Postpartum Low-Dose Aspirin and Preeclampsia

NCT ID: NCT03667326

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-22
• Study Completion Date: 2026-12-31

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.

Conditions

Preeclampsia Postpartum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aspirin tablet

Intervention Type: DRUG

Low dose aspirin, 81mg tablets, PO

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.

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Placebo oral capsule, PO

Healthy Controls Group

Subjects who are healthy volunteers (n = 10) without severe preeclampsia prior to delivery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Aspirin tablet

Low dose aspirin, 81mg tablets, PO

Intervention Type: DRUG

Placebo oral capsule

Placebo oral capsule, PO

Intervention Type: DRUG

Other Intervention Names

Aspirin; Placebo

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Aleha Aziz

Assistant Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aleha Aziz, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aleha Aziz, MD, MPH

Role: CONTACT

aa4065@cumc.columbia.edu

646-678-0289

Facility Contacts

Aleha Aziz, MD, MPH

Role: primary

aa4065@cumc.columbia.edu

646-678-0289

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 28684123 (View on PubMed)

Other Identifiers

AAAR9439

Identifier Type: -

Identifier Source: org_study_id