Transplacental Aspirin Therapy for Early Onset Fetal Growth Restriction

NCT04557475 | Withdrawn Phase 3

• 1 other identifier: IRB00259253
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fetal Growth Restriction; Fetal Growth Retardation; Intrauterine Growth Restriction; Intrauterine Growth Retardation

Keywords

Maternal Aspirin Therapy

Outcome Measures

Primary Outcomes (1)

• Number of fetuses delivered for non-reassuring fetal status prior to 32+0 week's gestation

  To determine the frequency of delivery prior to 32+0 weeks' gestation for abnormal fetal surveillance parameters.

  From randomization until birth, up to 38 weeks gestation

Secondary Outcomes (7)

• Change in UA Doppler index

  Baseline and weekly, up to 38 weeks gestation

• Change in amniotic fluid index (AFI)

  Baseline and weekly, up to 38 weeks gestation

• Change in fetal heart rate decelerations

  Baseline and weekly to bi-weekly, up to 38 weeks gestation

• Change in biophysical profile score

  Baseline and weekly to bi-weekly, up to 38 weeks gestation

• Gestational age at delivery

  At time of birth, up to 38 weeks gestation

Study Arms (2)

ASA Group

EXPERIMENTAL

Receives standard of care and intervention.

Drug: Aspirin

SOC Group

NO INTERVENTION

Receives standard of care (SOC), only

Interventions

Aspirin DRUG

Two tablets daily with dinner

Also known as: acetylsalicylic acid (ASA)

ASA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Related Publications (32)

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MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ahmet A Baschat

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Ashi R Daftary, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two Group Assignment

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 21, 2020
• Study Start: June 11, 2022
• Primary Completion: June 11, 2023
• Study Completion: June 11, 2023
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share