Preeclampsia Postpartum Clinical Trial
— ASAPPOfficial title:
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.
Status | Recruiting |
Enrollment | 86 |
Est. completion date | September 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Miller Children's and Women's Hospital, Long Beach/MemorialCare Long Beach | Long Beach | California |
Lead Sponsor | Collaborator |
---|---|
MemorialCare Health System | University of California, Irvine |
United States,
ACOG Practice Bulletin No. 202: Gestational Hypertension and Preeclampsia. Obstet Gynecol. 2019 Jan;133(1):1. doi: 10.1097/AOG.0000000000003018. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 1 week postpartum | |
Secondary | 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. | 1 week postpartum | |
Secondary | 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. | 6 weeks postpartum | |
Secondary | Anti-hypertensive therapy | This outcome will assess if additional or increased doses of anti-hypertensive therapies are needed following randomization. | 6 weeks postpartum | |
Secondary | Readmission | This outcome will assess if a study participant is readmitted for blood pressure or preeclampsia related reasons following randomization. | 6 weeks postpartum | |
Secondary | 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. | 1 week postpartum | |
Secondary | 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. | 1 week postpartum | |
Secondary | Postpartum hemorrhage | This safety outcome is defined as a postpartum hemorrhage of greater than 1 liter following randomization. | 6 weeks postpartum | |
Secondary | 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. | 6 weeks postpartum | |
Secondary | 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. | 6 weeks postpartum |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05534932 -
Guideline-directed Management and Therapy (GDMT) for the Prevention of Postpartum Cardiac Dysfunction in Preeclamptic African American Women
|
N/A | |
Recruiting |
NCT04632589 -
Losartan for Improved Vascular Endothelial Function After Preeclampsia
|
Early Phase 1 | |
Not yet recruiting |
NCT06373367 -
Preeclampsia Educational Program Study (PrEPS)
|
N/A | |
Recruiting |
NCT05937841 -
Sensitivity of Angiotensin II Type II Receptors in Women Following Preeclampsia
|
Early Phase 1 | |
Recruiting |
NCT03978767 -
Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial
|
Phase 2 | |
Recruiting |
NCT03667326 -
Postpartum Low-Dose Aspirin and Preeclampsia
|
Phase 2 | |
Not yet recruiting |
NCT06353256 -
A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes
|
N/A | |
Recruiting |
NCT04479072 -
Aspirin and Preeclampsia
|
Phase 4 | |
Completed |
NCT03451266 -
Effects of Vitamin C Administration on Extravascular Lung Water in Patients With Severe Features of Preeclampsia
|
Phase 1 |