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

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.

Study Overview

• Status: Recruiting
• Conditions: Maternal Health; Pregnancy Outcomes

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 Type: Observational
• Enrollment (Estimated): 7500

Contacts and Locations

• Study Contact: Name: Mutale Sampa; Phone Number: +260977287091; Email: mutalesampa65@gmail.com

Study Locations

• Zambia
  • Lusaka, Zambia
    • Recruiting
    • University of Zambia
    • Contact: Mutale Sampa; Phone Number: +260977287091; Email: mutalesampa65@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Women of reproductive age and their infants born during their study participation

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Women of reproductive age; Women 15-49 years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort Pregnancy Ratio	Defined as the total number of pregnancies, including live births, stillbirths, and abortions per 1000 women aged 15-49.	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.	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.	enrollment - 36 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Bill and Melinda Gates Foundation; University of Zambia
• Investigators: Principal Investigator: Jeff Stringer, University of North Carolina, Chapel Hill; Principal Investigator: Wilbroad Mutale, MD, University of Zambia (UNZA) Lusaka, Zambia

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pregnancy health
• Other Study ID Numbers: 21-1370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9-36 months following publication
• IPD Sharing Access Criteria: noted above

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No