Higher-dose versus standard-dose aspirin to prevent another early preterm birth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III, multicenter, double-blind randomized trial will enroll 1,800 pregnant individuals with a prior preterm birth before 35 weeks and randomize them to 162 mg or 81 mg of aspirin daily. Study drug is started between 10 and 15 weeks gestation and continued through 36 weeks, 6 days, with participants and staff blinded to dose. The primary outcome is recurrent preterm delivery or fetal death before 35 weeks, while secondary outcomes include ischemic placental disease and other maternal and neonatal complications. Safety data and exploratory subgroup analyses will be collected across several U.S. academic centers.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama - Birmingham
  Birmingham, Alabama, United States Recruiting
• Regents of the University of California San Francisco
  San Francisco, California, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting
• University of North Carolina - Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Rebecca G Clifton, PhD — The George Washington University Biostatistics Center
• Study coordinator: Rebecca G Clifton, PhD
• Email: rclifton@bsc.gwu.edu
• Phone: (301) 881-9260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.