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

NCT ID: NCT01616615

Last Updated: 2015-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Placental Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ASPIRIN

150 mg milligram(s)/ day oral use

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

150 mg/day oral use

PLACEBO

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

1 capsule / day oral use

Interventions

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Aspirin

150 mg/day oral use

Intervention Type DRUG

placebo

1 capsule / day oral use

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sara Varea

OTHER

Sponsor Role lead

Responsible Party

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Sara Varea

Clinical Trial Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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FRANCESC FIGUERAS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

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Hospital Clinic of Barcelona

Barcelona, Barcelona, Spain

Site Status

Institut Dexeus

Barcelona, Barcelona, Spain

Site Status

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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2012-000622-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ASAP

Identifier Type: -

Identifier Source: org_study_id

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