NCT06980025 · The George Washington University Biostatistics Center
Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
(ADEPT)
What this study is about
This is a phase-III multi-center where neither patients nor doctors know which treatment is given randomly assigned clinical trial of 1,800 individuals with a history of prior preterm birth at less than 35 weeks gestation who are randomly assigned to either 162 mg aspirin or 81 mg aspirin daily.
View original scientific description
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.
Interventions
DRUG
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).
DRUG
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 measures
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)
Number and rate of participants who experience a recurrent preterm delivery or fetal death before 35 weeks, 0 days gestation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 allerg
Where
- Birmingham, Alabama
- San Francisco, California
- Chicago, Illinois
- New York, New York
- Chapel Hill, North Carolina
- Durham, North Carolina
- Cleveland, Ohio
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Providence, Rhode Island
- Houston, Texas
And 1 more location — see the full list below.
Collaborators
Columbia University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations