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Clinical Trials/NCT01616615
NCT01616615
Completed
Phase 2

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

Sara Varea3 sites in 1 country190 target enrollmentSeptember 2012
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ConditionsPlacental Insufficiency
InterventionsAspirinplacebo
DrugsAspirinplacebo

Overview

Phase
Phase 2
Intervention
Aspirin
Conditions
Placental Insufficiency
Sponsor
Sara Varea
Enrollment
190
Locations
3
Primary Endpoint
Uterine artery mean pulsatility
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
April 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Sara Varea
Responsible Party
Sponsor Investigator
Principal Investigator

Sara Varea

Clinical Trial Manager

Fundacion Clinic per a la Recerca Biomédica

Eligibility 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

Arms & Interventions

ASPIRIN

150 mg milligram(s)/ day oral use

Intervention: Aspirin

PLACEBO

Intervention: placebo

Outcomes

Primary Outcomes

Uterine artery mean pulsatility

Time Frame: at 28 weeks of gestation

Secondary Outcomes

  • Pre-eclampsia(delivery)
  • Severe preeclampsia(at delivery)
  • Intrauterine Growth Retardation(at delivery)
  • Significant neonatal morbidity(at delivery)
  • number of cesarean(at delivery)
  • Neonatal acidosis(at delivery)
  • Perinatal mortality(28 days post partum)
  • Days in the Neonatal Intensive Care Unit(28 days post partum)

Study Sites (3)

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