Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

Recruiting Phase 3 Interventional Study
Preterm Delivery Obstetrical Complications
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
14 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
1,800 (estimated)
Sponsor
The George Washington University Biostatistics Center · Other
Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
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 o…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * 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 n…
Contacts

Rebecca G Clifton, PhD

(301) 881-9260

rclifton@bsc.gwu.edu

CONTACT

Trisha Boekhoudt, MPH

trishab@bsc.gwu.edu

CONTACT