Prevention of Preeclampsia With Aspirin in Recipients of Donated Oocytes. (PROVAS)
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|ClinicalTrials.gov Identifier: NCT02174328|
Recruitment Status : Suspended (Halted prematurely due to low recruitment rate.)
First Posted : June 25, 2014
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pre-Eclampsia||Drug: Acetylsalicylic acid Drug: Placebo||Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Prevention of Preeclampsia With Aspirin Administered From the Beginning of Pregnancy in Recipients of Donated Oocytes.|
|Actual Study Start Date :||May 21, 2014|
|Estimated Primary Completion Date :||May 31, 2018|
|Estimated Study Completion Date :||May 31, 2018|
Experimental: acetylsalicylic acid
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
Acetylsalicylic acid once a day until 36 week
Other Name: ADIRO 100
Placebo Comparator: Placebo
This group will receive 1 tablet of placebo orally each day from 5-10 weeks gestation until the end of gestation, about week 36
Placebo once a day until 36 week
Other Name: Not active drug
- Occurrence of preeclampsia. [ Time Frame: Up to 42 weeks ]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.
- Other complications [ Time Frame: Up to 42 weeks ]Determine the development of gestational hypertension, severe preeclampsia, IUGR, and preterm delivery in this group of patients.
- Inflammatory mediators involved in angiogenesis. [ Time Frame: Up to 42 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174328
|Obstetrics Unit of La Fe University and Politechnic Hospital|
|Valencia, Spain, 46026|
|Principal Investigator:||Alfredo Perales, PhD||La Fe University Hospital|