Aspirin for Postpartum Patients With Preeclampsia (ASAPP)

June 3, 2025 updated by: Megan Oakes, MemorialCare Health System

Acetylsalicylic Acid for Postpartum Preeclampsia: A Pilot Randomized Trial

The purpose of this research study is to evaluate the effect of low-dose aspirin on recovery from severe preeclampsia (a high blood pressure disorder of pregnancy) among women who have given birth. We hypothesize that taking aspirin for the first week after giving birth will enhance recovery from preeclampsia by decreasing the levels of a protein called soluble fms-like tyrosine kinase (sFlt-1), which is thought to be a main contributor to the development of preeclampsia, and speeding up return to a normal blood pressure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Preeclampsia is a condition of the antenatal and postpartum periods, which manifests as new-onset hypertension and end-organ damage. Globally, preeclampsia is estimated to affect up to 9% of all pregnancies, though as many as two-thirds of patients who receive this diagnosis will remain hypertensive beyond the time of their postpartum hospital discharge. Because of this, postpartum preeclampsia is the leading cause of postpartum hospital readmission in the United States. Anti-hypertensive medications and magnesium sulfate are temporizing therapies aimed at preventing the immediate sequelae of preeclampsia such as seizures, stroke, and end-organ damage. However, there are no therapies directly targeting the pathophysiology underlying postpartum preeclampsia, which poses difficulties in promoting blood pressure recovery to a normotensive state.

Preeclampsia is considered a disorder of abnormal placentation, leading to the release of abnormal pro-angiogenic, anti-angiogenic, and vasoactive molecules. Specifically, excess elevations in anti-angiogenic proteins like soluble fms-like tyrosine kinase 1 (sFlt-1) relative to pro-angiogenic proteins like placental growth factor (PlGF) are thought to cause vasospasm and, in turn, hypertension. As such, it seems plausible that persistent postpartum sFlt-1 elevation is implicated in the pathophysiology of postpartum preeclampsia.

At low doses, acetylsalicylic acid, or aspirin, has been proven to target the aforementioned angiogenic imbalance by decreasing serum sFlt-1 levels. While aspirin is widely used during pregnancy to mitigate the risk of preeclampsia, the utility of aspirin in the postpartum period to target these pathways and promote BP recovery to a normotensive state is unknown. The central hypothesis of this trial is that use of aspirin in the first week postpartum will enhance recovery from preeclampsia by improving blood pressure recovery via decreased levels of sFlt-1.

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90740
        • Recruiting
        • Miller Children's and Women's Hospital, Long Beach/MemorialCare Long Beach
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preeclampsia with severe features diagnosed during delivery admission, as defined by ACOG criteria.
  • Pre- and postnatal care provided by the Long Beach Memorial Ob/Gyn resident or Maternal-Fetal Medicine clinic.

Exclusion Criteria:

  • Patient age <18 years old
  • Non-English or Non-Spanish speaking
  • Chronic hypertension diagnosed before 20 weeks' gestation
  • Known allergy, prior adverse reaction, or any medical condition in which aspirin is contraindicated (nasal polyps, gastric or duodenal ulcers, history of gastrointestinal bleeding, severe hepatic dysfunction)
  • Aspirin prescribed postpartum for any other medical condition
  • Bleeding disorder
  • Breastfeeding an infant with thrombocytopenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard blood pressure control plus aspirin 81 mg
Standardized postpartum blood pressure control Aspirin 81 mg by mouth x 1 week post-delivery
Drug: Aspirin 81Mg Ec Tab
Aspirin 81 mg 1 tablet by mouth. Participants randomized to receive aspirin in addition to standard blood pressure management will receive the study medication nightly at 20:00, with first dose initiated within 24 hours of delivery.
No Intervention: Standard blood pressure control
Standardized postpartum blood pressure control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in sFlt-1
Time Frame: 1 week postpartum
This outcome will determine the absolute change in sFlt-1, an anti-angiogenic protein implicated in the pathophysiology of preeclampsia.
1 week postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normotension (ACOG)
Time Frame: 1 week postpartum
This outcome will measure the proportion of patients who achieve a blood pressure of <140/90, as defined by ACOG, without any further elevated values.
1 week postpartum
Normotension (JNC)
Time Frame: 1 week postpartum
This outcome will measure the proportion of patients who achieve a blood pressure of <130/80, as defined by JNC, without any further elevated values.
1 week postpartum
Time to normotension
Time Frame: 6 weeks postpartum
This outcome will assess the length of time in days to normotension after randomization. Normotension will be defined by both ACOG and JNC criteria.
6 weeks postpartum
Anti-hypertensive therapy
Time Frame: 6 weeks postpartum
This outcome will assess if additional or increased doses of anti-hypertensive therapies are needed following randomization.
6 weeks postpartum
Readmission
Time Frame: 6 weeks postpartum
This outcome will assess if a study participant is readmitted for blood pressure or preeclampsia related reasons following randomization.
6 weeks postpartum
Adherence
Time Frame: 1 week postpartum
This outcome will assess for adherence to aspirin therapy in those randomized to the aspirin arm. This is defined as greater than 90% consumption of the prescribed doses.
1 week postpartum
Enrollment feasibility
Time Frame: 1 week postpartum
This outcome will assess feasibility for future studies, defined as both the number of patients randomized by the number of patients eligible and the number of patients who completed the study protocol divided by the number of patients randomized.
1 week postpartum
Postpartum hemorrhage
Time Frame: 6 weeks postpartum
This safety outcome is defined as a postpartum hemorrhage of greater than 1 liter following randomization.
6 weeks postpartum
Postpartum bleeding requiring intervention
Time Frame: 6 weeks postpartum
This safety outcome is defined as postpartum bleeding requiring intervention (uterotonic administration, intrauterine balloon placement, dilation and curettage, or uterine artery embolization) following randomization.
6 weeks postpartum
Unplanned postpartum evaluation for bleeding
Time Frame: 6 weeks postpartum
This safety outcome is defined as the need for urgent evaluation for bleeding in the clinic/office, obstetrical triage unit, or emergency room for vaginal bleeding.
6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MemorialCare Health System

Collaborators

University of California, Irvine

Investigators

  • Principal Investigator: Megan C Oakes, MD MSCI, Miller Children's and Women's Hospital, Long Beach/ MemorialCare Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 371-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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