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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
162mg Aspirin
DrugTwo 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
DrugOne 81mg aspirin tablet in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).
Treatment groups
1,800 Participants
are divided into 2 treatment groupsGroup A: 162mg Aspirin DailyExperimental treatment 1 intervention
Group B: 81mg Aspirin DailyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of recurrent preterm delivery or fetal death prior to 35 weeks 0 days gestation
Number and rate of participants who experience a recurrent preterm delivery or fetal death before 35 weeks, 0 days gestation.
Time frame
Between randomization and 35 weeks, 0 days gestation (a period of up to 25 weeks)Secondary outcomes
1
Rate of ischemic placental disease
Number and rate of participants who experience ischemic placental disease (preeclampsia, small for gestational age \<10th percentile, or placental abruption). Small for gestational age is defined by "A 2017 US reference for singleton birth weight percentiles using obstetric estimates of gestation" by Aris et. al (2019).
Time frame
Between randomization and delivery (a period of up to 32 weeks)Other outcomes
1
Rate of recurrent preterm delivery or fetal death at <28 weeks
Number and rate of participants who experience a recurrent preterm delivery or fetal death at less than 28 weeks
Time frame
Between randomization and delivery (a period of up to 18 weeks)2
Rate of recurrent preterm delivery or fetal death at <37 weeks
Number and rate of participants who experience a recurrent preterm delivery or fetal death at less than 37 weeks
Time frame
Between randomization and delivery (a period of up to 27 weeks)3
Rate of ischemic placental disease with delivery prior to 28 weeks
Number and rate of participants who experience ischemic placental disease (preeclampsia, fetal growth restriction, or placental abruption) with delivery before 28 weeks gestation
Time frame
Between randomization and delivery (a period of up to 18 weeks)4
Rate of ischemic placental disease with delivery prior to 35 weeks
Number and rate of participants who experience ischemic placental disease (preeclampsia, fetal growth restriction, or placental abruption) with delivery before 35 weeks gestation
Time frame
Between randomization and delivery (a period of up to 25 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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