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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL168356 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The objective of this research project is to conduct a single-site pilot trial to assess the feasibility and effect of low-dose aspirin to augment vascular recovery in the immediate postpartum period after preeclampsia through two specific aims: 1) to pilot test the feasibility of conducting a randomized controlled trial of postpartum low dose aspirin vs. placebo, and 2) to assess the effect of postpartum aspirin on endothelial function and blood pressure. Our central hypothesis is that postpartum administration of low-dose aspirin following preeclampsia will be feasible, improve endothelial function, and lower BP at 6 months postpartum. Subjects will undergo 3 study visits involving BP measurements, blood draws, questionnaires, and/or microiontophoresis. Up to 60 adult subjects will be enrolled at Magee-Women's Hospital.
This is a pilot randomized, single-center, double-blind placebo-control study of low dose aspirin in postpartum individuals with preeclampsia. Individuals will be randomized at the time of delivery 1:1 to 81mg of low-dose aspirin or identical appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two study visits. At each study visit, participants will undergo a blood draw, blood pressure measurement and assessment of endothelial function with microiontophoresis. Participant adherence will be monitored through pill counts, text message check-ins, patient diary and biochemical monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Similar appearing placebo pill daily for 6 months will be given to subjects. |
|
| Intervention Group | Experimental | Low-dose [81 mg] aspirin pill daily for 6 months will be given to subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose aspirin | Drug | The intervention group will receive low-dose [81 mg] aspirin pill daily for 6 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of participants eligible, enrolled and retained (feasibility) | To determine the feasibility of conducting a single-site randomized controlled trial of 6 months of postpartum low-dose aspirin vs. placebo in women with preeclampsia. | Baseline to approximately 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Study visit systolic BP | Mean study visit systolic BP | 2 months postpartum |
| Study visit diastolic BP | Mean study visit diastolic BP | 2 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alisse K Hauspurg, MD | Contact | 412-641-1381 | janickia@upmc.edu | |
| Sila Yavan, MS | Contact | 4124174981 | yavans@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alisse K Hauspurg, MD | UPMC Magee Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Magee-Womens Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
Deidentified data (including data dictionaries) will be shared at the discretion of the primary investigator. Data will include blood pressure, weight, demographics, physical activity, and pregnancy related information. Additional documents (such as the study protocol) will be made available.
Within a year after outcomes are published and no later than 3 years after the end of clinical activities.
NHLBI data repository request process
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This is a pilot randomized, single-center, double-blind placebo-control study of low-dose aspirin in postpartum individuals with preeclampsia. Individuals will be randomized at the time of delivery 1:1 to 81mg of low-dose aspirin or similar-appearing placebo daily for six months postpartum. Treatment and control groups will monitor home blood pressure throughout the study period and undergo two additional study visits. At each study visit, participants will undergo a blood draw, blood pressure measurement and assessment of endothelial function with microiontophoresis. Participant adherence will be monitored through pill counts, text message check-ins, patient diary and biochemical monitoring.
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Participants, Investigators and outcomes assessors will be blinded.
| Placebo | Drug | The control group will receive similar appearing placebo daily for 6 months. |
|
| Study visit systolic BP | Mean study visit systolic BP | 6 months postpartum |
| Study visit diastolic BP | Mean study visit diastolic BP | 6 months postpartum |
| Study visit mean arterial pressure | Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3)) | 2 months postpartum |
| Study visit mean arterial pressure | Mean study visit mean arterial pressure ((2*diastolic BP + systolic BP / 3)) | 6 months postpartum |
| Anti-hypertensive medication use | Use of anti-hypertensive medication (percent of participants) | 2 months postpartum |
| Anti-hypertensive medication use | Use of anti-hypertensive medication (percent of participants) | 6 months postpartum |
| Therapeutic intensity score | Therapeutic intensity score for those on anti-hypertensive medications. Range of scores 0 to 5 (higher number indicates higher doses and number of anti-hypertensive medications; worse outcome) | 2 months postpartum |
| Therapeutic intensity score | Therapeutic intensity score for those on anti-hypertensive medications. Range of scores 0 to 5 (higher number indicates higher doses and number of anti-hypertensive medications; worse outcome) | 6 months postpartum |
| Mean home systolic blood pressure | Mean home systolic blood pressure | delivery through 6 months postpartum |
| Mean home diastolic blood pressure | Mean home diastolic blood pressure | delivery through 6 months postpartum |
| Mean home mean arterial pressure | Mean home mean arterial pressure | delivery through 6 months postpartum |
| Mean daytime systolic blood pressure | Mean daytime systolic blood pressure on ambulatory blood pressure monitoring | 6 months postpartum |
| Mean nocturnal systolic blood pressure | Mean nocturnal systolic blood pressure on ambulatory blood pressure monitoring | 6 months postpartum |
| Mean daytime diastolic blood pressure | Mean daytime diastolic blood pressure on ambulatory blood pressure monitoring | 6 months postpartum |
| Mean nocturnal diastolic blood pressure | Mean nocturnal diastolic blood pressure on ambulatory blood pressure monitoring | 6 months postpartum |
| Mean nocturnal mean arterial pressure | Mean nocturnal mean arterial pressure on ambulatory blood pressure monitoring | 6 months postpartum |
| Mean daytime mean arterial pressure | Mean daytime mean arterial pressure on ambulatory blood pressure monitoring | 6 months postpartum |
| Mean overall mean arterial pressure | Mean overall mean arterial pressure on ambulatory blood pressure monitoring | 6 months postpartum |
| Mean overall systolic blood pressure | Mean overall systolic blood pressure on ambulatory blood pressure monitoring | 6 months postpartum |
| Mean overall diastolic blood pressure | Mean overall diastolic blood pressure on ambulatory blood pressure monitoring | 6 months postpartum |
| Classification of hypertension | Stage 1, stage 2 hypertension (percent of participants with each stage) | 2 months postpartum |
| Classification of hypertension | Stage 1, stage 2 hypertension (percent of participants with each stage) | 6 months postpartum |
| Endothelial function EC50% | EC50% from microiontophoresis | 2 months postpartum |
| Endothelial function EC50% | EC50% from microiontophoresis | 6 months postpartum |
| Endothelial function Emax | Emax from microiontophoresis | 2 months postpartum |
| Endothelial function Emax | Emax from microiontophoresis | 6 months postpartum |
| Endothelial function change in Emax | Change in Emax between visits | 2 to 6 months postpartum |
| Endothelial function change in EC50% | Change in EC50% between visits | 2 to 6 months postpartum |
| Change in systolic blood pressure | Change in study visit mean systolic blood pressure between visits | 2 to 6 months postpartum |
| Change in diastolic blood pressure | Change in study visit mean diastolic blood pressure between visits | 2 to 6 months postpartum |
| Change in mean arterial pressure | Change in study visit mean arterial pressure between visits | 2 to 6 months postpartum |
| ID | Term |
|---|---|
| D014115 | Toxemia |
| D011225 | Pre-Eclampsia |
| D006973 | Hypertension |
| D004461 | Eclampsia |
| D046110 | Hypertension, Pregnancy-Induced |
| D002318 | Cardiovascular Diseases |
| D011248 | Pregnancy Complications |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| 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 |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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