Antenatal and Postnatal Care Research Collective

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-29

Study Completion Date

2026-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Maternal Health Pregnancy Outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women of reproductive age

Women 15-49 years of age

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Women of reproductive age eligibility 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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes