Placental insufficiency MedDRA version: 14.1 Level: PT Classification code 10035138 Term: Placental insufficiency System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Trade Name: Tromatyl 150 mg prolonged-release hard capsules
Product Name: Tromatyl 150 mg prolonged-release hard capsules
Product Code: NA
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: acety
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
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: 45-48 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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish wether a prophylactic intervention from first trimestre with low-dose of aspirine improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery Doppler at first trimester.;Secondary Objective: -To establish wether a prophylactic intervention with low-dose of aspirin results in a lower incidence or preeclampsia in pregnant women defined as high-risk by abnormal uterine artery Doppler at first trimester. -To establish wether a prophylactic intervention with low-dose of aspirin results in a lower incidence of intrauterine growth retardation in pregnant women defined as high-risk by abnormal uterine artery Doppler at first trimester. -To establish wether a prophylactic intervention with low-dose of aspirin results in a lower incidence of births below 34 weeks in pregnant women defined as high-risk by abnormal uterine artery Doppler at first trimester.;Primary end point(s): -Uterine artery mean pulsatility index at 28 weeks.;Timepoint(s) of evaluation of this end point: Delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Uterine artery pulsatility index at 28 weeks. -Pre-eclampsia: 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 -Severe preeclampsia: preeclampsia criteria + DBP> = 110 mmHg, proteinuria> 5g/24h, oligouria ( 70 IU), analytical signs of hemolysis (LDH> 700 U / L) and / or thrombocytopenia (48h) above the 95th percentile. -Emergent cesarean section due to fetal wellbeing loss -Birth weight -Neonatal acidosis (arterial pH 12 mEq / L) -Perinatal mortality (> 22 weeks gestation, 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).;Timepoint(s) of evaluation of this end point: Delivery | — |
Countries
Spain
Contacts
Public ContactCTU Clinic-Farmacología clinica
Fundació Clinic per a la Recerca Biomèdica
Outcome results
None listed