Preeclampsia Postpartum Clinical Trial
Official title:
Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
The purpose of this research study is to find out whether women with severe preeclampsia taking low-dose aspirin (LDA) for 3 weeks post-delivery will experience an improvement in endothelial function (measured as flow-mediated dilation - FMD) and severity of disease, as the effects of preeclampsia can persist postpartum. Women diagnosed with severe preeclampsia prior to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or placebo to take daily for up to 3 weeks post-delivery. Exploratory objective includes healthy control postpartum patients without preeclampsia and not on LDA during pregnancy or postpartum in comparison with the primary study population affected by preeclampsia with severe features.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Singleton or Multiple gestation - Maternal age >= 18 years - 20 0/7 weeks gestation or greater - Severe Preeclampsia diagnosed prior to delivery Exclusion Criteria: - Aspirin use postpartum for other medical indication - Lovenox, unfractionated heparin, or other anticoagulant use postpartum for an indication other than postoperative (in-house) - Aspirin use within 7 days of planned initial FMD testing postpartum - Hypersensitivity or allergy to Aspirin or other salicylates - Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) - exception if taking LDA in pregnancy - Nasal polyps - Gastric or Duodenal ulcers, history of GI bleeding - Severe hepatic dysfunction - Bleeding disorders and diathesis - Breastfeeding a newborn with low platelets (NAIT) For sub-study patients, inclusion and exclusion criteria will be the same, with the exception of diagnosis of severe preeclampsia prior to delivery (exclusion criterion for healthy controls group). |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Costa AC, Reina-Couto M, Albino-Teixeira A, Sousa T. Aspirin and blood pressure: Effects when used alone or in combination with antihypertensive drugs. Rev Port Cardiol. 2017 Jul-Aug;36(7-8):551-567. doi: 10.1016/j.repc.2017.05.008. Epub 2017 Jul 3. English, Portuguese. — View Citation
The American College of Obstetricians and Gynecologists. Practice Advisory on Low-Dose Aspirin and Prevention of Preeclampsia: Updated Recommendations [Internet]. 2016. Available from: https://www.acog.org/Clinical-Guidance-and-Publications/Practice-Advisories/Practice-Advisory-Low-Dose-Aspirin-and-Prevention-of-Preeclampsia-Updated-Recommendations
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Flow-Mediated Dilation (FMD) | This is designed to measure if patients with preeclampsia with severe features diagnosed antepartum or intrapartum, will experience an increase in Flow-Mediated Dilation (FMD) - a measure of endothelial function - within 3 weeks after delivery when taking daily LDA in the postpartum period. | Up to 3 weeks postpartum | |
Secondary | Change in Systolic blood pressure | This is to measure if patients will experience a decrease in systolic blood pressure (SBP) within 3 weeks after delivery when taking daily LDA in the postpartum period. | Within 3 weeks postpartum | |
Secondary | Change in Diastolic blood pressure | This is to measure if patients will experience a decrease in diastolic blood pressure (DBP) within 3 weeks after delivery when taking daily LDA in the postpartum period. | Within 3 weeks postpartum | |
Secondary | Number of subjects with presentation of disease postpartum (symptoms, severe range BPs, lab abnormalities) | This is to measure if patients will experience decreased severity of disease when taking daily LDA in the postpartum period. | Up to 3 weeks postpartum | |
Secondary | Magnesium sulfate re-administration | This is to measure if patients will experience a decreased likelihood of receiving magnesium sulfate postpartum again when taking daily LDA in the postpartum period? | Up to 3 weeks postpartum | |
Secondary | Number of subjects with initiation of, increase in or addition of blood pressure medication | This is to measure if patients will experience a decreased rate in initiation of/ increase in/ addition of blood pressure medication postpartum when taking daily LDA in the postpartum period. | Up to 3 weeks postpartum | |
Secondary | Rate of hospital readmissions for postpartum preeclampsia | This is to measure if patients will experience a decreased rate of hospital readmissions for postpartum preeclampsia when taking daily LDA in the postpartum period. | Up to 3 weeks postpartum |
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