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

Primary Purpose

Placental Insufficiency

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Aspirin
placebo
Sponsored by
Sara Varea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placental Insufficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Clinic of Barcelona
  • Institut Dexeus
  • Hospital Clínico Lozano Blesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASPIRIN

PLACEBO

Arm Description

150 mg milligram(s)/ day oral use

Outcomes

Primary Outcome Measures

Uterine artery mean pulsatility

Secondary Outcome Measures

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
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).
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.
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
number of cesarean
Emergent cesarean section due to fetal wellbeing loss Birth weight
Neonatal acidosis
Neonatal acidosis (arterial pH <7.10 + Base excess(BE)> 12 milliequivalent (mEq) / L)
Perinatal mortality
Perinatal mortality (> 22 weeks gestation, <28 days postpartum)
Days in the Neonatal Intensive Care Unit

Full Information

First Posted
June 8, 2012
Last Updated
August 17, 2015
Sponsor
Sara Varea
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1. Study Identification

Unique Protocol Identification Number
NCT01616615
Brief Title
Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation
Acronym
ASAP
Official Title
Aspirin for the Enhancement of Trophoblastic Invasion in Women With Abnormal Uterine Artery Doppler at 11-14 Weeks of Gestation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sara Varea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placental Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASPIRIN
Arm Type
Experimental
Arm Description
150 mg milligram(s)/ day oral use
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
150 mg/day oral use
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 capsule / day oral use
Primary Outcome Measure Information:
Title
Uterine artery mean pulsatility
Time Frame
at 28 weeks of gestation
Secondary Outcome Measure Information:
Title
Pre-eclampsia
Description
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
Time Frame
delivery
Title
Severe preeclampsia
Description
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).
Time Frame
at delivery
Title
Intrauterine Growth Retardation
Description
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.
Time Frame
at delivery
Title
Significant neonatal morbidity
Description
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
Time Frame
at delivery
Title
number of cesarean
Description
Emergent cesarean section due to fetal wellbeing loss Birth weight
Time Frame
at delivery
Title
Neonatal acidosis
Description
Neonatal acidosis (arterial pH <7.10 + Base excess(BE)> 12 milliequivalent (mEq) / L)
Time Frame
at delivery
Title
Perinatal mortality
Description
Perinatal mortality (> 22 weeks gestation, <28 days postpartum)
Time Frame
28 days post partum
Title
Days in the Neonatal Intensive Care Unit
Time Frame
28 days post partum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FRANCESC FIGUERAS, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic of Barcelona
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Institut Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Clínico Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

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

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