Transplacental Aspirin Therapy for Early Onset Fetal Growth Restriction

• Status: Withdrawn
• Trial end date: 2023-06-11
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this investigation is to evaluate the ability of maternal aspirin (ASA) therapy to prevent preterm birth for fetal indications prior to 32 weeks gestation in women with early onset Fetal Growth Restriction (FGR). Aspirin is a commonly used medication that blocks blood platelets from clumping. Aspirin crosses the placenta in a dose dependent mode. There is preliminary evidence in smaller studies that aspirin can block fetal platelet clumping and, therefore, slow down the progression of placental disease under specific circumstances. The optimal time for aspirin to work is when the fetus' placental dysfunction is still mild. The goal of this research study is to show if fetuses that receive aspirin through maternal intake at a dose shown to affect fetal platelet aggregation will be less likely to deliver before 32 weeks for fetal deterioration. The outcomes of patients that receive aspirin will be compared to women that receive standard FGR management but do not take any aspirin. The decision if a study participant receives aspirin or not will be randomly picked. Such a research study is called a randomized controlled trial.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• Pregnant women at least 18 years old

• Gestational age between 220/7 to 300/7 weeks

• Fetal abdominal circumference < 10th percentile

• Umbilical artery Doppler index elevation > 95th percentile

• Forward umbilical artery end-diastolic flow

• Able to understand purpose, risks/benefits, and voluntary nature of study participant

Exclusion Criteria:

• Multiple pregnancy

• Currently taking 81 mg aspirin

• Maternal contraindication to aspirin treatment including allergy

• Active vaginal bleeding

• Presence of any physical fetal anomaly

• Fetal viral infection if diagnosed by the appropriate diagnostic test

• Fetal chromosomal abnormalities if diagnosed by invasive fetal testing

• Need for imminent delivery