Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

NCT06980025 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: HD109332-ADEPTU01HD109332U24HD036801
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 14

Brief Summary

This is a phase-III multi-center double-blind randomized clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomized to either 162 mg aspirin or 81 mg aspirin daily. The study drug will be initiated between 10 and 15 weeks gestation and continued through 36 weeks, 6 days gestation. The primary endpoint is recurrent preterm delivery or fetal death prior to 35 weeks, 0 days gestation.

Conditions

Preterm Delivery; Obstetrical Complications

Keywords

Preterm Delivery; Stillbirth; Maternal Morbidity; Neonatal Morbidity; Prevention

Outcome Measures

Primary Outcomes (1)

• Rate of recurrent preterm delivery or fetal death prior to 35 weeks 0 days gestation

  Number and rate of participants who experience a recurrent preterm delivery or fetal death before 35 weeks, 0 days gestation.

  Between randomization and 35 weeks, 0 days gestation (a period of up to 25 weeks)

Secondary Outcomes (1)

• Rate of ischemic placental disease

  Between randomization and delivery (a period of up to 32 weeks)

Other Outcomes (38)

• Rate of recurrent preterm delivery or fetal death at <28 weeks

  Between randomization and delivery (a period of up to 18 weeks)

• Rate of recurrent preterm delivery or fetal death at <37 weeks

  Between randomization and delivery (a period of up to 27 weeks)

• Rate of ischemic placental disease with delivery prior to 28 weeks

  Between randomization and delivery (a period of up to 18 weeks)

Study Arms (2)

162mg Aspirin Daily

EXPERIMENTAL

One 81mg capsule of aspirin daily through 36 weeks 6 days gestation.

Drug: 162mg Aspirin

81mg Aspirin Daily

EXPERIMENTAL

Two 81mg capsules of aspirin daily through 36 weeks 6 days gestation.

Drug: 81mg Aspirin

Interventions

162mg Aspirin DRUG

Two 81mg aspirin tablets in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).

162mg Aspirin Daily

81mg Aspirin DRUG

One 81mg aspirin tablet in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).

81mg Aspirin Daily

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Singleton gestation. Twin gestation reduced to a singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 13 weeks 6 days project gestational age. Higher-order multifetal gestations reduced to singletons are not eligible.
• Gestational age at randomization between 10 weeks 0 days and 15 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
• Prior preterm birth between 20 weeks 0 days and 34 weeks 6 days with one of the following in the proximal birth reaching 20 weeks or greater:
• Spontaneous preterm birth is defined as spontaneous preterm labor or premature rupture of membranes
• Ischemic placental disease is defined as preeclampsia, small for gestational age, fetal growth restriction, or placental abruption, as defined clinically.
• Stillbirth excluding those with known genetic disorders or major congenital anomalies.

You may not qualify if:

• Known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., history of peptic ulcer disease, nasal polyps, NSAID-induced asthma, history of gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders, and consumption of 3 or more alcoholic drinks per day)
• Taking other anticoagulants such as Heparin or Low-Molecular weight Heparin
• Thrombocytopenia defined as a platelet count defined as a platelet count \<100,000 microliters
• Gastric bypass surgery, regardless of type
• Aspirin use \>81 mg daily during the current pregnancy who are not willing or able to go through a 2-week washout before randomization.
• Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery.
• Known fetal genetic disease or major malformations
• Any fetal/maternal condition requiring invasive in-utero assessment or treatment, for example, significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia.
• Patients with any of the following medical conditions because of increased risk for adverse pregnancy outcome or indicated preterm birth:
• Treated hypertension requiring more than one agent
• Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL
• Conditions treated with chronic oral glucocorticoid therapy (e.g., systemic lupus erythematosus)
• Uncontrolled hyper- and hypothyroid disease
• New York Heart Association (NYHA) stage II or greater cardiac disease
• Planned indicated delivery prior to 37 weeks.

Sponsors & Collaborators

• The George Washington University Biostatistics Center: lead
• Columbia University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (14)

University of Alabama - Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

Regents of the University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Columbia University

New York, New York, 10032, United States

RECRUITING

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

Case Western Reserve University

Cleveland, Ohio, 44109, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Brown University

Providence, Rhode Island, 02905, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Texas - Houston

Houston, Texas, 77030, United States

RECRUITING

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Stillbirth

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Rebecca G Clifton, PhD

  The George Washington University Biostatistics Center

  PRINCIPAL INVESTIGATOR

• Matthew K Hoffman, MD, MPH

  ChristianaCare Center for Women & Children's Health Research

  PRINCIPAL INVESTIGATOR

• Uma M Reddy, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

• Cande Ananth, PhD, MPH

  Robert Wood Johnson Medical School - Rutgers Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca G Clifton, PhD

CONTACT

(301) 881-9260; rclifton@bsc.gwu.edu

Trisha Boekhoudt, MPH

CONTACT

trishab@bsc.gwu.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study intervention is packaged and shipped from the central distribution center to the clinical sites. Participants, clinical staff, and clinical site investigators and research staff are masked to the study intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individuals will be randomized between 10 weeks, 0 days gestation and 15 weeks, 6 days gestation to either aspirin 162 mg or aspirin 81 mg daily and continue the study intervention through 36 weeks, 6 days gestation. Randomization will be stratified by clinical site.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (14)