Placental Insufficiency
Conditions
Brief summary
To establish wether a prophylactic intervention from first trimester with low-dose of aspirin improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester
Interventions
DRUGAspirin
150 mg/day oral use
DRUGplacebo
1 capsule / day oral use
Sponsors
Sara Varea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years old attending for routine ultrasound at first trimester of pregnancy between 11 and 14 weeks of gestation (Crown-to rump length 45-48mm) * Single gestation * Mean pulsatility index of the uterine arteries above the 95th percentile for our population
Exclusion criteria
* Pre-existing hypertension, renal or cardiovascular disease * previous history of pre-eclampsia * Pregestational diabetes * Systemic lupus Erythematosus * Gastric ulcer * Acetylsalicylic acid or lactose hypersensitivity * Bleeding disorders * Fetal disorders (including chromosomal abnormalities) * Administration of low molecular weight heparin * Concomitant treatment with aspirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uterine artery mean pulsatility | at 28 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe preeclampsia | at delivery | Severe preeclampsia defined as: preeclampsia criteria + DBP\> = 110 mmHg, proteinuria\> 5g/24h, oligouria (\<400 ml/24h), neurological symptoms (brain or visual), acute pulmonary edema (gasometric and radiological criteria), persistent epigastric pain, abnormal liver function (AST or Alanine aminotransferase(ALT)\> 70 IU), analytical signs of hemolysis (LDH\> 700 U / L) and / or thrombocytopenia (\<100.000/ml). |
| Intrauterine Growth Retardation | at delivery | Intrauterine Growth Retardation: birth weight below the 10th percentile of our population + pulsatility index in umbilical artery in the third trimester (on two separate occasions \>48h)above the 95th percentile. |
| Significant neonatal morbidity | at delivery | Significant neonatal morbidity (convulsions, intraventricular hemorrhage\> grade III, periventricular leukomalacia, hypoxic-ischemic encephalopathy, abnormal electroencephalogram, necrotizing enterocolitis, acute renal failure (serum creatinine\> 1.5 mg / dl) or heart failure (requiring inotropic agents |
| Pre-eclampsia | delivery | pre-eclampsia defined as: diastolic blood pressure (DBP)\> = 90 mmHg) or systolic (SBP)\> = 140 mmHg on two separated determinations (\> 4h) with proteinuria\> 300 mg/24 h -Gestational age at debut of preeclampsia |
| Neonatal acidosis | at delivery | Neonatal acidosis (arterial pH \<7.10 + Base excess(BE)\> 12 milliequivalent (mEq) / L) |
| Perinatal mortality | 28 days post partum | Perinatal mortality (\> 22 weeks gestation, \<28 days postpartum) |
| Days in the Neonatal Intensive Care Unit | 28 days post partum | — |
| number of cesarean | at delivery | Emergent cesarean section due to fetal wellbeing loss Birth weight |
Countries
Spain
Outcome results
None listed