Recruiting
Phase 2

Aspirin

Sponsor:

MemorialCare Health System

Code:

NCT05924971

Conditions

Preeclampsia Postpartum

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aspirin 81Mg Ec Tab

Study Details

Brief summary:

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.

Conditions

Preeclampsia Postpartum

Study ID

NCT05924971

Start date

Jul 26, 2023

Status verified date

May, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

86 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Standard blood pressure control plus aspirin 81 mg

Standardized postpartum blood pressure control Aspirin 81 mg by mouth x 1 week post-delivery

no intervention: Standard blood pressure control

Standardized postpartum blood pressure control

Interventions

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.

Primary outcome measure

  • Reduction in sFlt-1 [ Time Frame: 1 week postpartum ]

Central Contacts and Locations

Central contacts

Megan C Oakes, MD MSCI

562-997-8510moakes2@memorialcare.org

Ashten B Waks, MD MSPH

562-997-8510awaks@memorialcare.org

Locations

Miller Children's and Women's Hospital, Long Beach/MemorialCare Long Beach

Recruiting

Long Beach, California, United States, 90740

Contacts

Megan Oakes, MD

562-997-8510moakes2@memorialcare.org

More Information

Sponsor

MemorialCare Health System

Last update posted

Jun 6, 2025

Last verified

May, 2025

Keywords

  • Preeclampsia
  • Postpartum
  • Aspirin
  • sFlt-1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by MemorialCare Health System on 2025-06-06.