se of Aspirin to improve the transport of blood to the fetus in patients with altered Doppler US
- Conditions
- Placental insufficiencyMedDRA version: 14.1Level: PTClassification code 10035138Term: Placental insufficiencySystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2012-000622-22-ES
- Lead Sponsor
- Fundació Clínic per a la Recerca Biomèdica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
-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: 45-48 mm)
-Single gestation
-Mean pulsatility index of the uterine arteries above the 95th percentile for our population
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 270
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Pre-existing hypertension, renal or cardiovascular disease
- previous history of preeclampsia
-Pregestational diabetes
-Systemic Lupus Erythematosus
-Gastric ulcer
-Acetylsalicylic acid or lactose Hypersensitivity
-Bleeding disorders
Fetal malformations (including chromosomal abnormalities)
-Administration of low molecular weight heparin
- concomitant treatment with aspirine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method