Study on Aspirin for Preventing Preeclampsia in Twin Pregnancies

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Hospital Universitario De Cruces	Barakaldo	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Hippokration Hospital	Athens	Greece
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Alexandra Hospital	Athens	Greece
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Rigshospitalet	Copenhagen	Denmark
Hospital Universitario De Canarias	La Laguna	Spain
Hospital Quironsalud Malaga	Malaga	Spain
Medical center Oscar Clinic OOD	Sofia	Bulgaria
Sqvudkvzqst Oqoqodnbzh Aaj Gkosgjfzgg Holrmwzw Fgn Aiyibi Taopjfmif Dlz Spppqjo Evjp	Sofia	Bulgaria
Apwdqgg Hpzxccpe	Athens	Greece
Hytdfzet Vila dwroctbn	Barcelona	Spain
Heiinbui Udiupwzrwjjte dh A Ckrago	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	16.12.2022
Belgium	Recruiting	16.12.2022
Bulgaria	Recruiting	16.12.2022
Czechia	Recruiting	16.12.2022
Denmark	Recruiting	16.12.2022
Germany	Not yet recruiting	16.12.2022
Greece	Recruiting	16.12.2022
Poland	Not yet recruiting	16.12.2022
Spain	Recruiting	16.12.2022

Trial locations

Investigated drugs:

Acetylsalicylic Acid

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.

Investigated diseases:

Pre-eclampsia

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 ID:

2023-503698-40-00

Protocol code:

FFIS/2019/01/AS

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Aspirin for Preventing Preeclampsia in Twin Pregnancies

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