Prevention of Preeclampsia With Aspirin in Recipients of Donated Oocytes.

Study Overview
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Brief Summary
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The main objective of this trial is to study the occurrence of preeclampsia in recipients of donated oocytes receiving aspirin at an early stage during pregnancy and to compare the results with those obtained in patients receiving placebo.

Detailed Description
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Various markers have been proposed for the early diagnosis of preeclampsia: determination of mean arterial pressure; presence of multiple risk factors of preeclampsia; biochemical, ultrasound, and angiogenic markers; uterine artery Doppler, etc. These are used to determinate which patients have an increased risk of developing preeclampsia during gestation, and therefore carry out closer monitoring of pregnancy in this population. In addition, these markers can also identify patients at increased risk of developing other problems such as IUGR or preterm labor. For nearly 30 years, there have been multiple studies trying to demonstrate that aspirin prevents the onset of preeclampsia with inconclusive results. However, recent studies in which aspirin was administered at an early stage (before 16 weeks of gestation) in patients at high risk of complications, have demonstrated a decrease in the incidence of this entity. Thus, administration of aspirin to patients at high risk (patients classified with a high risk of complications during pregnancy, based on markers mentioned above) seems to be useful in preventing onset of preeclampsia, IUGR and other complications, whenever it is administered at an early stage, as shown by several studies carried out so far. The incidence of preeclampsia, IUGR and other complications of pregnancy is increased in patients undergoing treatment for ovulation induction, being much higher in recipients of donated oocytes. It appears that this increase may be explained by immunological processes. The focus lies on the interaction between HLA-C fetal antigen with the maternal natural killer cells. We postulate, therefore, that the administration of aspirin in recipients of donated oocytes at an early stage of pregnancy, may also reduce the incidence of preeclampsia in this group of patients. Moreover, it has been observed that patients with preeclampsia exhibit lower levels of VEGF, PlGF and PAPP-A (factors involved in placental angiogenesis) and that this is accompanied by an increase in the sFlt1 (a potent PIGF and VEGF antagonist).

Official Title
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Prevention of Preeclampsia With Aspirin Administered From the Beginning of Pregnancy in Recipients of Donated Oocytes.

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Drug: Acetylsalicylic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years. Recipients of donated oocytes. Pregnant women. Single or twin gestations. Patients who accept the conditions of the study by signing the appropriate informed consent. Exclusion Criteria: Known allergy to acetylsalicylic acid . Personal history of peptic ulcer. Triplets. Use of prostaglandin inhibitors within 10 days prior to baseline. Personal history of chronic kidney, thyroid, liver or heart disease. Psychiatric or cognitive pathology that prevents understanding of the conditions of informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acetylsalicylic acid<br>This group will receive 1 tablet of acetylsalicylic acid (100 mg) orally daily from 5-10 weeks gestation until the end of gestation, about week 36 | Drug: Acetylsalicylic acid<br>* Acetylsalicylic acid once a day until 36 week<br>* Other names: ADIRO 100;|
| Placebo Comparator: Placebo<br>This group will receive 1 tablet of placebo orally each day from 5-10 weeks gestation until the end of gestation, about week 36 | Drug: Placebo<br>* Placebo once a day until 36 week<br>* Other names: Not active drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of preeclampsia. | The main objective is to study the occurrence of preeclampsia in recipients of donated oocytes receiving aspirin at an early stage during pregnancy, and to compare the results with those obtained in patients receiving placebo. | Up to 42 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other complications | Determine the development of gestational hypertension, severe preeclampsia, IUGR, and preterm delivery in this group of patients. | Up to 42 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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See incidence of Pre-Eclampsia in acetylsalicylic acid group, See incidence of Pre-Eclampsia in placebo group