Идёт набор NCT07185204

Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study

Без фазы С лечением Postpartum Preeclampsia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Early detection and management of postpartum preeclampsia bundle.
Кому может быть актуально: Состояния в реестре: Postpartum Preeclampsia. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Nepal
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Postpartum Preeclampsia Early Detection and Treatment: Using Biomarkers to Implement Risk-stratified Intervention (Nepal Pilot Randomized Controlled Trial)

Обзор

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.

Подробное описание

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.

Вмешательства

Другое Early detection and management of postpartum preeclampsia bundle
Remote blood pressure monitoring, education, and dispensing antihypertensive medication (nifedipine ER) for outpatient management of asymptomatic, mild range BP.

Первичные конечные точки

Study feasibility [Срок оценки: 1 year]

Вторичные конечные точки (2)

Composite outcome of hypertension-related healthcare utilization and morbidity. [Срок оценки: 4 weeks postpartum]
Predictive ability of sFlt-1/PlGF ratio for de novo postpartum preeclampsia [Срок оценки: 2 weeks postpartum]

Критерии участия

Критерии включения

Pregnant patients ≥ 36 weeks gestation without major fetal anomalies
Age ≥ 18 years
Admitted for labor at Dhulikhel Hospital, or intend to deliver at Dhulikhel Hospital
At risk for preeclampsia, using the Clinical Risk Assessment for Preeclampsia according to ACOG and USPSTF

1 or more high risk factors:

History of preeclampsia
Type 1 or 2 diabetes
Multifetal gestation?
Renal disease
Autoimmune disease
2 or more moderate risk factors:

Nulliparity
BMI > 30
First-degree relative with a history of preeclampsia
African American race
Low socioeconomic status
Age > 35 years
History of low birthweight or small for gestational age
Previous adverse pregnancy outcome
Interpregnancy interval > 10 years

Критерии исключения

Antenatal hypertensive disorder of pregnancy diagnosis, including gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines
Chronic hypertension, according to ACOG guidelines
Known allergy or contraindication to nifedipine
Inability or unwillingness to provide informed consent
Two or more blood pressures with an SBP ≥140 or DBP ≥90 after consent and prior to sFlt-1/PlGF testing (screen failure criteria)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет