BridgeMD
Prevention study for Preterm Delivery
Official title Aspirin Dose Escalation for the Prevention of Recurrent Preterm Delivery Trial
ClinicalTrials.gov ID: NCT06980025
What this study is testing
What is 162mg Aspirin?
162mg Aspirin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for preterm delivery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 14 years or older
- Singleton gestation. Twin gestation reduced to a singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred...
- 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
You likely can't join if
- Known allergy or hypersensitivity to aspirin or any medical condition where aspirin is contraindicated (e.g., history of peptic ulcer disease, nasal...
- 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...
See the full eligibility 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...
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 14 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; San Francisco, California, United States; Chicago, Illinois, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Durham, North Carolina, United States and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.