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

Sara Varea

Status and phase: Completed; Phase 2

Conditions: Placental Insufficiency

Treatments: Drug: Aspirin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01616615

ASAP

2012-000622-22 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 190 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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190 participants in 2 patient groups, including a placebo group

ASPIRIN

Experimental group

Description:

150 mg milligram(s)/ day oral use

Treatment:

Drug: Aspirin

PLACEBO

Placebo Comparator group

Treatment:

Drug: placebo