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Recruiting

NCT Number: NCT05154331

Antenatal and Postnatal Care Research Collective - Household Survey (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.

Recruiting

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Key information

Age range

1 day–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Cohort Pregnancy Ratio

    Time frame: enrollment - 36 months

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

  2. Cohort Term Live Birth Ratio

    Time frame: 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.

  3. Cohort Infant Mortality Ratio

    Time frame: enrollment - 36 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mutale Sampa

CONTACT

[email protected]

+260977287091

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • University of Zambia

Registry information

Acronym: ARCH

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 13, 2021
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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