Clinical trial NCT05154331: Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)
Official title: Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Maternal Health
Pregnancy Outcomes
Keywords: pregnancy health
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: University of Zambia
First posted: 2021-12-13
Enrollment: 7500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women of reproductive age and their infants born during their study participation

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.

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.

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.

Primary outcomes:
measure: Cohort Pregnancy Ratio
timeFrame: enrollment - 36 months
measure: Cohort Term Live Birth Ratio
timeFrame: enrollment - 36 months
measure: Cohort Infant Mortality Ratio
timeFrame: enrollment - 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University of Zambia
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jeff Stringer
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Zambia (UNZA) Lusaka, Zambia
name: Wilbroad Mutale, MD
role: PRINCIPAL_INVESTIGATOR
References: