Набор скоро начнётся NCT07293728

A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia

Фаза IV С лечением Hypertension 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: Norethindrone 0.35 MG, Drospirenone.
Кому может быть актуально: Состояния в реестре: Hypertension, 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
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is an open-label, randomized feasibility trial in which patients admitted to Oregon Health \& Science University (OHSU) after a pregnancy complicated by preeclampsia who are considering a progestin-only pill contraception postpartum will be randomized to norethindrone or drospirenone for 6 weeks following hospital discharge.

Подробное описание

In this open-label, randomized, feasibility trial, we will recruit participants admitted to OHSU after a pregnancy complicated preeclampsia (diagnosed antepartum or postpartum). All patients admitted after a birth are offered contraception as a routine part of clinical care; only prospective participants who are undecided in their birth control method or who are considering a progestin-only pill contraception will be approached for inclusion.

Participants who consent for enrollment will be randomized to norethindrone or drospirenone. Prescriptions will be filled by the OHSU research pharmacy and delivered to patients prior to discharge. Participants will then receive weekly emails to report medication adherence, home-measured blood pressures (typical standard of care for preeclampsia), and any interval changes in medication or unscheduled healthcare encounters. Follow up will continue through six weeks, consistent with typical close blood pressure monitoring for postpartum patients with preeclampsia. Participants accessing drospirenone through the study who desire to continue after conclusion will be provided with information for obtaining a prescription from their primary provider as well as manufacturer information to reduce prescription costs (as prior authorization requirements are more common with this medication).

Вмешательства

Препарат Norethindrone 0.35 MG
1 tablet (0.35 mg) once daily, taken at the same time each day between hospital discharge following delivery until 6 weeks postpartum.
Препарат Drospirenone
1 tablet (4 mg) once daily for 24 days, followed by 4 inactive tablets. Repeated from hospital discharge following delivery until 6 weeks postpartum.

Первичные конечные точки

Blood Pressure [Срок оценки: Measured weekly for the 6 weeks following delivery.]

Вторичные конечные точки (2)

Antihypertensive Medications [Срок оценки: Collected weekly for the 6 weeks following delivery.]
Follow-Up Visits [Срок оценки: Assessed weekly between delivery and 6 weeks postpartum.]

Критерии участия

Критерии включения

Admission to Oregon Health \& Science University following a birth (during the same admission)
A diagnosis of preeclampsia or chronic hypertension with superimposed preeclampsia (with or without severe features)
Considering use of a progestin-only pill for postpartum contraception