Aspirin for Postpartum Patients With Preeclampsia

NCT05924971 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 371-23
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

Preeclampsia; Postpartum; Aspirin; sFlt-1

Outcome Measures

Primary Outcomes (1)

• Reduction in sFlt-1

  This outcome will determine the absolute change in sFlt-1, an anti-angiogenic protein implicated in the pathophysiology of preeclampsia.

  1 week postpartum

Secondary Outcomes (10)

• Normotension (ACOG)

  1 week postpartum

• Normotension (JNC)

  1 week postpartum

• Time to normotension

  6 weeks postpartum

• Anti-hypertensive therapy

  6 weeks postpartum

• Readmission

  6 weeks postpartum

Study Arms (2)

Standard blood pressure control plus aspirin 81 mg

EXPERIMENTAL

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

Drug: Aspirin 81Mg Ec Tab

Standard blood pressure control

NO INTERVENTION

Standardized postpartum blood pressure control

Interventions

Aspirin 81Mg Ec Tab DRUG

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.

Standard blood pressure control plus aspirin 81 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MemorialCare Health System: lead
• University of California, Irvine: collaborator

Study Sites (1)

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

Long Beach, California, 90740, United States

RECRUITING

Related Publications (8)

• ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.

  PMID: 30575675 BACKGROUND

• Ditisheim A, Wuerzner G, Ponte B, Vial Y, Irion O, Burnier M, Boulvain M, Pechere-Bertschi A. Prevalence of Hypertensive Phenotypes After Preeclampsia: A Prospective Cohort Study. Hypertension. 2018 Jan;71(1):103-109. doi: 10.1161/HYPERTENSIONAHA.117.09799. Epub 2017 Nov 13.

  PMID: 29133363 BACKGROUND

• Mogos MF, Salemi JL, Spooner KK, McFarlin BL, Salihu HH. Hypertensive disorders of pregnancy and postpartum readmission in the United States: national surveillance of the revolving door. J Hypertens. 2018 Mar;36(3):608-618. doi: 10.1097/HJH.0000000000001594.

  PMID: 29045342 BACKGROUND

• Agrawal S, Cerdeira AS, Redman C, Vatish M. Meta-Analysis and Systematic Review to Assess the Role of Soluble FMS-Like Tyrosine Kinase-1 and Placenta Growth Factor Ratio in Prediction of Preeclampsia: The SaPPPhirE Study. Hypertension. 2018 Feb;71(2):306-316. doi: 10.1161/HYPERTENSIONAHA.117.10182. Epub 2017 Dec 11.

  PMID: 29229743 BACKGROUND

• Su MT, Wang CY, Tsai PY, Chen TY, Tsai HL, Kuo PL. Aspirin enhances trophoblast invasion and represses soluble fms-like tyrosine kinase 1 production: a putative mechanism for preventing preeclampsia. J Hypertens. 2019 Dec;37(12):2461-2469. doi: 10.1097/HJH.0000000000002185.

  PMID: 31335509 BACKGROUND

• Lin L, Li G, Zhang W, Wang YL, Yang H. Low-dose aspirin reduces hypoxia-induced sFlt1 release via the JNK/AP-1 pathway in human trophoblast and endothelial cells. J Cell Physiol. 2019 Aug;234(10):18928-18941. doi: 10.1002/jcp.28533. Epub 2019 Apr 19.

  PMID: 31004367 BACKGROUND

• Neuman RI, Figaroa AMJ, Nieboer D, Saleh L, Verdonk K, Danser AHJ, Duvekot HJJ, van den Meiracker AH, Roeters van Lennep J, Visser W. Angiogenic markers during preeclampsia: Are they associated with hypertension 1 year postpartum? Pregnancy Hypertens. 2021 Mar;23:116-122. doi: 10.1016/j.preghy.2020.11.011. Epub 2020 Dec 3.

  PMID: 33321329 BACKGROUND

• Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.

  PMID: 29133354 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Megan C Oakes, MD MSCI

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan C Oakes, MD MSCI

CONTACT

562-997-8510; moakes2@memorialcare.org

Ashten B Waks, MD MSPH

CONTACT

562-997-8510; awaks@memorialcare.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to study arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSCI

Model Details: Patients with preeclampsia will be randomized after delivery to receive either standard blood pressure control plus aspirin 81 mg or standard blood pressure control alone.

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: July 26, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)