Aspirin Dosing for Preventing Recurrent Preterm Delivery
This study is looking at whether a higher dose of aspirin (162mg) is better than a standard dose (81mg) at preventing preterm delivery (birth before 37 weeks of pregnancy) or fetal death in pregnant individuals who have had a preterm birth before. You could be eligible if you are 14 years or older and are pregnant with one baby. The study will involve 1,800 participants and will compare the two aspirin doses. The main goal is to see if one dose is more effective at preventing preterm delivery or fetal death before 35 weeks of pregnancy. The study is currently unclear about its status.
- Study design
- This is a large, multi-center study where 1,800 participants will be randomly assigned to receive either 162mg or 81mg of aspirin daily, without knowing which dose they are getting (double-blind).
- What's involved
- You would take either 162mg or 81mg of aspirin daily, starting between 10 and 15 weeks of pregnancy and continuing through 36 weeks and 6 days of pregnancy.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main outcome is measured between randomization and 35 weeks, 0 days gestation, which could be up to 25 weeks.
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NCT06980025
Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
Recruiting
PHASE3Ages 14+InterventionalPreventionThe George Washington University Biostatistics CenterInvestigator-initiated
~1,800 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:162mg Aspirin81mg Aspirin
At a glance
Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of recurrent preterm delivery or fetal death prior to 35 weeks 0 days gestation
Measured over Between randomization and 35 weeks, 0 days gestation (a period of up to 25 weeks)
Conditions
Where it's being run
14 sites across 10 statesNorth Carolina2
Ohio2
Pennsylvania2
Texas2
Alabama1
California1
Illinois1
New York1
Study leadership
- Rebecca G Clifton, PhD · PRINCIPAL_INVESTIGATOR · The George Washington University Biostatistics Center
- Matthew K Hoffman, MD, MPH · PRINCIPAL_INVESTIGATOR · ChristianaCare Center for Women & Children's Health Research
- Uma M Reddy, MD, MPH · PRINCIPAL_INVESTIGATOR · Columbia University
- Cande Ananth, PhD, MPH · PRINCIPAL_INVESTIGATOR · Robert Wood Johnson Medical School - Rutgers Health
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Rate of recurrent preterm delivery or fetal death prior to 35 weeks 0 days gestationBetween 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.