Aspirin for Preterm Birth

(ADEPT Trial)

Recruiting at 14 trial locations

Overseen By Trisha Boekhoudt, MPH

Age: Any Age

Sex: Female

Trial Phase: Phase 3

Sponsor: The George Washington University Biostatistics Center

Must not be taking: Anticoagulants, Glucocorticoids

Disqualifiers: Hypertension, Renal disease, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 22-27 weeks

1800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether aspirin can help prevent preterm births in individuals with a history of early birth. Participants will be randomly assigned to take either a higher dose (162 mg) or a lower dose (81 mg) of aspirin daily. The trial aims to determine if one dose more effectively reduces the risk of giving birth before 35 weeks or experiencing fetal death. Those who may qualify include individuals who have had a spontaneous early birth or placental issues in a previous pregnancy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

If you are taking more than 81 mg of aspirin daily during your current pregnancy, you will need to stop for a 2-week period before joining the trial. If you are on other anticoagulants like Heparin, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that low-dose aspirin is generally safe for pregnant women. Studies have found that taking low doses of aspirin can reduce the risk of preterm birth. For example, one study found that women who took 100 mg of aspirin daily had a lower chance of giving birth before 37 weeks. Another study suggested that aspirin can decrease the risk of pregnancy-related health problems that might lead to early delivery.

While aspirin is commonly used and considered safe in low doses, individual reactions can vary. Many people tolerate it well, but some might experience mild side effects like an upset stomach or heartburn. It is important to consult a healthcare provider about any concerns before starting treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for preventing preterm birth focus on interventions like progesterone supplementation or lifestyle modifications. But researchers are excited about using aspirin in this context because it might reduce inflammation and improve blood flow to the placenta, potentially lowering the risk of preterm labor. The trial explores two experimental doses: 81mg and 162mg daily. This dual approach allows researchers to pinpoint the most effective dose, which is different from the typical single-dose strategies used in other treatments.

What evidence suggests that aspirin might be an effective treatment for preterm birth?

Studies have shown that low-dose aspirin can reduce the risk of preterm birth. One study found that taking 100 mg of aspirin daily before the 16th week of pregnancy reduced the chance of early birth by more than half. Another analysis revealed that aspirin use significantly lowered the risk of early births and perinatal deaths. Although some research indicates a smaller reduction, the overall evidence suggests aspirin can be beneficial. The ongoing trial compares two doses of aspirin—162 mg daily and 81 mg daily—to determine which is more effective at preventing early births. ^{3 5 6 7 8}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for individuals who have had a baby born prematurely (before 35 weeks of pregnancy) and are currently between 10 to 15 weeks pregnant. They must be willing to take aspirin daily until about the end of their third trimester.

Inclusion Criteria

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.

I am 14 years old or older.

Gestational age at randomization between 10 weeks 0 days and 15 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.

Exclusion Criteria

I am taking more than 81 mg of aspirin daily during my pregnancy and cannot stop for 2 weeks.

Delivery planned at a non-participating site

I am allergic to aspirin or have a condition that makes it unsafe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either 162 mg or 81 mg of aspirin daily from 10-15 weeks gestation through 36 weeks, 6 days gestation

22-27 weeks

Monthly virtual or in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin

Trial Overview The study compares two doses of aspirin, one group taking a lower dose (81mg) and another taking a higher dose (162mg), to see which is more effective at preventing preterm birth or fetal death before reaching full term.

How Is the Trial Designed?

Group I: 81mg Aspirin Daily Experimental Treatment 1 Intervention

Two 81mg capsules of aspirin daily through 36 weeks 6 days gestation.

Group II: 162mg Aspirin Daily Experimental Treatment 1 Intervention

One 81mg capsule of aspirin daily through 36 weeks 6 days gestation.

Who Is Running the Clinical Trial?

The George Washington University Biostatistics Center

Lead Sponsor

Trials

27

Recruited

111,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39606899/

Cost-effectiveness of a randomized controlled trial ... We observed a small, statistically non-significant difference in preterm birth (21.2% vs. 25.4%; risk difference -4.3%; 95% CI: -12.7% to 4.1%) and healthcare ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933324003215

Low-dose aspirin use in low-risk nulliparous pregnancies Patients who took 100 mg daily of aspirin prior to 16 weeks had a significantly lower risk of preterm birth at less than 37 weeks (RR: 0.45, 95% CI: 0.35−0.59), ...

3. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/counter/pdf/10.1186/s12884-017-1338-0.pdf?utm_source=consensus

Low dose aspirin in the prevention of recurrent spontaneous ... We will assess the (cost-)effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized ...

4. karger.com karger.com/goi/article/doi/10.1159/000546964/930835/Low-Dose-Aspirin-and-Prevention-of-Spontaneous

Low-Dose Aspirin and Prevention of Spontaneous Preterm ... This meta-analysis showed a non-significant reduction of any spontaneous PTB rates associated with LDA administration. Statistical significance ...

5. mdpi.com mdpi.com/2673-3897/6/2/8

Low-Dose Aspirin for Preterm Birth Prevention in Low Low-dose aspirin therapy significantly lowered the risks of preterm births (RR 0.91, 95% CI 0.84–0.98, p = 0.02) and perinatal mortality (RR 0.83, 95% CI

6. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2018/07/low-dose-aspirin-use-during-pregnancy

Low-Dose Aspirin Use During Pregnancy In that study, treatment with low-dose aspirin resulted in a 7% reduction in the risk of spontaneous preterm birth at fewer than 37 weeks (RR, 0.93; 95% CI, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6152923/

Low-Dose Aspirin and Preterm Birth: A Randomized ... Low-dose aspirin also has the potential to decrease the risk for medically indicated preterm births by lowering the chances of developing preeclampsia or fetal ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02409680

Aspirin Supplementation for Pregnancy Indicated Risk ... Available data suggest that low dose aspirin may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm ...