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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Fundacion Clinic per a la Recerca Biomédica
Sponsor:
Information provided by (Responsible Party):
Sara Varea, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier:
NCT01616615
First received: June 8, 2012
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Placental Insufficiency
Drug: Aspirin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation

Resource links provided by NLM:


Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Uterine artery mean pulsatility [ Time Frame: at 28 weeks of gestation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pre-eclampsia [ Time Frame: delivery ] [ Designated as safety issue: Yes ]
    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

  • Severe preeclampsia [ Time Frame: at delivery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    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 [ Time Frame: at delivery ] [ Designated as safety issue: Yes ]
    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

  • number of cesarean [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    Emergent cesarean section due to fetal wellbeing loss Birth weight

  • Neonatal acidosis [ Time Frame: at delivery ] [ Designated as safety issue: No ]
    Neonatal acidosis (arterial pH <7.10 + Base excess(BE)> 12 milliequivalent (mEq) / L)

  • Perinatal mortality [ Time Frame: 28 days post partum ] [ Designated as safety issue: No ]
    Perinatal mortality (> 22 weeks gestation, <28 days postpartum)

  • Days in the Neonatal Intensive Care Unit [ Time Frame: 28 days post partum ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASPIRIN
150 mg milligram(s)/ day oral use
Drug: Aspirin
150 mg/day oral use
Placebo Comparator: PLACEBO Drug: placebo
1 capsule / day oral use

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 45-48mm)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616615

Contacts
Contact: Francesc Figueras, MD, PhD FFIGUERA@CLINIC.UB.ES
Contact: Sara Varea, BSc svarea@clinic.ub.es

Locations
Spain
Hospital Clinic of Barcelona Recruiting
Barcelona, Spain, 08028
Contact: Francesc Figueras    +34932275400    ffiguera@clinic.ub.es   
Principal Investigator: Francesc Figueras Retuerta, MD,PhD         
Institut Dexeus Recruiting
Barcelona, Spain, 08028
Contact: Elena SCAZZOCCHIO, MD       ELESCA@DEXEUS.COM   
Principal Investigator: Elena Scazzocchio, MD         
Hospital Clínico Lozano Blesa Recruiting
Zaragoza, Spain, 50009
Contact: Daniel Oros, MD       dorosl@salud.aragon.es   
Principal Investigator: Daniel Oros, MD         
Sponsors and Collaborators
Sara Varea
Investigators
Principal Investigator: FRANCESC FIGUERAS, MD, PhD Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Sara Varea, Clinical Trial Manager, Fundació Clínic per la Recerca Biomèdica
ClinicalTrials.gov Identifier: NCT01616615     History of Changes
Other Study ID Numbers: ASAP, 2012-000622-22
Study First Received: June 8, 2012
Last Updated: August 20, 2014
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Placental Insufficiency
Placenta Diseases
Pregnancy Complications
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014