Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT07185204
Brief Summary:
The goal of this study is to address the significant morbidity associated with preeclampsia diagnosed after delivery. All participants will undergo biomarker evaluation with soluble fms-like tyrosine kinase-1 and placental growth factor (sFlt-1/PlGF) ratio testing before delivery to assess the predictive ability of these biomarkers with new-onset postpartum preeclampsia. High-risk participants will be randomized to a bundle of care strategies aimed at early detection and management of postpartum preeclampsia.
Detailed Description:
This is a pilot randomized controlled trial of 60 normotensive, pregnant patients randomized to early monitoring and management for postpartum preeclampsia after biomarker evaluation with sFlt-1/PlGF ratio. After obtaining informed consent, participants will undergo preeclampsia risk assessment using sFlt-1/PlGF ratio testing prior to delivery. Patients with a low risk ratio will receive routine postpartum care. Patients with a high risk ratio will be randomized 1:1 to the intervention bundle focused on early detection and management of postpartum preeclampsia versus routine postpartum care. The intervention bundle will include remote blood pressure monitoring, education, and dispensing antihypertensive medication (nifedipine ER) for outpatient management of asymptomatic, mild-range BP. The primary outcome is the feasibility of all study procedures, measured by recruitment, retention, adherence, and acceptability. The secondary outcome is to assess the effect of early monitoring and management of postpartum preeclampsia on the composite outcome of hypertension requiring in-person medical evaluation and hypertension-related morbidity. Finally, the exploratory outcome is the predictive ability of sFlt-1/PlGF ratio of de novo postpartum preeclampsia in antenatally normotensive patients who are at risk for HDP based on ACOG/USPSTF criteria. Data on primary and secondary outcomes will be collected from both randomized groups and the non-randomized group with low-risk sFlt-1/PlGF ratio to determine the predictive capability of the test in the postpartum period.
Study:
NCT07185204
Study Brief:
Protocol Section:
NCT07185204