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Aspirin for Postpartum Patients With Preeclampsia (ASAPP)

Primary Purpose

Preeclampsia Postpartum

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Aspirin 81Mg Ec Tab
Sponsored by
MemorialCare Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia Postpartum focused on measuring Preeclampsia, Postpartum, Aspirin, sFlt-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Standard blood pressure control plus aspirin 81 mg

    Standard blood pressure control

    Arm Description

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

    Standardized postpartum blood pressure control

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Normotension (ACOG)
    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.
    Normotension (JNC)
    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.
    Time to normotension
    This outcome will assess the length of time in days to normotension after randomization. Normotension will be defined by both ACOG and JNC criteria.
    Anti-hypertensive therapy
    This outcome will assess if additional or increased doses of anti-hypertensive therapies are needed following randomization.
    Readmission
    This outcome will assess if a study participant is readmitted for blood pressure or preeclampsia related reasons following randomization.
    Adherence
    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.
    Enrollment feasibility
    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.
    Postpartum hemorrhage
    This safety outcome is defined as a postpartum hemorrhage of greater than 1 liter following randomization.
    Postpartum bleeding requiring intervention
    This safety outcome is defined as postpartum bleeding requiring intervention (uterotonic administration, intrauterine balloon placement, dilation and curettage, or uterine artery embolization) following randomization.
    Unplanned postpartum evaluation for bleeding
    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.

    Full Information

    First Posted
    June 21, 2023
    Last Updated
    June 21, 2023
    Sponsor
    MemorialCare Health System
    Collaborators
    University of California, Irvine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05924971
    Brief Title
    Aspirin for Postpartum Patients With Preeclampsia
    Acronym
    ASAPP
    Official Title
    Acetylsalicylic Acid for Postpartum Preeclampsia: A Pilot Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    September 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    MemorialCare Health System
    Collaborators
    University of California, Irvine

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preeclampsia Postpartum
    Keywords
    Preeclampsia, Postpartum, Aspirin, sFlt-1

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    Outcomes Assessor
    Masking Description
    The outcomes assessor will be blinded to study arms.
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard blood pressure control plus aspirin 81 mg
    Arm Type
    Experimental
    Arm Description
    Standardized postpartum blood pressure control Aspirin 81 mg by mouth x 1 week post-delivery
    Arm Title
    Standard blood pressure control
    Arm Type
    No Intervention
    Arm Description
    Standardized postpartum blood pressure control
    Intervention Type
    Drug
    Intervention Name(s)
    Aspirin 81Mg Ec Tab
    Intervention Description
    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 Information:
    Title
    Reduction in sFlt-1
    Description
    This outcome will determine the absolute change in sFlt-1, an anti-angiogenic protein implicated in the pathophysiology of preeclampsia.
    Time Frame
    1 week postpartum
    Secondary Outcome Measure Information:
    Title
    Normotension (ACOG)
    Description
    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.
    Time Frame
    1 week postpartum
    Title
    Normotension (JNC)
    Description
    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.
    Time Frame
    1 week postpartum
    Title
    Time to normotension
    Description
    This outcome will assess the length of time in days to normotension after randomization. Normotension will be defined by both ACOG and JNC criteria.
    Time Frame
    6 weeks postpartum
    Title
    Anti-hypertensive therapy
    Description
    This outcome will assess if additional or increased doses of anti-hypertensive therapies are needed following randomization.
    Time Frame
    6 weeks postpartum
    Title
    Readmission
    Description
    This outcome will assess if a study participant is readmitted for blood pressure or preeclampsia related reasons following randomization.
    Time Frame
    6 weeks postpartum
    Title
    Adherence
    Description
    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.
    Time Frame
    1 week postpartum
    Title
    Enrollment feasibility
    Description
    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.
    Time Frame
    1 week postpartum
    Title
    Postpartum hemorrhage
    Description
    This safety outcome is defined as a postpartum hemorrhage of greater than 1 liter following randomization.
    Time Frame
    6 weeks postpartum
    Title
    Postpartum bleeding requiring intervention
    Description
    This safety outcome is defined as postpartum bleeding requiring intervention (uterotonic administration, intrauterine balloon placement, dilation and curettage, or uterine artery embolization) following randomization.
    Time Frame
    6 weeks postpartum
    Title
    Unplanned postpartum evaluation for bleeding
    Description
    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.
    Time Frame
    6 weeks postpartum

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Megan C Oakes, MD MSCI
    Phone
    562-997-8510
    Email
    moakes2@memorialcare.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashten B Waks, MD MSPH
    Phone
    562-997-8510
    Email
    awaks@memorialcare.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Megan C Oakes, MD MSCI
    Organizational Affiliation
    Miller Children's and Women's Hospital, Long Beach/ MemorialCare Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30575675
    Citation
    ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018.
    Results Reference
    background
    PubMed Identifier
    29133363
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29045342
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29229743
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31335509
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31004367
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33321329
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29133354
    Citation
    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. Erratum In: Hypertension. 2018 Jun;71(6):e136-e139. Hypertension. 2018 Sep;72(3):e33.
    Results Reference
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