1. Intensive postpartum antihypertensive treatment (IPAT) and healthy lifestyle education: Study protocol for a pilot randomized controlled trial for patients with hypertensive disorders of pregnancy.
- Author
-
Palatnik A, Sunji N, Peterson Z, Ohlendorf J, Pan AY, and Kulinski J
- Subjects
- Humans, Female, Pregnancy, Pilot Projects, Adult, Healthy Lifestyle, Patient Education as Topic methods, Patient Education as Topic organization & administration, Blood Pressure drug effects, Antihypertensive Agents therapeutic use, Antihypertensive Agents administration & dosage, Nifedipine therapeutic use, Nifedipine administration & dosage, Postpartum Period, Hypertension, Pregnancy-Induced drug therapy
- 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., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)
- Published
- 2024
- Full Text
- View/download PDF