Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
The George Washington University Biostatistics Center
Study ID
NCT06980025
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Obstetrical Complications
  • Preterm Delivery

Eligibility Criteria

Sex
FEMALE
Age
14 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
1,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 162mg Aspirin Daily
    One 81mg capsule of aspirin daily through 36 weeks 6 days gestation.
  • Experimental: 81mg Aspirin Daily
    Two 81mg capsules of aspirin daily through 36 weeks 6 days gestation.

Primary Outcome Measure

Rate of recurrent preterm delivery or fetal death prior to 35 weeks 0 days gestation [ Time Frame: Between randomization and 35 weeks, 0 days gestation (a period of up to 25 weeks) ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama - BirminghamBirminghamAlabama35233
Nancy Saxon, RN, BSN
[email protected]
205-934-1616
Alan TN Tita, MD (PRINCIPAL_INVESTIGATOR)
Regents of the University of California San FranciscoSan FranciscoCalifornia94143
Natalie Oman, MPH
[email protected]
206-718-4703
Mary Norton, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Elizabeth Rangel, RN
[email protected]
312-503-6287
Lynn Yee, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Megan Loffredo, MD, CCRC
[email protected]
203-722-1058
Uma Reddy, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina - Chapel HillChapel HillNorth Carolina27599
Kelly Clark, RN
[email protected]
919-350-6117
John M Thorp, Jr., MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Jennifer Ferrara, RNC MSN
[email protected]
919-681-6176
Brenna Hughes, MD (PRINCIPAL_INVESTIGATOR)
Case Western Reserve UniversityClevelandOhio44109
Abigail Pierse, BS
[email protected]
216-778-8443
Kelly Gibson, MD (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Anna Bartholomew, RN, BSN
[email protected]
614-685-3229
Maged Costantine, MD (PRINCIPAL_INVESTIGATOR)
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Christina Pizzi, RN
[email protected]
267-273-8574
Samuel Parry, MD (PRINCIPAL_INVESTIGATOR)
Magee Women's Hospital of UPMCPittsburghPennsylvania15213
Jeanette Boyce, RN
[email protected]
412-527-8118
Hyagriv Simhan, MD (PRINCIPAL_INVESTIGATOR)
Brown UniversityProvidenceRhode Island02905
Angelica DeMartino, RN, BSN
[email protected]
401-274-1122
Dwight J Rouse, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Christina Reed, RN, NP
[email protected]
832-826-7377
Jia Chen, RN, CCRP
[email protected]
713-798-3798
Catherine Eppes, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of Texas - HoustonHoustonTexas77030
Felecia Ortiz, RN
[email protected]
713-500-6467
Hector Mendez-Figueroa, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Medical CenterSalt Lake CityUtah84132
Amber Sowles, RN BSN
[email protected]
801-585-5499
Torri Metz, MD (PRINCIPAL_INVESTIGATOR)

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