A Phase 3 interventional study of Acetylsalicylic acid and Placebo in Pre-Eclampsia, sponsored by Instituto de Investigacion Sanitaria La Fe. Terminated at 1 site in Spain. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-04-26.
Sponsored by Instituto de Investigacion Sanitaria La Fe · Phase 3, Interventional, and Prevention
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.
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).
904 studies on the registry are indexed under Pre-Eclampsia; 240 are open to participants now.
This study's enrollment of 81 is below the median of 110 across 478 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Instituto de Investigacion Sanitaria La Fe is the lead sponsor of 59 studies on the registry; 15 are open to participants now.
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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
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
Acetylsalicylic acid once a day until 36 week
Also known as: ADIRO 100
Placebo once a day until 36 week
Also known as: Not active drug
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.
Time frame: Up to 42 weeks
Other complications
Determine the development of gestational hypertension, severe preeclampsia, IUGR, and preterm delivery in this group of patients.
Time frame: Up to 42 weeks
Inflammatory mediators involved in angiogenesis.
Another objective is to determine if aspirin, through blockade of cyclooxygenase-2, could act in addition to reducing the synthesis of thromboxane 2, altering or diminishing the formation of various inflammatory mediators involved in angiogenesis.
Time frame: Up to 42 weeks
Plan to share: No
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aspirin
Instituto de Investigacion Sanitaria La Fe