Prevention of Preeclampsia With Aspirin in Recipients of Donated Oocytes.

Phase 3

Terminated

• Conditions: Pre-Eclampsia
• Interventions: Drug: Acetylsalicylic acid; Drug: Placebo

• Registration Number: NCT02174328
• Lead Sponsor: 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.

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-09-11
• Study Start: 2014-05-21
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-25
• Primary Completion: 2018-04-20
• Study Completion: 2018-04-20
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 81

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acetylsalicylic acid	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
Placebo	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

Primary Outcome Measures

Name	Time	Method
Occurrence of preeclampsia.	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

Name	Time	Method
Other complications	Up to 42 weeks	Determine the development of gestational hypertension, severe preeclampsia, IUGR, and preterm delivery in this group of patients.

Trial Locations

Locations (1)

Obstetrics Unit of La Fe University and Politechnic Hospital; 🇪🇸 Valencia, Spain