Postpartum Low-Dose Aspirin and Preeclampsia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Preeclampsia is a serious disease of pregnancy that manifests with increased blood pressure and can affect all the organs in a woman's body. It usually develops after 20 weeks of pregnancy. There is an abnormal amount of protein in the urine and with worsening disease known as "severe features," patients can have pain in the upper abdomen, changes in vision, fluid in the lungs, an intense headache, low number of platelets in the blood, and abnormal liver or kidney function. Very high blood pressure is also considered a severe feature. The exact cause of preeclampsia is unknown but women with the condition are at increased risk for complications during pregnancy, including seizures - eclampsia. Babies are at risk of being born premature because the only cure for preeclampsia is delivery. Women who have had preeclampsia are also at increased risk of cardiovascular and kidney disease later in life, including heart attack, stroke and high blood pressure.Studies show that women at high risk for preeclampsia, ie. have had preeclampsia in a prior pregnancy, are carrying more than one fetus, have a history of high blood pressure, kidney disease or both, have certain medical problems such as diabetes, thrombophilia or lupus, have a modestly decreased risk of disease with daily intake of low-dose aspirin starting after 12 weeks of pregnancy.
Due to the limited data available on the topic of LDA in preeclamptic patients in the postpartum period, particularly as applicable to the American population, the investigator intends to start with a small pilot study involving the collection of information on 10 women not exposed to study intervention. This will allow for confirmation of the sample size based on the baseline FMD measurements 2 days after delivery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Low-Dose Aspirin (LDA) Intervention Group Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take 81mg of aspirin daily for up to 3 weeks postpartum, starting within 4 days after delivery. |
Drug: Aspirin
Low dose aspirin, 81mg tablets, PO
|
| Placebo Comparator: Placebo Control Group Subjects diagnosed with severe preeclampsia prior to delivery (antepartum or intrapartum) will take placebo oral capsule daily for up to 3 weeks postpartum, starting within 4 days after delivery. |
Drug: Placebo oral capsule
Placebo oral capsule, PO
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Flow-Mediated Dilation (FMD) [Up to 3 weeks postpartum]
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.
Secondary Outcome Measures
- Change in Systolic blood pressure [Within 3 weeks postpartum]
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.
- Change in Diastolic blood pressure [Within 3 weeks postpartum]
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.
- Number of subjects with presentation of disease postpartum (symptoms, severe range BPs, lab abnormalities) [Up to 3 weeks postpartum]
This is to measure if patients will experience decreased severity of disease when taking daily LDA in the postpartum period.
- Magnesium sulfate re-administration [Up to 3 weeks postpartum]
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?
- Number of subjects with initiation of, increase in or addition of blood pressure medication [Up to 3 weeks postpartum]
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.
- Rate of hospital readmissions for postpartum preeclampsia [Up to 3 weeks postpartum]
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.
Eligibility Criteria
Criteria
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
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Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) - exception if taking LDA in pregnancy
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Nasal polyps
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Gastric or Duodenal ulcers, history of GI bleeding
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Severe hepatic dysfunction
-
Bleeding disorders and diathesis
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Breastfeeding a newborn with low platelets (NAIT)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Irving Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
Investigators
- Principal Investigator: Natalie Bello, MD, MPH, Assistant Professor of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review. English, Portuguese.
- 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
- AAAR9439