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

NCT05154331 | Recruiting

• 1 other identifier: 21-1370
• Study Type: observational
• Target: 7,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Health; Pregnancy Outcomes

Keywords

pregnancy health

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Women of reproductive age

Women 15-49 years of age

Eligibility Criteria

• Age: 1 Day - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Verbal consent obtained from head-of-household
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Bill and Melinda Gates Foundation: collaborator
• University of Zambia: collaborator

Study Sites (1)

University of Zambia

Lusaka, Zambia

RECRUITING

Study Officials

• Jeff Stringer

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Wilbroad Mutale, MD

  University of Zambia (UNZA) Lusaka, Zambia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mutale Sampa

CONTACT

+260977287091; mutalesampa65@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 13, 2021
• Study Start: March 29, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9-36 months following publication
• Access Criteria: noted above

Locations

ZA (1)