- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03299491
An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
A three-arm cluster trial design will be used to measure the impact of the intervention packages in three districts (Gomma, Seka Chekorsa, Kersa) in Jimma Zone, Ethiopia. Twenty-four clusters with 160 individuals each are required to detect a 17% change in the primary outcome (proportion of facility-based births) with 80% power,assuming a cluster autocorrelation of 0.8 and an intra-cluster correlation coefficient of 0.1. Primary health care units (PHCU) which consist of a health centre and several community-based health posts will serve as trial clusters. All PHCUs with maternity waiting areas (MWAs) constructed will be eligible for selection. Eligible women will be randomly selected from PHCU catchment areas stratified by MWA functionality and health centre basic emergency obstetric care (BEmOC) capacity. This is to ensure balanced distribution of poorly functioning MWAs and facilities with diminished BEmOC capacity between trial arms.
Cross-sectional household surveys will be conducted with eligible women to collect information on socio-demographics, knowledge, attitudes and practices regarding maternal health services, reproductive history and maternal health service utilization. Surveys will be administered by trained interviewers on tablet computers programmed using Open Data Kit at baseline prior to intervention roll out and at endline. Multilevel regression models will be used to quantify the effect of the intervention packages on outcomes of interest. Random effect terms for PHCUs will be included to account for the clustered nature of the data.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Women who were pregnant up to one year prior to the baseline survey and had a live birth, stillbirth or abortion (spontaneous or induced) and are residents in the study districts during the survey period are eligible to take part in the study.
Exclusion Criteria:
- Women who are not able to provide informed consent due to severe illness or mental health conditions.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Контроль
|
|
|
Экспериментальный: MWA+IEC intervention
|
The MWA intervention will involve upgrading existing maternity waiting areas to ensure that essential supplies and services are available to create a comfortable environment for women to temporarily reside in and have easy access to skilled obstetric services.
Community and religious leaders will each attend one-day workshops designed using participatory, adult learning methods to help participants better understand the importance of maternal health care services, identify barriers to accessing care and to strategize how to promote utilization of services. Half-day workshops will conducted in subsequent years to build on shared experiences. Health extension workers will attend 3-day workshops to identify enablers and barriers to implementation of the safe motherhood components of the health extension program and strategize on how to engage community and religious leaders to support access to maternal health care services in their communities. Half-day workshops will conducted in subsequent years for each of the participant groups to build on shared experiences. |
|
Экспериментальный: IEC intervention
|
Community and religious leaders will each attend one-day workshops designed using participatory, adult learning methods to help participants better understand the importance of maternal health care services, identify barriers to accessing care and to strategize how to promote utilization of services. Half-day workshops will conducted in subsequent years to build on shared experiences. Health extension workers will attend 3-day workshops to identify enablers and barriers to implementation of the safe motherhood components of the health extension program and strategize on how to engage community and religious leaders to support access to maternal health care services in their communities. Half-day workshops will conducted in subsequent years for each of the participant groups to build on shared experiences. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Facility-based birth coverage
Временное ограничение: Information on the primary outcome will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
|
Proportion of women who report giving birth to their last child at a health facility (health centre or hospital) which has skilled birth attendants present (doctor, midwife, clinical nurse).
|
Information on the primary outcome will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Antenatal care coverage
Временное ограничение: Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
|
Proportion of women who report making at least one antenatal care visit to a health facility during their last pregnancy.
|
Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
|
|
Postnatal care coverage
Временное ограничение: Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
|
Proportion of women who report receiving a checkup from a healthcare worker at least once during the 42 days after delivery of their last child.
|
Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Manisha Kulkarni, PhD, University of Ottawa
- Главный следователь: Lakew Abebe, MPH, Jimma University
Публикации и полезные ссылки
Общие публикации
- Kurji J, Gebretsadik LA, Wordofa MA, Morankar S, Bedru KH, Bulcha G, Bergen N, Kiros G, Asefa Y, Asfaw S, Mamo A, Endale E, Thavorn K, Labonte R, Taljaard M, Kulkarni MA. Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia. BMC Public Health. 2020 Oct 22;20(1):1593. doi: 10.1186/s12889-020-09692-4.
- Kurji J, Kulkarni MA, Gebretsadik LA, Wordofa MA, Morankar S, Bedru KH, Bulcha G, Thavorn K, Labonte R, Taljaard M. Effectiveness of upgraded maternity waiting homes and local leader training in improving institutional births among women in the Jimma zone, Ethiopia: study protocol for a cluster-randomized controlled trial. Trials. 2019 Dec 4;20(1):671. doi: 10.1186/s13063-019-3755-z.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 108028-002
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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