Maternal HealthARCHNCT05154331
Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)
An observational study of Maternal Health and Pregnancy Outcomes, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Maternal Health, Pregnancy Outcomes
- How many people
- 5,500 participants
- Where
- 1 siteZambia
- Study dates
- 29 Mar 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Women of reproductive age and their infants born during their study participation
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Maternal Health, Pregnancy Outcomes
- Keywords
- pregnancy health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women of reproductive age | Women 15-49 years of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort Pregnancy Ratio
Defined as the total number of pregnancies, including live births, stillbirths, and abortions per 1000 women aged 15-49.
Measured: 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.
Measured: 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.
Measured: enrollment - 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start29 Mar 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Zambia
- Responsible party
- Sponsor
- Investigators
- Jeff Stringer, Principal investigator, University of North Carolina, Chapel HillWilbroad Mutale, MD, Principal investigator, University of Zambia (UNZA) Lusaka, Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154331
- Sponsor's protocol ID
- 21-1370
- Acronym
- ARCH
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2021
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antenatal and Postnatal Care Research Collective - Household Survey (ARCH)
- ClinicalTrials.gov ID
- NCT05154331
- Acronym / sponsor ID
- ARCH / 21-1370
- Conditions
- Maternal Health, Pregnancy Outcomes
- Keywords
- pregnancy health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,500 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, University of Zambia
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women of reproductive age | – | –Women 15-49 years of age |
Who may qualify
- Ages
- 1 day to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women of reproductive age and their infants born during their study participation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Stringer principal investigator
University of North Carolina, Chapel Hill
Wilbroad Mutale, MD principal investigator
University of Zambia (UNZA) Lusaka, Zambia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Health and Pregnancy Outcomes, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort Pregnancy Ratio (time frame: enrollment - 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.