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Study on Aspirin for Preventing Preeclampsia in First-Time Pregnant Women Using Assisted Reproductive Technology

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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 investigating the use of acetylsalicylic acid, commonly known as aspirin, as a preventive treatment. Aspirin is being tested in a daily dose of 150 milligrams, taken orally in the form of a hard capsule. The trial aims to determine if aspirin can help prevent preterm preeclampsia, which is when the condition develops before 37 weeks of pregnancy, in women who are pregnant for the first time after using assisted reproductive technology, such as in vitro fertilization.

The purpose of the study is to evaluate the effect of aspirin compared to a placebo in preventing preterm preeclampsia. Participants will begin taking the medication between 9 and 14 weeks of pregnancy and continue until the 26th week. Throughout the study, various outcomes will be monitored, including the occurrence of preeclampsia, preterm birth, cesarean delivery, and other pregnancy-related complications. The study will also track the health of the newborn, including birth weight and any complications that may arise after birth.

Participants will be asked to adhere to the treatment regimen, and their adherence will be monitored by counting the pills at each visit and using a diary or application. The study will also consider the cost-effectiveness of the treatment, looking at the costs associated with hospitalizations, consultations, and other medical expenses. The trial is expected to conclude by the end of 2026, with recruitment having started in early 2023.

The research process

The trial runs in 6 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, you will be asked to provide written informed consent. This means you agree to participate after understanding the trial's purpose and procedures.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying that you are a nulliparous woman aged 18 or older, with a pregnancy following assisted reproductive technology, and between 9 and 14 weeks of gestation.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either aspirin or a placebo. The aspirin dosage is 150 mg, taken orally once daily. This will continue from the time of assignment until the end of the trial.

  4. Step 4

    Regular check-ups

    Regular check-ups will be scheduled to monitor your health and the progress of your pregnancy. These visits will include assessments of your adherence to the treatment, which involves counting the pills and possibly using a diary or application.

  5. Step 5

    Monitoring and recording

    Throughout the trial, occurrences of any health events will be recorded. This includes any symptoms or side effects such as bleeding, headache, nausea, skin rash, or abdominal pain.

  6. Step 6

    End of trial

    The trial will conclude after delivery, and a final assessment will be conducted. This will include a review of your health and the baby's health, as well as any resources used during the trial.

Who can join the trial?

6 criteria

  • Nulliparous women aged 18 years or more. (Nulliparous means women who have never given birth to a child.)
  • Pregnancy following ART, including in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), oocyte donation, or intrauterine insemination with sperm donor. (ART stands for Assisted Reproductive Technology, which helps people become pregnant.)
  • Singleton pregnancy. (This means being pregnant with only one baby.)
  • Evolutive pregnancy between 9 and 14 weeks of gestation. (Gestation refers to the period of pregnancy, and evolutive means the pregnancy is progressing normally.)
  • Women affiliated to a French Social Security Insurance or equivalent social protection. (This means having health insurance or similar coverage.)
  • Written informed consent. (This means agreeing to participate in the study after being fully informed about it.)

Who cannot join the trial?

7 criteria

  • Women who are not pregnant cannot participate.
  • Women who are not in their first pregnancy (nulliparous) cannot participate.
  • Women who did not use assisted reproductive technology to become pregnant cannot participate.
  • Women who are not between 9 and 14 weeks of pregnancy cannot participate.
  • Women who are not at risk of developing preeclampsia cannot participate. Preeclampsia is a condition that can occur during pregnancy, characterized by high blood pressure and signs of damage to other organs.
  • Women who are not willing to take aspirin or a placebo daily cannot participate. A placebo is a harmless pill with no active medication, used in studies to compare effects.
  • Men cannot participate in this study.
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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 used to help prevent a condition called preeclampsia, which can occur during pregnancy. Preeclampsia is a serious condition that can affect both the mother and the baby, leading to high blood pressure and potential complications. The trial is testing whether taking aspirin daily during early pregnancy can lower the risk of developing preeclampsia in women who are pregnant for the first time after using assisted reproductive technology.

What is already known about the treatment

Aspirin – Aspirin is taken orally in the form of a tablet and is currently being studied for its potential to prevent preeclampsia, a condition that can occur during pregnancy. In medical literature, aspirin is well-known for its use in reducing pain, fever, and inflammation, and it is being explored for new uses in pregnancy-related conditions. The main therapeutic indication in this trial is to prevent preterm preeclampsia in first-time pregnant women who have undergone assisted reproductive technology. At the molecular level, aspirin works by inhibiting certain enzymes that lead to inflammation and blood clotting, which may help improve blood flow to the placenta. It is classified as a nonsteroidal anti-inflammatory drug (NSAID).

Investigated diseases

Preeclampsia – Preeclampsia is a condition that occurs during pregnancy, characterized by high blood pressure and often a significant amount of protein in the urine. It typically develops after 20 weeks of gestation in women whose blood pressure had previously been normal. The condition can lead to complications for both the mother and the baby if not monitored. Preeclampsia can cause damage to various organs, most commonly the liver and kidneys. Symptoms may include severe headaches, changes in vision, upper abdominal pain, and swelling in the hands and face. The progression of preeclampsia can vary, and it requires careful management to prevent further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-500933-10-00Protocol codeRC31/21/0337Estimated enrolment1 164 patientsSponsorCentre Hospitalier Universitaire De Toulouse

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