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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
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pre-Eclampsia Drug: Acetylsalicylic acid Drug: Placebo Phase 3

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
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
Drug: Placebo
Placebo once a day until 36 week
Other Name: Not active drug




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Spain
Obstetrics Unit of La Fe University and Politechnic Hospital
Valencia, Spain, 46026
Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
Principal Investigator: Alfredo Perales, PhD La Fe University Hospital

Publications:

Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT02174328     History of Changes
Other Study ID Numbers: PrOvAS001
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Instituto de Investigacion Sanitaria La Fe:
See incidence of Pre-Eclampsia in acetylsalicylic acid group
See incidence of Pre-Eclampsia in placebo group

Additional relevant MeSH terms:
Aspirin
Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics