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.
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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,800
Two 81mg aspirin tablets in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).
One 81mg aspirin tablet in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).
University of Alabama - Birmingham
Birmingham, Alabama, United States
RECRUITINGRegents of the University of California San Francisco
San Francisco, California, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
RECRUITINGColumbia University
New York, New York, United States
RECRUITINGUniversity of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGCase Western Reserve University
Cleveland, Ohio, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGMagee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States
RECRUITING...and 4 more locations
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)
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)
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