University of Zambia
Lusaka, Zambia
NCT Number: NCT05154331
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.
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Notify Me1 day–49 year
All sexes
Observational
Lusaka, Zambia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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.
Time frame: enrollment - 36 months
Defined as the total number of pregnancies, including live births, stillbirths, and abortions per 1000 women aged 15-49.
Time frame: 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.
Time frame: enrollment - 36 months
Defined as the number of deaths in children under one year of age per 1,000 live births.
University of North Carolina, Chapel Hill
Other
Acronym: ARCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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