RECRUITING

Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial

Conditions

Preterm Delivery Obstetrical Complications Stillbirth Maternal Morbidity Neonatal Morbidity Prevention

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

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

Quick Facts

Study Start:2025-06-10

Study Completion:2029-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06980025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 not eligible. * Gestational age at randomization between 10 weeks 0 days and 15 weeks 6 days based on clinical information and evaluation of the earliest ultrasound. * Prior preterm birth between 20 weeks 0 days and 34 weeks 6 days with one of the following in the proximal birth reaching 20 weeks or greater: * Spontaneous preterm birth is defined as spontaneous preterm labor or premature rupture of membranes * Ischemic placental disease is defined as preeclampsia, small for gestational age, fetal growth restriction, or placental abruption, as defined clinically. * Stillbirth excluding those with known genetic disorders or major congenital anomalies.	* Known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., history of peptic ulcer disease, nasal polyps, NSAID-induced asthma, history of gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders, and consumption of 3 or more alcoholic drinks per day) * Taking other anticoagulants such as Heparin or Low-Molecular weight Heparin * Thrombocytopenia defined as a platelet count defined as a platelet count \<100,000 microliters * Gastric bypass surgery, regardless of type * Aspirin use \>81 mg daily during the current pregnancy who are not willing or able to go through a 2-week washout before randomization. * Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery. * Known fetal genetic disease or major malformations * Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from twins to singleton, is not an exclusion. * Any fetal/maternal condition requiring invasive in-utero assessment or treatment, for example, significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia. * Patients with any of the following medical conditions because of increased risk for adverse pregnancy outcome or indicated preterm birth: * Treated hypertension requiring more than one agent * Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL * Conditions treated with chronic oral glucocorticoid therapy (e.g., systemic lupus erythematosus) * Uncontrolled hyper- and hypothyroid disease * New York Heart Association (NYHA) stage II or greater cardiac disease * Planned indicated delivery prior to 37 weeks. * Participation in another interventional study that influences the primary outcome in this study (gestational age at delivery). * Participation in this trial in a previous pregnancy. * Delivery planned at a non-participating site

Inclusion Criteria

Exclusion 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 not eligible.
* Gestational age at randomization between 10 weeks 0 days and 15 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.
* Prior preterm birth between 20 weeks 0 days and 34 weeks 6 days with one of the following in the proximal birth reaching 20 weeks or greater:
* Spontaneous preterm birth is defined as spontaneous preterm labor or premature rupture of membranes
* Ischemic placental disease is defined as preeclampsia, small for gestational age, fetal growth restriction, or placental abruption, as defined clinically.
* Stillbirth excluding those with known genetic disorders or major congenital anomalies.

* Known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., history of peptic ulcer disease, nasal polyps, NSAID-induced asthma, history of gastrointestinal bleeding, known G6PD deficiency, severe hepatic dysfunction, bleeding disorders, and consumption of 3 or more alcoholic drinks per day)
* Taking other anticoagulants such as Heparin or Low-Molecular weight Heparin
* Thrombocytopenia defined as a platelet count defined as a platelet count \<100,000 microliters
* Gastric bypass surgery, regardless of type
* Aspirin use \>81 mg daily during the current pregnancy who are not willing or able to go through a 2-week washout before randomization.
* Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery.
* Known fetal genetic disease or major malformations
* Fetal demise or planned termination of pregnancy. Selective reduction by 13 weeks 6 days gestation, from twins to singleton, is not an exclusion.
* Any fetal/maternal condition requiring invasive in-utero assessment or treatment, for example, significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia.
* Patients with any of the following medical conditions because of increased risk for adverse pregnancy outcome or indicated preterm birth:
* Treated hypertension requiring more than one agent
* Chronic renal disease with baseline serum creatinine ≥1.5 mg/dL
* Conditions treated with chronic oral glucocorticoid therapy (e.g., systemic lupus erythematosus)
* Uncontrolled hyper- and hypothyroid disease
* New York Heart Association (NYHA) stage II or greater cardiac disease
* Planned indicated delivery prior to 37 weeks.
* Participation in another interventional study that influences the primary outcome in this study (gestational age at delivery).
* Participation in this trial in a previous pregnancy.
* Delivery planned at a non-participating site

Contacts and Locations

Study Contact

Rebecca G Clifton, PhD

CONTACT

301-881-9260

rclifton@bsc.gwu.edu

Trisha Boekhoudt, MPH

CONTACT

trishab@bsc.gwu.edu

Principal Investigator

Rebecca G Clifton, PhD

PRINCIPAL_INVESTIGATOR

The George Washington University Biostatistics Center

Matthew K Hoffman, MD, MPH

PRINCIPAL_INVESTIGATOR

ChristianaCare Center for Women & Children's Health Research

Uma M Reddy, MD, MPH

PRINCIPAL_INVESTIGATOR

Columbia University

Cande Ananth, PhD, MPH

PRINCIPAL_INVESTIGATOR

Robert Wood Johnson Medical School - Rutgers Health

Study Locations (Sites)

University of Alabama - Birmingham

Birmingham, Alabama, 35233

United States

Regents of the University of California San Francisco

San Francisco, California, 94143

United States

Northwestern University

Chicago, Illinois, 60611

United States

Columbia University

New York, New York, 10032

United States

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Duke University

Durham, North Carolina, 27710

United States

Case Western Reserve University

Cleveland, Ohio, 44109

United States

Ohio State University

Columbus, Ohio, 43210

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213

United States

Brown Univeristy

Providence, Rhode Island, 02905

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

University of Texas - Houston

Houston, Texas, 77030

United States

University of Utah Medical Center

Salt Lake City, Utah, 84132

United States

Collaborators and Investigators

Sponsor: The George Washington University Biostatistics Center

Rebecca G Clifton, PhD, PRINCIPAL_INVESTIGATOR, The George Washington University Biostatistics Center
Matthew K Hoffman, MD, MPH, PRINCIPAL_INVESTIGATOR, ChristianaCare Center for Women & Children's Health Research
Uma M Reddy, MD, MPH, PRINCIPAL_INVESTIGATOR, Columbia University
Cande Ananth, PhD, MPH, PRINCIPAL_INVESTIGATOR, Robert Wood Johnson Medical School - Rutgers Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-10

Study Completion Date2029-02-28

Study Record Updates

Study Start Date2025-06-10

Study Completion Date2029-02-28

Terms related to this study

Keywords Provided by Researchers

Preterm Delivery
Stillbirth
Maternal Morbidity
Neonatal Morbidity
Prevention

Additional Relevant MeSH Terms

Preterm Delivery
Obstetrical Complications