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Идёт набор NCT06723392

Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries

Фаза III С лечением Preterm Birth Small for Gestational Age (SGA) Stillbirth Bacteriuria (Asymptomatic) in Pregnancy

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: Oral nitrofurantoin monohydrate/macrocrystals, Placebo.
Кому может быть актуально
Состояния в реестре: Preterm Birth, Small for Gestational Age (SGA), Stillbirth, Bacteriuria (Asymptomatic) in Pregnancy. Базовые параметры: 18 лет — 49 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
Bangladesh, Democratic Republic of the Congo, Guatemala, Индия, Пакистан +1
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

Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries: A Randomized Controlled Trial of the Global Network for Women's and Children's Health Research

Обзор

This study, Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (ABLE), is designed as a 2-arm randomized controlled trial (RCT) focused on pregnant individuals and newborn infants. A positive outcome of this study will contribute to global progress toward WHO Sustainable Development Goal Target 3.2 \[End preventable deaths of newborns and children under 5 years of age\] by examining the potential impact of this practice to reduce the incidence of SVN/SB and the lifelong health consequences associated with SVNs. In addition, the study will further explore the role and potential benefits of antibiotic treatment of AB in the pregnant individual. In total, 1,134 eligible participants, or approximately 162 per research site, will be randomized in the trial by the research teams in each of the seven international sites that, together with their United States of America (US) partners, participate in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's (NICHD's) Global Network for Women's and Children's Health Research (GN).

Вмешательства

  • Препарат Oral nitrofurantoin monohydrate/macrocrystals
    7-day course of oral nitrofurantoin monohydrate/macrocrystals 100 mg twice daily (total of 14 doses)
  • Другое Placebo
    7-day course of oral placebo 100 mg twice daily (total of 14 doses)

Первичные конечные точки

  • Number of small vulnerable newborn (SVN) or stillbirth (SB) [Срок оценки: From Pregnancy until 42 days postpartum]

Критерии участия

Критерии включения

Individuals who meet the following criteria are eligible for randomization:

  • Enrolled in GN MNHR
  • Established pregnancy ≥12 and ≤20 weeks GA by last menstrual period and/or clinical assessment and/or ultrasonography
  • Age: 18 years (or lower limit age eligible\*) to 49 years

\* Some sites will be able to include individuals giving birth regardless of age if they are considered an adult or an emancipated minor. However, other sites will require individuals to be at least 18 years of age. The investigators will adhere to local regulations.

  • Expressed understanding of study procedures and willingness to complete screening, randomization, study drug administration and follow-up
  • Able to provide informed consent
  • Presence of a single bacterial isolate (>105 colony forming unit (CFU)/mL) in urine at enrollment
  • Intent to remain in study area for at least 42 days PP

Критерии исключения

Individuals who meet any of the following criteria are not eligible for randomization:

  • Gestational age <12 weeks or >20 weeks
  • Received treatment with any antibiotic within 14 days before screening visit
  • Current symptoms of UTI
  • History of allergy to nitrofurantoin
  • Pregnancy loss / miscarriage prior to randomization
  • Currently taking magnesium-containing antacid
  • Any illness / condition (e.g., anemia, diabetes, renal disease, pulmonary disease) requiring immediate medical care per site PI assessment
  • Enrollment in another trial that per the study MOP will impact this trial

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Индия · 2 центра
  • KLE Academy of Higher Education and Research — Belagavi
  • Lata Medical Research Foundation — Nagpur
Bangladesh · 1 центр
  • Icddr,B — Dhaka
Democratic Republic of the Congo · 1 центр
  • Kinshasa School of Public Health — Kinshasa
Guatemala · 1 центр
  • Institue for Nutrition of Central America and Panama (INCAP) — Guatemala City
Пакистан · 1 центр
  • Aga Khan University — Karachi
Zambia · 1 центр
  • University Teaching Hospital — Lusaka

Идентификаторы

NCT: NCT06723392 · CP ABLE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗