Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

Launched by THE GEORGE WASHINGTON UNIVERSITY BIOSTATISTICS CENTER · May 12, 2025

Keywords

ClinConnect Summary

The "Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial" is a study designed to understand if different doses of aspirin can help prevent women who have had a preterm birth (a baby born before 37 weeks of pregnancy) from experiencing another preterm delivery. This trial will involve about 1,800 women who are pregnant with one baby and have a history of giving birth before 35 weeks. Participants will take either a lower dose of 81 mg or a higher dose of 162 mg of aspirin daily, starting between 10 to 15 weeks of pregnancy and continuing until they reach about 36 weeks. The main goal is to see if taking aspirin can lower the chances of having another preterm baby or losing the baby before 35 weeks.

To be eligible for this trial, women need to be at least 14 years old and have had a previous preterm birth due to certain complications. Some women may not qualify if they have specific health conditions, take certain medications, or have had certain types of surgeries. Participants can expect to be monitored throughout the study, and their involvement could contribute valuable information that may help future pregnancies for women at risk of preterm delivery. It's important to note that this trial is not yet recruiting participants, so if you think you might be eligible, keep an eye out for when it begins!

Gender

FEMALE

Eligibility criteria

• 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