Aspirin for Preterm Birth

(ADEPT Trial)

Recruiting at 13 trial locations

Overseen By Trisha Boekhoudt, MPH

Age: Any Age

Sex: Female

Trial Phase: Phase 3

Sponsor: The George Washington University Biostatistics Center

Must not be taking: Anticoagulants, Glucocorticoids

Disqualifiers: Hypertension, Renal disease, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 22-27 weeks

1800 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Rebecca G Clifton, PhD

Principal Investigator

The George Washington University Biostatistics Center

Uma M Reddy, MD, MPH

Principal Investigator

Columbia University

Cande Ananth, PhD, MPH

Principal Investigator

Robert Wood Johnson Medical School - Rutgers Health

Matthew K Hoffman, MD, MPH

Principal Investigator

ChristianaCare Center for Women & Children's Health Research

Eligibility Criteria

This trial is for individuals who have had a baby born prematurely (before 35 weeks of pregnancy) and are currently between 10 to 15 weeks pregnant. They must be willing to take aspirin daily until about the end of their third trimester.

Inclusion Criteria

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.

I am 14 years old or older.

Gestational age at randomization between 10 weeks 0 days and 15 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.

Exclusion Criteria

I am taking more than 81 mg of aspirin daily during my pregnancy and cannot stop for 2 weeks.

I am allergic to aspirin or have a condition that makes it unsafe for me.

Delivery planned at a non-participating site

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either 162 mg or 81 mg of aspirin daily from 10-15 weeks gestation through 36 weeks, 6 days gestation

22-27 weeks

Monthly virtual or in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Aspirin

Trial Overview The study compares two doses of aspirin, one group taking a lower dose (81mg) and another taking a higher dose (162mg), to see which is more effective at preventing preterm birth or fetal death before reaching full term.

Participant Groups

Group I: 81mg Aspirin Daily Experimental Treatment 1 Intervention

Two 81mg capsules of aspirin daily through 36 weeks 6 days gestation.

Group II: 162mg Aspirin Daily Experimental Treatment 1 Intervention

One 81mg capsule of aspirin daily through 36 weeks 6 days gestation.

Who Is Running the Clinical Trial?

The George Washington University Biostatistics Center

Lead Sponsor

Trials

27

Recruited

111,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+