Intensive postpartum antihypertensive treatment (IPAT) and healthy lifestyle education: Study protocol for a pilot randomized controlled trial for patients with hypertensive disorders of pregnancy. Contemp Clin Trials 2024 Dec;147:107710
Date
10/13/2024Pubmed ID
39395531Pubmed Central ID
PMC11620922DOI
10.1016/j.cct.2024.107710Scopus ID
2-s2.0-85206254087 (requires institutional sign-in at Scopus site)Abstract
BACKGROUND: Hypertensive disorders of pregnancy (HDP) complicate about 10 % of pregnancies and lead to postpartum hospital readmissions and cardiovascular complications. Following HDP, vascular dysfunction could persist and accelerate the trajectory of cardiovascular disease risk. The benefits of intensive blood pressure (BP) control following HDP have not been adequately investigated. Therefore, no standard guidelines exist to guide the management of mild-to-moderate hypertension in the postpartum period, leading to a wide variation in clinical practice. The present study will investigate the effect of intensive BP control and healthy lifestyle education on maternal cardiovascular health (CVH) and vascular function following HDP.
METHODS: The Intensive Postpartum Antihypertensive Treatment (IPAT) study is a randomized controlled, two-arm, single-site, pilot trial where 60 postpartum HDP patients will be randomized 1:1 to one of two groups: 1) Intensive postpartum BP control - nifedipine initiation at BP ≥140/90 mmHg to maintain BP <140/90 mmHg; or 2) Less intensive postpartum BP control - nifedipine initiation at BP ≥150/100 mmHg to maintain BP <150/100 mmHg. All participants will also undergo vascular function assessments and receive healthy lifestyle education. The study will primarily test feasibility of all study procedures. It will secondarily examine changes in BP and CVH scores from baseline to 12 months postpartum.
CONCLUSION: This pilot trial will study whether the BP threshold of 140/90 is superior to 150/100 for initiation of pharmacotherapy and evaluate feasibility to ultimately conduct a trial capable of generating robust evidence to standardize clinical practice and guidelines in postpartum HDP management.
TRIAL REGISTRATION NUMBER: NCT05687344.
Author List
Palatnik A, Sunji N, Peterson Z, Ohlendorf J, Pan AY, Kulinski JAuthors
Jacquelyn P. Kulinski MD Professor in the Medicine department at Medical College of WisconsinJennifer Ohlendorf PhD, RN Assistant Professor in the College of Nursing department at Marquette University
Anna Palatnik MD Professor in the Obstetrics and Gynecology department at Medical College of Wisconsin
Amy Y. Pan PhD Associate Professor in the Pediatrics department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
AdultAntihypertensive Agents
Blood Pressure
Female
Healthy Lifestyle
Humans
Hypertension, Pregnancy-Induced
Nifedipine
Patient Education as Topic
Pilot Projects
Postpartum Period
Pregnancy
Randomized Controlled Trials as Topic
