Prevention of Preeclampsia With Aspirin Administered From the Beginning of Pregnancy in Recipients of Donated Oocytes.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Occurrence of preeclampsia.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Acetylsalicylic acid (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of preeclampsia.
时间窗: 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.
次要结局
- Other complications(Up to 42 weeks)