Preterm DeliveryPhase 3ADEPTNCT06980025
Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
A Phase 3 study testing 162mg Aspirin and 81mg Aspirin in people with Preterm Delivery and Obstetrical Complications, run by The George Washington University Biostatistics Center at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery, Obstetrical Complications
- What is being tested?
- 162mg Aspirin and 81mg Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Jul 2025to 28 Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trisha Boekhoudt, MPH contact
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
University of Alabama - Birmingham
Birmingham, Alabama, 35233
Nancy Saxon, RN, BSN, 205-934-1616, nbsaxon@uabmc.edu
Alan TN Tita, MD
- Recruiting
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Kelly Clark, RN, 919-350-6117, kelly_clark@med.unc.edu
John M Thorp, Jr., MD
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Elizabeth Rangel, RN, 312-503-6287, elizabeth.rangel@northwestern.edu
Lynn Yee, MD
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44109
Abigail Pierse, BS, 216-778-8443, apierse@metrohealth.org
Kelly Gibson, MD
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Anna Bartholomew, RN, BSN, 614-685-3229, anna.bartholomew@osumc.edu
Maged Costantine, MD
- Recruiting
Duke University
Durham, North Carolina, 27710
Jennifer Ferrara, RNC MSN, 919-681-6176, jennifer.ferrara@duke.edu
Brenna Hughes, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Christina Reed, RN, NP, 832-826-7377, christina.reed@bcm.edu
Jia Chen, RN, CCRP, 713-798-3798, jia.chen@bcm.edu
- Recruiting
University of Texas - Houston
Houston, Texas, 77030
Felecia Ortiz, RN, 713-500-6467, Felecia.Ortiz@uth.tmc.edu
Hector Mendez-Figueroa, MD
- Recruiting
Columbia University
New York, New York, 10032
Megan Loffredo, MD, CCRC, 203-722-1058, ml4639@cumc.columbia.edu
Uma Reddy, MD
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Christina Pizzi, RN, 267-273-8574, christina.pizzi@pennmedicine.upenn.edu
Samuel Parry, MD
- Recruiting
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
Jeanette Boyce, RN, 412-527-8118, tessje@upmc.edu
Hyagriv Simhan, MD
- Recruiting
Brown University
Providence, Rhode Island, 02905
Angelica DeMartino, RN, BSN, 401-274-1122 ext. 48521, amdemartino@wihri.org
Dwight J Rouse, MD
- Recruiting
University of Utah Medical Center
Salt Lake City, Utah, 84132
Amber Sowles, RN BSN, 801-585-5499, amber.sowles@hsc.utah.edu
Torri Metz, MD
- Recruiting
Regents of the University of California San Francisco
San Francisco, California, 94143
Natalie Oman, MPH, 206-718-4703, natalie.oman@ucsf.edu
Mary Norton, MD
About this study
Official title: A Dose Escalation Study of Low Dose Aspirin for the Prevention of Recurrent Preterm Birth
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.
Read the 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
- Being tested
- 162mg Aspirin, 81mg Aspirin
- Keywords
- Preterm Delivery, Stillbirth, Maternal Morbidity, Neonatal Morbidity, Prevention
- Medical subject headings
- Premature Birth, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
162mg AspirinDrug
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 AspirinDrug
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 group | Role | What they receive |
|---|---|---|
| 162mg Aspirin Daily | Experimental | One 81mg capsule of aspirin daily through 36 weeks 6 days gestation. Receives: Drug: 162mg Aspirin |
| 81mg Aspirin Daily | Experimental | Two 81mg capsules of aspirin daily through 36 weeks 6 days gestation. Receives: Drug: 81mg Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrent preterm delivery or fetal death prior to 35 weeks 0 days gestation
Number and rate of participants who experience a recurrent preterm delivery or fetal death before 35 weeks, 0 days gestation.
Measured: Between randomization and 35 weeks, 0 days gestation (a period of up to 25 weeks)
Secondary outcomes (1)
Rate of ischemic placental disease
Number and rate of participants who experience ischemic placental disease (preeclampsia, small for gestational age <10th percentile, or placental abruption). Small for gestational age is defined by "A 2017 US reference for singleton birth weight percentiles using obstetric estimates of gestation" by Aris et. al (2019).
Measured: Between randomization and delivery (a period of up to 32 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be randomized between 10 weeks, 0 days gestation and 15 weeks, 6 days gestation to either aspirin 162 mg or aspirin 81 mg daily and continue the study intervention through 36 weeks, 6 days gestation. Randomization will be stratified by clinical site.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The George Washington University Biostatistics Center
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Rebecca G Clifton, PhD, Principal investigator, The George Washington University Biostatistics CenterMatthew K Hoffman, MD, MPH, Principal investigator, ChristianaCare Center for Women & Children's Health ResearchUma M Reddy, MD, MPH, Principal investigator, Columbia UniversityCande Ananth, PhD, MPH, Principal investigator, Robert Wood Johnson Medical School - Rutgers Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980025
- Sponsor's protocol ID
- HD109332-ADEPT
- Other IDs
- U01HD109332, U24HD036801
- Acronym
- ADEPT
- Status last verified
- Apr 2026
- First submitted
- 12 May 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared via NICHD DASH in accordance with NIH policy.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Escalation Study of Low Dose Aspirin for the Prevention of Recurrent Preterm Birth
- ClinicalTrials.gov ID
- NCT06980025
- Acronym / sponsor ID
- ADEPT / HD109332-ADEPT
- Conditions
- Preterm Delivery, Obstetrical Complications
- Keywords
- Preterm Delivery, Stillbirth, Maternal Morbidity, Neonatal Morbidity, Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- The George Washington University Biostatistics CenterUniversity, hospital or other
- Collaborators
- Columbia University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals will be randomized between 10 weeks, 0 days gestation and 15 weeks, 6 days gestation to either aspirin 162 mg or aspirin 81 mg daily and continue the study intervention through 36 weeks, 6 days gestation. Randomization will be stratified by clinical site.
| Arm | Type | Receives |
|---|---|---|
| 162mg Aspirin Daily | Experimental | Drug: 162mg AspirinOne 81mg capsule of aspirin daily through 36 weeks 6 days gestation. |
| 81mg Aspirin Daily | Experimental | Drug: 81mg AspirinTwo 81mg capsules of aspirin daily through 36 weeks 6 days gestation. |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 162mg AspirinTwo 81mg aspirin tablets in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle). | Drug | 162mg Aspirin Daily |
| 81mg AspirinOne 81mg aspirin tablet in an over-encapsulated capsule filled with microcrystalline cellulose. Study intervention will be packaged into bottles (35 capsules per bottle). | Drug | 81mg Aspirin Daily |
Primary outcome
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)
Number and rate of participants who experience a recurrent preterm delivery or fetal death before 35 weeks, 0 days gestation.
1 secondary outcome
Rate of ischemic placental disease
Time frame: Between randomization and delivery (a period of up to 32 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. Data will be shared via NICHD DASH in accordance with NIH policy.
Related trials for Preterm Delivery
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trisha Boekhoudt, MPH contact
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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 162mg Aspirin and 81mg Aspirin in people with Preterm Delivery and Obstetrical Complications, run by The George Washington University Biostatistics Center at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca G Clifton, PhD ((301) 881-9260, rclifton@bsc.gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.