NCT06980025

Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

A Dose Escalation Study of Low Dose Aspirin for the Prevention of Recurrent Preterm Birth

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (estimated)
• Sponsor: The George Washington University Biostatistics Center · Academic / Other
• Sex: Female
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Preterm Delivery
• Obstetrical Complications

Interventions

Type	Name	Description
DRUG	162mg Aspirin	Two 81mg aspirin tablets in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).
DRUG	81mg Aspirin	One 81mg aspirin tablet in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle).

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-12-31
• Completion: 2029-02-28
• First posted: 2025-05-20
• Last updated: 2026-04-09

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study