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Study on Aspirin for Preventing Preeclampsia in Twin Pregnancies

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying preeclampsia, a condition that can occur during pregnancy, characterized by high blood pressure and potential damage to other organs, often the liver and kidneys. The study is specifically looking at twin pregnancies. The treatment being tested is Aspirin 75mg Gastro-resistant Tablets, which contains the active ingredient acetylsalicylic acid. This medication is being compared to a placebo to see if it can help prevent preeclampsia in women expecting twins.

The purpose of the study is to determine if taking a low dose of aspirin can reduce the chances of developing preeclampsia before 37 weeks of pregnancy. Participants in the study will be randomly assigned to receive either the aspirin or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the aspirin and who is receiving the placebo, to ensure unbiased results.

Throughout the study, participants will take the assigned tablets orally. The trial will monitor the health of the participants and their pregnancies to assess the effectiveness of aspirin in preventing preeclampsia. The study aims to provide valuable information on whether aspirin can be a helpful preventive treatment for preeclampsia in twin pregnancies.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, participants will be randomly assigned to one of two groups. One group will receive aspirin 75mg gastro-resistant tablets, and the other group will receive a placebo. A placebo is a tablet that looks like the real medication but does not contain the active ingredient.

    The trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the aspirin or the placebo. This helps ensure the results are unbiased.

  2. Step 2

    Medication administration

    Participants will take one aspirin 75mg gastro-resistant tablet or one placebo tablet orally every day. The term 'orally' means the tablet is swallowed through the mouth.

    The medication will be taken from the first trimester of pregnancy until delivery, which is before 37 weeks of gestation. This is to assess the effect of low-dose aspirin on reducing the incidence of preterm preeclampsia, a condition that can occur during pregnancy.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, participants will have regular check-ups to monitor their health and the progress of the pregnancy. These check-ups are important to ensure the safety of both the participant and the fetuses.

    Participants will be asked to report any side effects or unusual symptoms they experience during the trial. This information is crucial for assessing the safety and effectiveness of the treatment.

  4. Step 4

    Completion of the trial

    The trial is expected to end by January 30, 2026. At the end of the trial, the data collected will be analyzed to determine the effectiveness of low-dose aspirin in preventing preterm preeclampsia in twin pregnancies.

    Participants will be informed about the results of the trial and any relevant findings that may affect their health or future pregnancies.

Who can join the trial?

4 criteria

  • Must be over 18 years old.
  • Must be pregnant with twins. This can be either DCDA (dichorionic diamniotic) or MCDA (monochorionic diamniotic) twins. These terms refer to the type of twin pregnancy based on the number of placentas and amniotic sacs.
  • Both babies must be alive between 11 weeks and 2 days to 13 weeks and 6 days of pregnancy.
  • Must provide informed and written consent, meaning you understand the study and agree to participate in writing.

Who cannot join the trial?

3 criteria

  • Patients who are not female cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are not considered part of the vulnerable population cannot participate.
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Investigated drugs

Aspirin is a medication commonly used to relieve pain, reduce inflammation, and lower fever. In this clinical trial, it is being tested to see if it can help prevent a condition called preeclampsia in women who are pregnant with twins. Preeclampsia is a serious condition that can occur during pregnancy, leading to high blood pressure and other complications. The trial aims to find out if taking a low dose of aspirin can reduce the chances of developing preeclampsia before 37 weeks of pregnancy.

What is already known about the treatment

Aspirin – Aspirin is taken orally, usually in the form of a tablet, and is currently being studied for its potential to prevent preeclampsia in twin pregnancies. In medical literature, it is recognized for its role in reducing inflammation and preventing blood clots. The main therapeutic indication in this trial is to lower the risk of preterm preeclampsia, a condition that can occur during pregnancy. At the molecular level, aspirin works by inhibiting an enzyme called cyclooxygenase, which reduces the production of substances that promote inflammation and clotting. It is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Investigated diseases

Preeclampsia – Preeclampsia is a pregnancy-related condition characterized by high blood pressure and often protein in the urine. It typically occurs after the 20th week of pregnancy. The condition can lead to complications for both the mother and the baby if not monitored. Symptoms may include swelling, sudden weight gain, headaches, and changes in vision. The exact cause of preeclampsia is not fully understood, but it is believed to involve problems with the blood vessels in the placenta. The condition can progress to more severe forms, affecting various organs and leading to further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503698-40-00Protocol codeFFIS/2019/01/ASEstimated enrolment1 925 patientsSponsorFundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

sourced from the EU Clinical Trials Register and site verification

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