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

Recruiting

• Conditions: Pregnancy Outcomes; Maternal Health

• Registration Number: NCT05154331
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-13
• Study Start: 2022-03-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cohort Term Live Birth Ratio	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.
Cohort Pregnancy Ratio	enrollment - 36 months	Defined as the total number of pregnancies, including live births, stillbirths, and abortions per 1000 women aged 15-49.
Cohort Infant Mortality Ratio	enrollment - 36 months	Defined as the number of deaths in children under one year of age per 1,000 live births.

Trial Locations

Locations (1)

University of Zambia; 🇿🇲 Lusaka, Zambia