Study on Low Dose Acetylsalicylic Acid to Prevent Preeclampsia in Pregnant Women After Frozen Embryo Transfer

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What is this study about?

This clinical trial is focused on studying the condition known as preeclampsia, which can occur during pregnancy and is characterized by high blood pressure and potential damage to other organs, often the liver and kidneys. The study is investigating the use of a medication called acetylsalicylic acid, commonly known as aspirin, in a low dose of 160 mg. This medication is being tested as a preventive treatment for preeclampsia in pregnant women who have undergone a procedure called frozen embryo transfer, which is a part of some fertility treatments.

The purpose of the study is to determine if taking low-dose acetylsalicylic acid can reduce the occurrence of preeclampsia in these women. Participants in the study will be randomly assigned to either receive the medication or not receive any treatment, which is known as a placebo group. The study will monitor the health of the participants throughout their pregnancy to see how many women in each group develop preeclampsia.

The study will take place over a period of time, with participants being followed from the early stages of their pregnancy. The goal is to gather enough information to understand whether the use of acetylsalicylic acid can effectively prevent preeclampsia in women who have had a frozen embryo transfer. This research could potentially lead to new guidelines for preventing this condition in similar cases in the future.

1 joining the study

Participation begins after confirming pregnancy at week 6 of amenorrhea following a frozen embryo transfer.

Eligibility includes being a healthy woman aged 18 to 43, having planned a frozen embryo transfer, and having given informed consent.

2 randomization

Participants are randomly assigned to one of two groups: one group receives treatment, and the other does not.

3 treatment administration

The treatment group receives acetylsalicylic acid (ASA), commonly known as aspirin, in a dosage of 160 mg.

The medication is administered orally in the form of a gastro-resistant tablet to prevent stomach irritation.

4 treatment duration

The treatment continues throughout the pregnancy, with the aim of preventing preeclampsia.

5 monitoring and follow-up

Participants are monitored for the development of preeclampsia, a condition characterized by high blood pressure during pregnancy.

The primary goal is to compare the number of women who develop preeclampsia in the treated group versus the untreated group.

6 completion of the study

The study is expected to conclude by October 1, 2025.

Results will focus on the effectiveness of low-dose ASA in preventing preeclampsia.

Who Can Join the Study?

Healthy women aged between 18 and 43 years old.
Women who are planning to have a frozen embryo transfer. This is a process where an embryo that was previously frozen is placed into the uterus.
Women who are using a natural cycle, modified natural cycle, or HRT cycle for the embryo transfer. A natural cycle means the body is not given any medication to prepare for the embryo transfer. A modified natural cycle involves minimal medication, and an HRT cycle uses hormone replacement therapy to prepare the body.
Women who have given their informed consent. This means they have been informed about the study and agree to participate.
Women who have a confirmed pregnancy at week 6 of amenorrhea. Amenorrhea means the absence of menstruation, and in this context, it refers to being 6 weeks pregnant.

Who Cannot Join the Study?

Women who are not planning to undergo a frozen embryo transfer.
Women who are not in the age range specified for the study.
Women who are not willing to take the study medication, which is 160mg of ASA (a type of aspirin).
Women who have any medical condition that the study doctors think might make it unsafe for them to participate.
Women who are already taking medications that might interfere with the study treatment.
Women who are pregnant or planning to become pregnant during the study period.
Women who have a history of allergic reactions to aspirin or similar medications.
Women who have a bleeding disorder, which means their blood does not clot properly.
Women who have severe liver or kidney disease, which means their liver or kidneys are not working well.
Women who are participating in another clinical trial at the same time.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Chirec	Brussels	Belgium
Csnkzodrz Umbwznoopjgcnr Sutowldfq	Woluwe-Saint-Lambert	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.10.2022

Trial locations

Investigated drugs:

Acetylsalicylic Acid

Acetylsalicylic Acid (ASA) is being studied in this trial as a preventive treatment for preeclampsia in pregnant women who have undergone frozen embryo transfer. The trial aims to see if taking ASA can reduce the incidence of preeclampsia, a condition characterized by high blood pressure and potential damage to other organ systems, most often the liver and kidneys, during pregnancy.

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 the 20th week of pregnancy and can affect various organs, including the liver and kidneys. Symptoms may include swelling in the hands and face, sudden weight gain, and severe headaches. The exact cause of preeclampsia is not fully understood, but it is believed to involve problems with the blood vessels that supply the placenta. If left unmanaged, it can lead to serious complications for both the mother and the baby. The condition usually resolves after the baby is delivered.

Trial ID:

2024-516816-72-00

NCT ID:

NCT05460416

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Low Dose Acetylsalicylic Acid to Prevent Preeclampsia in Pregnant Women After Frozen Embryo Transfer

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