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Идёт набор NCT05739123

Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

— Наблюдательное Pregnancy Related Pregnancy Complications Pregnancy, High Risk

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: Relugolix-Containing Product.
Кому может быть актуально
Состояния в реестре: Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk. Базовые параметры: от 0 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
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Обзор

The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.

Подробное описание

The outcomes of interest include major congenital malformation (MCM; primary outcome), minor congenital malformation, spontaneous abortion (SAB), stillbirth, elective termination, small for gestational age (SGA), preterm birth, postnatal growth deficiency, and infant developmental deficiency.

Pregnancy outcomes will be assessed throughout pregnancy, with data collection occurring at enrollment, the end of the second trimester, and pregnancy outcome. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery. Enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable, will serve as data reporters to the registry.

The registry is strictly observational; the schedule of office visits and all treatment regimens will be determined by HCPs. Only data that are documented in patients' medical records during the course of medical care will be collected. No additional laboratory tests or HCP assessments will be required as part of this registry.

Вмешательства

  • Препарат Relugolix-Containing Product
    Any relugolix-containing therapy

Первичные конечные точки

  • Major Congenital Malformation (MCM) [Срок оценки: Up to 10 years]
Вторичные конечные точки (8)
  • Minor congenital malformations [Срок оценки: Up to 10 years]
  • Spontaneous abortion (SAB) [Срок оценки: Up to 10 years]
  • Stillbirth [Срок оценки: Up to 10 years]
  • Elective termination [Срок оценки: Up to 10 years]
  • Preterm birth [Срок оценки: Up to 10 years]
  • Small for gestational age (SGA) [Срок оценки: Up to 10 years]
  • Postnatal growth deficiency [Срок оценки: Up to 10 years]
  • Infant developmental deficiency [Срок оценки: Up to 10 years]

Критерии участия

Критерии включения

  • Woman of any age
  • Currently or recently pregnant
  • Consent to participate
  • Authorization for her HCP(s) to provide data to the registry

Cohort 1

  • Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy

Cohort 2

  • Diagnosis of a condition for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix containing therapy at any time during pregnancy

Критерии исключения

The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:

  • Occurrence of pregnancy outcome prior to first contact with the registry coordination center (retrospectively enrolled)
  • Exposure to known teratogens and/or investigational medications during pregnancy
  • Lost to follow-up

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • PPD — Wilmington

Идентификаторы

NCT: NCT05739123 · MVT-601A-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗