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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06408181
Other study ID # 854886
Secondary ID 1R01HD112308-01
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 12, 2024
Est. completion date June 2029

Study information

Verified date June 2024
Source University of Pennsylvania
Contact Kurt T Barnhart, MD
Phone 215-662-2974
Email kbarnhart@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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? Does this dose and timing of aspirin reduce the risk of pregnancy loss compared to standard recommendations? Participants will begin taking at no later than 6 weeks 6 days gestational age, either 162mg of aspirin through delivery or placebo until 12 weeks and then 81mg of aspirin through delivery.


Recruitment information / eligibility

Status Recruiting
Enrollment 1150
Est. completion date June 2029
Est. primary completion date June 2029
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Ability to take oral medication and be willing to adhere to the prescribed aspirin regimen. 4. Patients with a gestation less than or equal to 6 weeks, 6 days (as determined by patient record of LMP or ART date). 5. Patients between 18-45-year old who have one or more risk factors for preeclampsia and/or pregnancy loss, including: 1. preeclampsia in a previous pregnancy, 2. gestational diabetes in a previous pregnancy, 3. any documentation of fetal growth restriction or low birth weight in a prior pregnancy, 4. preterm birth in a previous pregnancy, 5. known multifetal gestation at enrollment, 6. chronic hypertension, 7. pregestational diabetes, 8. kidney disease, 9. systemic lupus erythematosus, 10. nulliparity, 11. pre-pregnancy body mass index >30, 12. family history of preeclampsia (i.e., mother or sister), 13. Black persons (due to social, not biological reasons), 14. Maternal age 35 years or older, 15. lower income (will be determined by qualification of public health insurance), 16. conceived with fertility treatment (including in vitro fertilization, ovulation induction, or intrauterine insemination), 17. history of one or more prior pregnancy losses <20 weeks gestation, 18. history of stillbirth in a prior pregnancy, 19. An interval of greater than 10 years since the last pregnancy. Exclusion Criteria 1. Known allergies to aspirin or non-steroidal anti-inflammatory agents (NSAID); 2. Clinical indication for anticoagulant therapy, including prior or current thrombosis, antiphospholipid syndrome, or known major thrombophilia; 3. Clinical indication for chronic use of NSAIDS during pregnancy; 4. Medical contraindication to aspirin therapy, including uncontrolled asthma, nasal polyps, bleeding disorders, or history of gastrointestinal ulcer. 5. 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 for ectopic pregnancy)

Study Design


Intervention

Drug:
Aspirin 162 mg
Aspirin is a nonsteroidal anti-inflammatory drug.
Aspirin 81mg
Aspirin is a nonsteroidal anti-inflammatory drug.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preeclampsia with or without severe features defined as two blood pressures (BPs) = 140/90 mmHg at least 4 hours apart with proteinuria from 20 weeks pregnancy to delivery, approximately 20 weeks
Primary Pregnancy Loss Pregnancy loss prior to 24 weeks gestation from enrollment to time of pregnancy loss, up to 24 weeks gestation
Secondary Composite outcome of hypertensive disorders of pregnancy or pregnancy loss This composite outcome will include the diagnosis of any of the following: preterm preeclampsia, term preeclampsia, gestational hypertension, preeclampsia with severe features, preeclampsia without severe features, biochemical pregnancy loss, clinical pregnancy loss From enrollment to end of pregnancy, up to 38 weeks
Secondary Preterm preeclampsia Diagnosis of preterm preeclampsia, occurring prior to 37 weeks in pregnancy From enrollment up to 37 weeks of pregnancy, up to 37 weeks of pregnancy
Secondary Term preeclampsia Diagnosis of term preeclampsia, occurring at 37 weeks or later in pregnancy From 37 weeks until delivery, up to 3 weeks
Secondary Gestational Hypertension Defined as two BPs = 140/90 mmHg at least 4 hours apart without proteinuria From 20 weeks of pregnancy to delivery, approximately 20 weeks
Secondary Preeclampsia with severe features Diagnosis of preeclampsia with severe hypertension and/or specific signs or symptoms of significant end-organ dysfunction From 20 weeks of pregnancy to delivery, up to 20 weeks
Secondary Preeclampsia without severe features defined as two BPs =160/110 mmHg at least 4 hours apart or any of the following lab abnormalities or symptoms: platelets <100,000/microliter, liver enzymes at least twice the normal concentration, and/or severe right upper quadrant/epigastric pain, serum creatinine > 1.1 mg/dL or a doubling of baseline serum creatinine, pulmonary edema, or new-onset cerebral or visual disturbances (headache, blurry vision). Preeclampsia super-imposed on chronic hypertension will also be considered as part of this outcome. From 20 weeks of pregnancy to delivery, up to 20 weeks
Secondary Biochemical pregnancy loss Defined as losses that occur prior to identification of a gestational sac via ultrasound From enrollment to time of pregnancy loss, up to approximately 20 weeks
Secondary Clinical pregnancy loss Defined as any pregnancy loss occurring following ultrasound confirmation of pregnancy From time of first ultrasound to 20 weeks pregnancy
Secondary Preterm birth Defined as delivery at less than 37 weeks gestation From enrollment to 36 weeks 6 days of pregnancy, up to delivery
Secondary Small for gestational age Defined as a birth weight less than 10th percentile for gestational age At time of delivery
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