Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Maternal Health, Pregnancy Outcomes. Basic parameters: 1 Day — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Zambia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Cohort Pregnancy Ratio [Time frame: enrollment - 36 months]
- Cohort Term Live Birth Ratio [Time frame: enrollment - 36 months]
- Cohort Infant Mortality Ratio [Time frame: enrollment - 36 months]
Eligibility criteria
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
Exclusion criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Zambia · 1 center
- University of Zambia — Lusaka
Identifiers
NCT: NCT05154331 · 21-1370