Postpartum Low-Dose Aspirin and Preeclampsia
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|ClinicalTrials.gov Identifier: NCT03667326|
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Preeclampsia Postpartum||Drug: Aspirin Drug: Placebo oral capsule||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia|
|Actual Study Start Date :||July 22, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||June 2021|
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.
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 Name: Placebo
- Change in Flow-Mediated Dilation (FMD) [ Time Frame: 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.
- Change in Systolic blood pressure [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667326
|Contact: Natalie Bello, MD, MPHfirstname.lastname@example.org|
|Contact: Aleha Aziz, MD, MPHemail@example.com|
|United States, New York|
|Columbia University Irving Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Aleha Aziz, MD, MPH 646-678-0289 firstname.lastname@example.org|
|Principal Investigator: Natalie Bello, MD, MPH|
|Principal Investigator:||Natalie Bello, MD, MPH||Assistant Professor of Medicine at CUIMC|