Clinical trial NCT03667326: Postpartum Low-Dose Aspirin and Preeclampsia
Official title: Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Preeclampsia Postpartum
Keywords: Aspirin
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Preeclampsia patients will be recruited and randomized to receive either Aspirin or Placebo (n = 90). Additionally, there will be healthy patients (n = 10) recruited to collect the same set of data for comparison with no intervention.
Primary purpose: PREVENTION

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. 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.

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, i.e., 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.

Investigator will also explore a small sub-study to gather information regarding baseline FMD and biomarker values for healthy control postpartum patients, unaffected by preeclampsia and not on LDA during pregnancy or postpartum.

Eligibility 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
* 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).

Primary outcomes:
measure: Change in Flow-Mediated Dilation (FMD)
timeFrame: Up to 3 weeks postpartum
Secondary outcomes:
measure: Change in Systolic blood pressure
timeFrame: Within 3 weeks postpartum
measure: Change in Diastolic blood pressure
timeFrame: Within 3 weeks postpartum
measure: Number of subjects with presentation of disease postpartum (symptoms, severe range BPs, lab abnormalities)
timeFrame: Up to 3 weeks postpartum
measure: Magnesium sulfate re-administration
timeFrame: Up to 3 weeks postpartum
measure: Number of subjects with initiation of, increase in or addition of blood pressure medication
timeFrame: Up to 3 weeks postpartum
measure: Rate of hospital readmissions for postpartum preeclampsia
timeFrame: Up to 3 weeks postpartum
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Aleha Aziz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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
citation: 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.