PREECLAMPSIA
Conditions
Interventions
Trade Name: Aspirin
Product Name: Aspirin
Product Code: N02B A01
Pharmaceutical Form: Tablet
INN or Proposed INN: Acido acetilsalicílico
CAS Number: 50-78-2
Current Sponsor code: AAS
Other descriptiv
Sponsors
Instituto de Investigación Sanitaria La Fe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients over 18 years. - Patients receiving oocyte donation. - Patients who have become pregnant. - Single or multiple gestations. - To accept the conditions of the study by signing the appropriate informed consent single pregnancies Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 372 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Known allergy to ASA. - History of peptic ulcer. - Use of prostaglandin inhibitors within 10 days before the start of the study. - History of chronic renal disease, thyroid, liver or heart disease. - Psychiatric or cognitive pathology that prevents the understanding of the conditions of informed consentKnown allergy to ASA. - History of peptic ulcer. - Use of prostaglandin inhibitors within 10 days before the start of the study. - History of chronic renal disease, thyroid, liver or heart disease. - Psychiatric or cognitive pathology that prevents the understanding of the conditions of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: determine the development of gestational hypertension, preeclampsia severe CIR and preterm delivery in this group of patients. Also in this study is to find whether, ASA by blocking cyclo-oxygenase-2 could act in addition to reducing the synthesis of thromboxane A 2, by modifying or reducing the formation of various inflammatory mediators involved in angiogenesis;Primary end point(s): Family history of preeclampsia or CIR. - Medical history (hypertension, diabetes mellitus ...) and surgical - Allergy to medicines. - Current treatment and previous treatments used. - Obstetric history. - Gynecological history. - Age of the patient. - Weight and height, calculation of BMI. - Raza. - Smoking. - Determination of weight gain during pregnancy and physical examination to detect the potential occurrence of edema. - Determination of Blood Pressure and Proteinuria: determine the value the blood pressure and protein in urine throughout pregnancy at intervals of one month (in order to detect gestational hypertension Pre-eclampsia). Blood pressure measurement by digital sphygmomanometer. To evaluate the presence of protein in urine by conducting strips, and if it detects two crosses, proceed to the request of abnormal urinary sediment. - Analytical Basic throughout pregnancy intervals of three months (in order to identify criteria for severity). - Ultrasound Findings: length cefalonalga (LCN), nuchal translucency (NT), fetal biometry estimated fetal weight (PFE) and ductus venosus Doppler study, umbilical artery and MCA in normal controls (in order to detect CIR). It also performed uterine artery Doppler study between 11 and 13 weeks of gestation to determine the pulsatility index. - Determination maternal plasma: PAPP-A and beta-HCG (in weeks 11-13). - Determination maternal plasma VEGF, PlGF, sFlt-1 and sEng in 2 times (11-13 weeks, and weeks 18-22). - Gestational age at the time of termination, fnalización mode, sex and birth weight, Apgar score;Timepoint( | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Family history of preeclampsia or CIR. - Medical history (hypertension, diabetes mellitus ...) and surgical - Allergy to medicines. - Current treatment and previous treatments used. - Obstetric history. - Gynecological history. - Age of the patient. - Weight and height, calculation of BMI. - Raza. - Smoking. - Determination of weight gain during pregnancy and physical examination to detect the potential occurrence of edema. - Determination of Blood Pressure and Proteinuria: determine the value the blood pressure and protein in urine throughout pregnancy at intervals of one month (in order to detect gestational hypertension Pre-eclampsia). Blood pressure measurement by digital sphygmomanometer. To evaluate the presence of protein in urine by conducting strips, and if it detects two crosses, proceed to the request of abnormal urinary sediment. - Analytical Basic throughout pregnancy intervals of three months (in order to identify criteria for severity). - Ultrasound Findings: length cefalonalga (LCN), nuchal translucency (NT), fetal biometry estimated fetal weight (PFE) and ductus venosus Doppler study, umbilical artery and MCA in normal controls (in order to detect CIR). It also performed uterine artery Doppler study between 11 and 13 weeks of gestation to determine the pulsatility index.Determination maternal plasma: PAPP-A and beta-HCG (in weeks 11-13). - Determination maternal plasma VEGF, PlGF, sFlt-1 and sEng in 2 times (11-13 weeks, and weeks 18-22). - Gestational age at the time of termination, endingmode, sex and birth weight, Apgar score.;Timepoint(s) of evaluation of this end point: Completion of gestiacion | — |
Countries
Spain
Contacts
Public ContactUREC
Instituto de Investigacion Sanitaria La Fe
Outcome results
None listed