A Phase 3 interventional study of Acetylsalicylic acid in Embryo Transfer and Hypertension, Pregnancy Induced, sponsored by Centre Hospitalier Universitaire de Liege. Recruiting at 1 site in Belgium. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Centre Hospitalier Universitaire de Liege · Phase 3, Interventional, and Prevention
Title: A prospective multicentric interventional randomized controlled trial to assess the effect of low dose acetylsalicylic acid as a preventive treatment of pre-eclampsia in pregnant women who underwent frozen embryo transfer
Method: Prospective, interventional, multicentric randomized controlled trial, to evaluate the utility of a preventive treatment with low dose acetylsalicylic acid from the embryo transfer and throughout pregnancy in patients who have had a frozen embryo transfer.
During the first consultation, patients will be introduced to the study. They can choose to participate or not. If they agree to participate, they will be randomized in two groups (1:1), treated or not. The randomization will be realized by the RedCap software. Patients with natural and modified natural cycle and hormone replacement treatment (HRT) cycle will be included. As soon as an evolutive intrauterine pregnancy is diagnosed, in the treated group, she will receive a daily dose of 160mg acetylsalicylic acid, until 36 weeks of amenorrhea. Patients of both groups will be followed twice a month (regular prenatal visit and phone call).
Primary goal: To assess the incidence of pre-eclamspia in women who underwent a frozen embryo transfer treated with 160mg of acetylsalicylic acid versus no treatment.
Primary endpoint: Mean number of women suffering from preeclampsia in the treated and not treated groups.
Secondary goals:
Secondary Endpoint 3: mean number of miscarriage
Secondary Endpoint 4: mean number of pre-eclampsia
Duration: the study duration for the participant will be maximum 12 months (from inclusion before embryo transfer until delivery). The total duration study will be maximum 4 years from the first patient first inclusion visit until the last visit of study patient.
Number of participants: 120 patients per group, HRT cycle versus without treatment, spontaneous cycle vs without treatment. Due to miscarriage risk, a total of 276 women will be enrolled.
Inclusion criteria:
Exclusion criteria
262 studies on the registry are indexed under Hypertension, Pregnancy-Induced; 71 are open to participants now.
This study's planned enrollment of 276 is above the median of 147 across 174 interventional studies indexed under Hypertension, Pregnancy-Induced.
Browse Hypertension, Pregnancy-Induced studies →Centre Hospitalier Universitaire de Liege is the lead sponsor of 40 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Acetylsalicylic acid
160mg once a day
Mean number of women suffering from pre-eclampsia in the treated and not treated groups.
Time frame: 4 years
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2022 (actual). Primary completion is estimated for Dec 2025, 38 months after the start.
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Hypertension, Pregnancy-Induced →
Centre Hospitalier Universitaire de Liege