Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation

Placental Insufficiency Clinical Trial

— ASAP  

Official title:

Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01616615
• Other study ID #: ASAP
• Secondary ID: 2012-000622-22
• Status: Completed
• Phase: Phase 2
• First received: June 8, 2012
• Last updated: August 17, 2015
• Start date: September 2012
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Placental Insufficiency

Intervention

Drug:
• Aspirin
150 mg/day oral use
• placebo
1 capsule / day oral use

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona
Spain	Institut Dexeus	Barcelona
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Sara Varea

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uterine artery mean pulsatility		at 28 weeks of gestation	No
Secondary	Pre-eclampsia	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	delivery	Yes
Secondary	Severe preeclampsia	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).	at delivery	Yes
Secondary	Intrauterine Growth Retardation	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.	at delivery	No
Secondary	Significant neonatal morbidity	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	at delivery	Yes
Secondary	number of cesarean	Emergent cesarean section due to fetal wellbeing loss Birth weight	at delivery	No
Secondary	Neonatal acidosis	Neonatal acidosis (arterial pH <7.10 + Base excess(BE)> 12 milliequivalent (mEq) / L)	at delivery	No
Secondary	Perinatal mortality	Perinatal mortality (> 22 weeks gestation, <28 days postpartum)	28 days post partum	No
Secondary	Days in the Neonatal Intensive Care Unit		28 days post partum	No