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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD112308-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double low-dose aspirin | Active Comparator | Participants will take 2 81mg aspirin tablets daily from entrance into the trial until delivery. |
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| Standard of Care | Placebo Comparator | Participants will take 2 placebo pills from entrance into the study until 12 weeks gestational age, they will then take 1 placebo pill and 1 81mg aspirin until delivery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin 162 mg | Drug | Aspirin is a nonsteroidal anti-inflammatory drug. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pregnancy Loss | Pregnancy loss prior to 24 weeks gestation | from enrollment to time of pregnancy loss, up to 24 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion 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:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kurt T Barnhart, MD | Contact | 215-662-2974 | kbarnhart@pennmedicine.upenn.edu | |
| Enrique Schisterman, PhD | Contact | enrique.schisterman@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Enrique Schisterman, PhD | University of Pennsylvania | Principal Investigator |
| Kurt Barnhart, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin 81mg | Drug | Aspirin is a nonsteroidal anti-inflammatory drug. |
|
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| 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 |
| Term preeclampsia | Diagnosis of term preeclampsia, occurring at 37 weeks or later in pregnancy | From 37 weeks until delivery, up to 3 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| Clinical pregnancy loss | Defined as any pregnancy loss occurring following ultrasound confirmation of pregnancy | From time of first ultrasound to 20 weeks pregnancy |
| Preterm birth | Defined as delivery at less than 37 weeks gestation | From enrollment to 36 weeks 6 days of pregnancy, up to delivery |
| Small for gestational age | Defined as a birth weight less than 10th percentile for gestational age | At time of delivery |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |