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

Maternal Health Clinical Trial

— ARCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05154331
• Other study ID #: 21-1370
• Status: Recruiting
• Start date: March 29, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Mutale Sampa
• Phone: +260977287091
• Email: mutalesampa65[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 clinical covariates that contribute to adverse outcomes in each reproductive epoch.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7500
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Maternal Health
• Pregnancy Outcomes

Locations

Country	Name	City	State
Zambia	University of Zambia	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Bill and Melinda Gates Foundation, University of Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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