Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
NCT ID: NCT06980025
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1800 participants
INTERVENTIONAL
2025-06-10
2029-02-28
Brief Summary
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Detailed Description
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The primary objective is to assess the efficacy of daily 162 mg of aspirin compared to 81 mg aspirin in reducing recurrent preterm delivery or fetal death before 35 weeks, 0 days gestation in individuals with a proximal birth between 20 weeks, 0 days and 34 weeks, 6 days gestation with spontaneous preterm delivery (sPTB), ischemic placental disease (IPD), or stillbirth. Ischemic placental disease includes small for gestational age, preeclampsia, or placental abruption.
The secondary objective is to assess the efficacy of daily 162 mg of aspirin compared to 81 mg aspirin in reducing ischemic placental disease in individuals with a proximal birth between 20 weeks, 0 days and 34 weeks, 6 days gestation with sPTB, IPD, or stillbirth.
Tertiary /Exploratory objectives are 1) to assess the efficacy of daily 162 mg of aspirin compared to 81 mg aspirin in reducing adverse maternal and neonatal outcomes, and 2) to assess maternal and neonatal safety in individuals with a proximal birth between 20 weeks, 0 days and 34 weeks, 6 days gestation with sPTB, IPD, or stillbirth.
Individuals will be randomized between 10 and 15 weeks gestation to either 162mg or 81mg of aspirin daily and continue the study intervention through 36 weeks, 6 days gestation. Participants will have monthly virtual or in-person visits through 37 weeks gestation to assess study intervention compliance, side effects, medication use, and unscheduled hospitalization. Maternal blood will be collected in a subset of the population. Research staff will abstract maternal and neonatal outcomes following delivery and discharge from the hospital.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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162mg Aspirin Daily
One 81mg capsule of aspirin daily through 36 weeks 6 days gestation.
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 Daily
Two 81mg capsules of aspirin daily through 36 weeks 6 days gestation.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
FEMALE
Yes
Sponsors
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Columbia University
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The George Washington University Biostatistics Center
OTHER
Responsible Party
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Principal Investigators
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Rebecca G Clifton, PhD
Role: PRINCIPAL_INVESTIGATOR
The George Washington University Biostatistics Center
Matthew K Hoffman, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
ChristianaCare Center for Women & Children's Health Research
Uma M Reddy, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Cande Ananth, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Robert Wood Johnson Medical School - Rutgers Health
Locations
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University of Alabama - Birmingham
Birmingham, Alabama, United States
Regents of the University of California San Francisco
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
Columbia University
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas - Houston
Houston, Texas, United States
University of Utah Medical Center
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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