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Recruiting NCT05154331

NCT05154331 Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)

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Clinical Trial Summary
NCT ID NCT05154331
Status Recruiting
Phase
Sponsor University of North Carolina, Chapel Hill
Condition Maternal Health
Study Type OBSERVATIONAL
Enrollment 7,500 participants
Start Date 2022-03-29
Primary Completion 2026-06-01

Trial Parameters

Condition Maternal Health
Sponsor University of North Carolina, Chapel Hill
Study Type OBSERVATIONAL
Phase N/A
Enrollment 7,500
Sex ALL
Min Age 1 Day
Max Age 49 Years
Start Date 2022-03-29
Completion 2026-06-01

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Brief Summary

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.

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

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