Status:
RECRUITING
Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborating Sponsors:
Columbia University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preterm Delivery
Obstetrical Complications
Eligibility:
FEMALE
14+ years
Phase:
PHASE3
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 a...
Detailed 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 a...
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
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT06980025
Start Date
June 10 2025
End Date
February 28 2029
Last Update
October 31 2025
Active Locations (14)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
2
Regents of the University of California San Francisco
San Francisco, California, United States, 94143
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Columbia University
New York, New York, United States, 10032