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Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicentre, randomised, double-blind, placebo-controlled trial (ASPRE-T)
EU CTIS ID: 2023-503698-40-00
What this study is testing
To determine the effect of low-dose aspirin on theincidence of preterm preeclampsiawith delivery <37 weeks’ gestation.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 18 years.
- DCDA or MCDA twin pregnancies.
- Both live fetuses at 11+2-13+6 weeks of gestation.
- Informed and written consent.
You likely can't join if
- Monoamniotic twins.
- Patients who are suffering from known gout, severe hepatic impairment or severe renal impairment.
- Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, rhinitis and urticaria) or to any excipients (see section 6.1 of the SmPC for details).
- Patients on long term non-steroidal anti-inflammatory medication.
- Not fluent in local language and absence of interpreter.
- Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
See the full eligibility criteria
- Age > 18 years.
- DCDA or MCDA twin pregnancies.
- Both live fetuses at 11+2-13+6 weeks of gestation.
- Informed and written consent.
- Monoamniotic twins.
- Patients who are suffering from known gout, severe hepatic impairment or severe renal impairment.
- Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, rhinitis and urticaria) or to any excipients (see section 6.1 of the SmPC for details).
- Patients on long term non-steroidal anti-inflammatory medication.
- Not fluent in local language and absence of interpreter.
- Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
- Triplet pregnancies that had undergone embryo reduction to twins or with one vanishing twin.
- Pregnancies complicated by major fetal abnormality or nuchal translucency thickness >3.5 mm identified at the 11+2-13+6 weeks scan.
- MCDA twin pregnancies in which there are early signs of TTTS or sFGR defined by a 20% discordance in CRL at the 11+2-13+6 weeks’ scan.
- Those who lack capacity and who are unable to provide informed consent to take part.
- Women taking low-dose aspirin regularly (administration must have ceased >7 days prior to randomization).
- Participation in another drug trial within the previous 7 days.
- Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia or concurrent anticoagulant therapy.
- Active or history of recurrent peptic ulceration and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- Australia
- Israel
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; Australia; Israel; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.