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New treatment option for Pre-Eclampsia
Official title APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia
ClinicalTrials.gov ID: NCT06408181
What this study is testing
What is Aspirin 162 mg?
Aspirin 162 mg is an investigational medicine, being studied as a potential treatment for pre-eclampsia.
Also referred to as acetylsalicylic acid, ASA.
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
- The goal of this clinical trial is to investigate the effects of early initiation of double low-dose aspirin in pregnant women. The main questions it aims to answer are: Does this dose and timing of aspirin reduce the risk of pre-eclampsia compared to standard recommendations?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability to take oral medication and be willing to adhere to the prescribed aspirin regimen.
- Patients with a gestation less than or equal to 6 weeks, 6 days (as determined by patient record of LMP or ART date).
- Patients between 18-45-year old who have one or more risk factors for preeclampsia and/or pregnancy loss, including:
You likely can't join if
- Known allergies to aspirin or non-steroidal anti-inflammatory agents (NSAID);
- Clinical indication for anticoagulant therapy, including prior or current thrombosis, antiphospholipid syndrome, or known major thrombophilia;
- Clinical indication for chronic use of NSAIDS during pregnancy;
- Medical contraindication to aspirin therapy, including untreated uncontrolled asthma, untreated symptomatic nasal polyps, bleeding disorders, or...
- Patients with pelvic pain or bleeding who require urgent care (i.e., active vaginal bleeding greater than or equal to expected menses, open cervical...
See the full eligibility criteria
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Ability to take oral medication and be willing to adhere to the prescribed aspirin regimen.
- Patients with a gestation less than or equal to 6 weeks, 6 days (as determined by patient record of LMP or ART date).
- Patients between 18-45-year old who have one or more risk factors for preeclampsia and/or pregnancy loss, including:
- preeclampsia in a previous pregnancy,
- gestational diabetes in a previous pregnancy,
- any documentation of fetal growth restriction or low birth weight in a prior pregnancy,
- preterm birth in a previous pregnancy,
- known multifetal gestation at enrollment,
- chronic hypertension,
- pregestational diabetes,
- kidney disease,
- systemic lupus erythematosus,
- nulliparity,
- pre-pregnancy body mass index \>30,
- family history of preeclampsia (i.e., mother or sister),
- Black persons (due to social, not biological reasons),
- Maternal age 35 years or older,
- lower income (will be determined by qualification of public health insurance),
- conceived with fertility treatment (including in vitro fertilization, ovulation induction, or intrauterine insemination),
- history of one or more prior pregnancy losses \<20 weeks gestation,
- history of stillbirth in a prior pregnancy,
- An interval of greater than 10 years since the last pregnancy.
- Known allergies to aspirin or non-steroidal anti-inflammatory agents (NSAID);
- Clinical indication for anticoagulant therapy, including prior or current thrombosis, antiphospholipid syndrome, or known major thrombophilia;
- Clinical indication for chronic use of NSAIDS during pregnancy;
- Medical contraindication to aspirin therapy, including untreated uncontrolled asthma, untreated symptomatic nasal polyps, bleeding disorders, or history of gastrointestinal ulcer.
- Patients with pelvic pain or bleeding who require urgent care (i.e., active vaginal bleeding greater than or equal to expected menses, open cervical os suggesting active miscarriage or severe pain requiring evaluation...
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. 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.