Recruiting

Phase 3

AspirinAspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

Sponsor:

The George Washington University Biostatistics Center

Code:

NCT06980025

Conditions

Preterm Delivery

Obstetrical Complications

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Accepted

Interventions

162mg Aspirin

81mg Aspirin

Study Details

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

Study ID

NCT06980025

Start date

Jul 1, 2025

Status verified date

Apr, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Accepted

Inclusion Criteria:

14 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.

Exclusion Criteria:

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
Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from twins to singleton, is not an exclusion.
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.
Participation in another interventional study that influences the primary outcome in this study (gestational age at delivery).
Participation in this trial in a previous pregnancy.
Delivery planned at a non-participating site

Study Design

Enrollment

1800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 162mg Aspirin Daily

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

experimental: 81mg Aspirin Daily

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

Interventions

162mg Aspirin

Two 81mg aspirin tablets in an over-encapsulated capsule filled with microcrystalline cellulose.

Study intervention will be packaged into bottles (35 capsules per bottle).

81mg Aspirin

One 81mg aspirin tablet in an over-encapsulated capsule filled with microcrystalline cellulose.

Study intervention will be packaged into bottles (35 capsules per bottle).

Primary outcome measure

Rate of recurrent preterm delivery or fetal death prior to 35 weeks 0 days gestation [ Time Frame: Between randomization and 35 weeks, 0 days gestation (a period of up to 25 weeks) ]

Central Contacts and Locations

Central contacts

Rebecca G Clifton, PhD

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

Trisha Boekhoudt, MPH

trishab@bsc.gwu.edu

Locations

University of Alabama - Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Nancy Saxon, RN, BSN

205-934-1616 nbsaxon@uabmc.edu

Principal Investigator:

Alan TN Tita, MD

Regents of the University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Natalie Oman, MPH

206-718-4703 natalie.oman@ucsf.edu

Principal Investigator:

Mary Norton, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Elizabeth Rangel, RN

312-503-6287 elizabeth.rangel@northwestern.edu

Principal Investigator:

Lynn Yee, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Megan Loffredo, MD, CCRC

203-722-1058 ml4639@cumc.columbia.edu

Principal Investigator:

Uma Reddy, MD

University of North Carolina - Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Kelly Clark, RN

919-350-6117 kelly_clark@med.unc.edu

Principal Investigator:

John M Thorp, Jr., MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Jennifer Ferrara, RNC MSN

919-681-6176 jennifer.ferrara@duke.edu

Principal Investigator:

Brenna Hughes, MD

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Abigail Pierse, BS

216-778-8443 apierse@metrohealth.org

Principal Investigator:

Kelly Gibson, MD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Anna Bartholomew, RN, BSN

614-685-3229 anna.bartholomew@osumc.edu

Principal Investigator:

Maged Costantine, MD

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Christina Pizzi, RN

267-273-8574 christina.pizzi@pennmedicine.upenn.edu

Principal Investigator:

Samuel Parry, MD

Magee Women's Hospital of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jeanette Boyce, RN

412-527-8118 tessje@upmc.edu

Principal Investigator:

Hyagriv Simhan, MD

Brown University

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Angelica DeMartino, RN, BSN

401-274-1122 amdemartino@wihri.org

Principal Investigator:

Dwight J Rouse, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Christina Reed, RN, NP

832-826-7377 christina.reed@bcm.edu

Jia Chen, RN, CCRP

713-798-3798 jia.chen@bcm.edu

Principal Investigator:

Catherine Eppes, MD, MPH

University of Texas - Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Felecia Ortiz, RN

713-500-6467 Felecia.Ortiz@uth.tmc.edu

Principal Investigator:

Hector Mendez-Figueroa, MD

University of Utah Medical Center

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Amber Sowles, RN BSN

801-585-5499 amber.sowles@hsc.utah.edu

Principal Investigator:

Torri Metz, MD

More Information

Sponsor

The George Washington University Biostatistics Center

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

Preterm Delivery
Stillbirth
Maternal Morbidity
Neonatal Morbidity
Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The George Washington University Biostatistics Center on 2026-04-09.