Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age14+
SponsorThe George Washington University Biostatistics Center
About this trial
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 aspirin or 81 mg aspirin daily. The study drug will be initiated between 10 and 15 weeks gestation and continued through 36 weeks, 6 days gestation. The primary endpoint is recurrent preterm delivery or fetal death prior to 35 weeks, 0 days gestation.
Eligibility criteria
Qualifiers
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.
Spontaneous preterm birth is defined as spontaneous preterm labor or premature rupture of membranes
Disqualifiers
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
Trial design
Treatments tested in this trial
- 162mg Aspirin
- 81mg Aspirin
Treatment groups
1,800 Participants
are divided into 2 treatment groupsSponsors and collaborators
The George Washington University Biostatistics Center
Lead sponsor
Columbia University
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov