Aspirin versus placebo in twin pregnancies for preeclampsia prevention
Research type
Research Study
Full title
Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicenter, randomised, double-blind, placebo-controlled trial (ASPRE-T)
IRAS ID
269958
Contact name
Kypros Nicolaides
Contact email
Sponsor organisation
Fundación para la Formación e Investigación Sanitaria
Eudract number
2019-003341-15
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 11 months, 29 days
Research summary
There has recently been a large scale randomised controledl trial showing the significance of aspirin therapy administered at an early gestation for the prevention of preeclampsia (PE) in singletons (Rolnik et al 2017). However, the evidence in twins has not been established. It is generally accepted that twin pregnancies are associated with higher incidences of PE given the increased amount of placental tissue, but also due to the increased proportion of conceptions through assisted reproductive techniques, which in itself is also a risk factor for PE. One strategy would be to treat all these women as high risk and generically administer aspirin, but the evidence shows that this would not be without risk, with one study showing an increase in the numbers of placental abruptions for those taking aspirin therapy (Yu et al 2003).
It is of critical importance that we aim to effectively target those who are at risk, as twin pregnancies are already at increased risk of preterm delivery, and lowering PE, would go someway to reducing the iatrogenic rate of preterm birth. Furthermore, there remains considerable debate on the correct dosing of aspirin. There is existing evidence that using 75mg aspirin is met with aspirin resistance in up to 10% of the population, hence the dosage to be investigated in this trial, is the higher 150mg that has been proven to show efficacy in the most recent RCT in singletons (Rolnik et al., 2017).
This study aims to randomise women with twin pregnancies, to aspirin 150mg or placebo, to address its efficacy in a population at increased risk of PE.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0757
Date of REC Opinion
12 Apr 2022
REC opinion
Further Information Favourable Opinion