Prevention of Preeclampsia With Aspirin in Recipients of Donated Oocytes. (PROVAS)

April 25, 2019 updated by: Instituto de Investigacion Sanitaria La Fe

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

81

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Obstetrics Unit of La Fe University and Politechnic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Not active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 42 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 42 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 42 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Principal Investigator: Alfredo Perales, PhD, La Fe University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2014

Primary Completion (Actual)

April 20, 2018

Study Completion (Actual)

April 20, 2018

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

June 24, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PrOvAS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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