Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,500
- 试验地点
- 2
- 主要终点
- Cohort Term Live Birth Ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •Inclusion criteria:
- •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
排除标准
- •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.
研究组 & 干预措施
Women of reproductive age
Women 15-49 years of age
结局指标
主要结局
Cohort Term Live Birth Ratio
时间窗: enrollment - 36 months
Defined as the proportion of pregnancies that result in a live birth at or beyond 37 gestational weeks per 1,000 pregnancies.
Cohort Pregnancy Ratio
时间窗: enrollment - 36 months
Defined as the total number of pregnancies, including live births, stillbirths, and abortions per 1000 women aged 15-49.
Cohort Infant Mortality Ratio
时间窗: enrollment - 36 months
Defined as the number of deaths in children under one year of age per 1,000 live births.
次要结局
未报告次要终点