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Идёт набор NCT05154331

Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)

Наблюдательное Maternal Health Pregnancy Outcomes

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Maternal Health, Pregnancy Outcomes. Базовые параметры: 1 Day — 49 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Zambia
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The overarching goal of the ARCH Survey is to establish a prospective longitudinal pregnancy surveillance study in Lusaka, Zambia, to precisely characterize the pregnancy rate and outcomes of women of reproductive age prior to, during, and following pregnancy and to investigate the structural, sociodemographic, and clinical covariates that contribute to adverse outcomes in each reproductive epoch.

Подробное описание

The overall purpose of this study is to better understand the health and well-being of women before and after they become pregnant and of their infants. This information will contribute to the understanding of the health needs of women and their children, which may help doctors provide mothers and children with better care in the future.

Participants in this study will be visited four times a year (every 3 months) for up to three years in total. At each visit a review of their medical records, a brief physical exam and urine pregnancy test will be conducted. Participants will also answer survey questions and self-collect vaginal swabs for future testing. We will enroll up to 5,500 women and include any infants that are born to them during their study participation.

Первичные конечные точки

  • Cohort Pregnancy Ratio [Срок оценки: enrollment - 36 months]
  • Cohort Term Live Birth Ratio [Срок оценки: enrollment - 36 months]
  • Cohort Infant Mortality Ratio [Срок оценки: enrollment - 36 months]

Критерии участия

We will initially obtain verbal consent from the head of household (HoH), defined as an available adult (> 18 years old) who is able to provide information about household composition for pre-screening purposes. We will then identify potentially eligible women of reproductive age within each household and invite them to complete study screening procedures.

Women of reproductive age eligibility criteria

Критерии включения

  • Verbal consent obtained from head-of-household
  • 15-49 years of age and a member of household in the catchment area
  • Willing and able to provide written informed consent or assent with next-of-kin consent
  • Willing to undergo study procedures

Критерии исключения

Any other condition (social or medical) that, in the opinion of the study staff, would make participation unsafe or complicate data interpretation. Study staff may note physical, psychological, or social conditions not explicitly stated in the eligibility criteria that could make some women poor candidates for study participation.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Zambia · 1 центр
  • University of Zambia — Lusaka

Идентификаторы

NCT: NCT05154331 · 21-1370

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗