A significant 62% reduction in rate of preterm pre-eclampsia among women who would otherwise develop the condition is great news for doctors and families. PerkinElmer is proud to have been chosen as a partner for this ground breaking study with our second generation PlGF 1-2-3™ assay.


More than 30,000 pregnancies in 6 countries

ASPRE was the biggest prospective, randomized, placebo controlled trial ever on the prophylactic use of aspirin in women at increased risk of pre-eclampsia.

Funded by the EU and administered by Professor Kypros Nicolaides and Professor Liona Poon, ASPRE recruited more than 30,000 pregnancies in the UK, Belgium, Italy, Spain, Greece and Israel.


Methodology matters

ASPRE establishes the importance of early screening in pre-eclampsia management and the efficacy of aspirin in the prevention of this major hypertensive pregnancy disorder. The cornerstone of this new screening protocol is the placental growth factor (PlGF) found in the mother’s blood. The PerkinElmer high sensitivity PlGF 1-2-3™ assay which is optimized for 1st trimester prediction, was used in the study to identify women at high risk of developing pre-eclampsia. These women were treated with an optimal 150 mg of daily aspirin after screening positive for increased risk of pre-eclampsia. They were also advised to continue taking aspirin until a few weeks before delivery. 


First trimester is key

The traditional approach to pre-eclampsia screening has relied on maternal history. Pre-eclampsia treatment has also focused on second and third trimesters, with caregivers often waiting for the disorder to develop before intervening. ASPRE study has now given definitive evidence that the best way to prevent pre-eclampsia is through early prediction and intervention. The key factor in this new screening protocol is PlGF 1-2-3 ™ – high sensitivity assay for first trimester screening.  


First trimester is key

Old protocol vs. new protocol

Current, old screening models based on maternal factors, and the new combined pre-eclampsia screening approach.

Detection rate (%)
  • 100
  • 90
  • 80
  • 70
  • 60
  • 50
  • 40
  • 30
  • 20
  • 10
  • 0
ACOG (5%): FPR 0.2%
NICE (39%): FPR 10.3%
Combined (75%): FPR 10.0%

The results are in – ASPRE is a success

Pre-eclampsia often leads to premature delivery of the fetus and sometimes to fully developed eclampsia, which is the onset of convulsions in a woman with pre-eclampsia. In both cases, the mother and her baby are at increased risk of serious health complications.

The ASPRE study showed that the use of aspirin can reduce the rate of early onset pre-eclampsia by 82%. The risk reduction in preterm-pre-eclampsia, which was the primary target group of the study, was 62%. While aspirin treatment is not a cure for pre-eclampsia, it does mean that fewer women need to suffer from this serious condition. 


ASPRE results, 82% drop in the rate of early pre-eclampsia and 62% drop in the rate of preterm pre-eclampsia

ASPRE Questions & Answers

Why can’t we just offer aspirin to all women? Why do we need to implement a screening test?


If aspirin is effective and ‘safe’ it should be given to those that would benefit from it the most. As Prof. Zarco Alfirevic commented on the NEJM website “a word of caution to all enthusiasts out there who will now start to advocate (near) universal prescribing of low dose aspirin in pregnancy. The FMF algorithm has identified an interesting phenotype which appears to respond to aspirin very well. We cannot and should not assume that all screen negative women will respond equally well to aspirin. Furthermore, current safety data are reassuring but still limited.“

The ASPRE screening algorithm, for the same screen positive rate as per NICE (The National Institute for Health and Care Excellence), identifies 75% of cases of pre-term pre-eclampsia. 

It identifies a group of at risk women that responds to aspirin in the prevention of pre-term pre-eclampsia.

In addition, we should consider the issue of compliance. A study (McNulty et al, 2011) found that compliance with Folic acid supplementation was only 19% and led to the recommendation of fortification of food in many countries.[3]

Though aspirin is considered safe in drug trials, nonetheless, it is a drug with known side effects, and therefore high risk women for pre-term pre-eclampsia should be identified and compliance with aspirin prophylaxis should be ensured throughout pregnancy.

This is an indication of the level of compliance that can be expected in a motivated high-risk group of women, who are being actively managed by their physicians. Adherence according to trial group is presented in Table 2.

adherence

Furthermore, if universal aspirin prophylaxis is to be implemented, in a screened population of 10,000 women, you would give aspirin to 10,000 women to prevent 33 cases of pre-term pre-eclampsia. This means you would give aspirin to more than 9,000 women unnecessarily.


What happens if a woman has had pre-eclampsia previously, but now elects to be screened. What if her screening procedure indicates “low risk”, but her previous history indicates she is at high risk. How would that patient be managed?


In essence the question is, what happens if the woman is screened positive by NICE guidelines, but screened negative by the FMF algorithm. We would manage her as a low risk case as a detail review of her biomarkers would indicate that they are normal. However, if the clinician feels strongly for aspirin prophylaxis, there is no harm in treating this woman with aspirin.


What if UTPI (uterine artery Doppler) is not available, are prior history, serum biochemistry and MAP (mean arterial pressure) enough?


To achieve the best prediction and prevention of pre-term pre-eclampsia (<37wks), ideally screening should be done with evaluation of maternal history, measurement of uterine artery Doppler, mean arterial pressure and placental growth factor. In the absence of one or two of the biomarker(s), risk calculation can still be done but the detection rate for pre-term preeclampsia will be reduced, in turn leading to a reduction in the treatment effect size by the aspirin prophylaxis.


What if patient presents at 14 weeks. Is there anything a physician can do concerning screening?


The algorithm has been validated for the 11–13+6 weeks gestation. 

As a minimum a clinician could still use the NICE recommendation: if a woman is at high risk, she should be started on aspirin 150 mg/day.



Webinar with Professor Kypros Nicolaides


Nicolaides_WebcastQA_BKT

First Trimester Prediction and Prevention of Pre-term Pre-eclampsia

A transcript of Professor Kypros Nicolaides webcast, broadcasted April 24th 2018.

Download the transcript (PDF)


The views and opinions expressed herein are those of the presenters and do not necessarily reflect the views of PerkinElmer. The content is provided solely for informational purposes and does not constitute medical advice or intended to be used as healthcare recommendations.
PerkinElmer PlGF 1-2-3 assay

The logical choice

PerkinElmer’s high-sensitivity PlGF 1-2-3™ assay kit is the only assay used to deliver the outcomes achieved in the ground-breaking ASPRE trial. It makes PlGF 1-2-3 the logical choice in the new era of improved pre-eclampsia management. Same high performance assay is applicable in 1st 2nd and 3rd trimesters of pregnancy to cover the every stage from early screening, reassessment and monitoring to aid in diagnosis.


Learn more about combined pre-eclampsia screening
Products may not be licensed in accordance with their laws in all countries, such as the United States and Canada. Please check with your local representative for availability.

PerkinElmer does not endorse or make recommendations with respect to research, medication, or treatments. All information presented is for informational purposes only and is not intended as medical advice. For country specific recommendations please consult your local health care professionals.
This website stores cookies on your computer. These cookies are used to improve our website and provide more personalised services to you.
Close

Cookies

To make this site work properly, we sometimes place small data files called cookies on your device. Most big websites do this too.

1. What are cookies?

A cookie is a small text file that a website saves on your computer or mobile device when you visit the site. It enables the website to remember your actions and preferences (such as login, language, font size and other display preferences) over a period of time, so you don’t have to keep re-entering them whenever you come back to the site or browse from one page to another.

2. How do we use cookies?

A number of our pages use cookies to remember your actions and preferences (such as login, language, font size and other display preferences.)

Also, some videos embedded in our pages use a cookie to anonymously gather statistics on how you got there and what videos you visited.

Enabling these cookies is not strictly necessary for the website to work but it will provide you with a better browsing experience. You can delete or block these cookies, but if you do that some features of this site may not work as intended.

The cookie-related information is not used to identify you personally and the pattern data is fully under our control. These cookies are not used for any purpose other than those described here.

3. How to control cookies

You can control and/or delete cookies as you wish – for details, see aboutcookies.org. You can delete all cookies that are already on your computer and you can set most browsers to prevent them from being placed. If you do this, however, you may have to manually adjust some preferences every time you visit a site and some services and functionalities may not work.

Close