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

University of North Carolina, Chapel Hill7,500 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

7,500

Conditions

Maternal Health Pregnancy Outcomes

Eligibility

Sex: ALLMin age: 1 DayMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Zambia

Lusaka, Zambia

RECRUITING

Outcomes

Primary Outcomes

Cohort Pregnancy Ratio

Defined as the total number of pregnancies, including live births, stillbirths, and abortions per 1000 women aged 15-49.

Time frame: enrollment - 36 months

Cohort Term Live Birth Ratio

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

Cohort Infant Mortality Ratio

Defined as the number of deaths in children under one year of age per 1,000 live births.

Time frame: enrollment - 36 months

Central Contacts

Mutale Sampa

CONTACT

+260977287091 mutalesampa65@gmail.com

Data from ClinicalTrials.gov

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