ANC COVID-19 Surveillance

NCT07021807 | Completed

• 2 other identifiers: ANC COVID-19 SurveillanceNU2GGH002251
• Study Type: observational
• Target: 9,111
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this observational study is to determine the seroprevalence of SARS-CoV-2 antibodies in the community with pregnant women aged 15-49 years attending first antenatal care as the sentinel population. Further, the study seeks:

• To determine the feasibility and acceptability of SARS-CoV-2 antibody tests among pregnant women
• To estimate the prevalence of HIV-COVID 19 co-infection among pregnant women aged 15-49 years
• To determine sociodemographic factors associated with SARS-CoV-2 seropositivity among pregnant women
• To compare trends in seroprevalence among pregnant women with routine surveillance data to determine if ANC sentinel surveillance is a viable surveillance strategy for SARS-CoV-2 The main question it aims to answer is: \- What is the seroprevalence of antibodies to SARS-CoV-2 among pregnant women attending first ANC visit in Zambia? Participants will be expected to give consent to participating in the study on the day of their first antenatal visit. They should allow the collection of a dried blood spot for SARS-CoV-2 antibody test.

Conditions

SARS-CoV-2 Seroprevalence

Keywords

Prenatal care; Covid-19; SARS-CoV-2; sentinel surveillance; seroprevalence

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 seroprevalence

  Number of participants with a positive test result divided by the total number of participants with a valid test result by month and district.

  13 months

Secondary Outcomes (1)

• Vaccine Uptake

  13 months

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Females who are pregnant and registered for antenatal care.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

A sample of 20 pregnant women attending their first ANC visit at 39 study sites will be enrolled in the study until the monthly sample size is reached.

You may qualify if:

• Confirmed pregnant and are registered for their first ANC visit
• Aged 15 to 49 years
• Able to provide consent to participate and have blood sample collected for the SARS-CoV-2 antibody test

You may not qualify if:

• Not first ANC visit for the pregnant woman
• Women less than 15 years or above 49 years old
• Women not able to provide consent for study participation

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead

Study Sites (1)

Centre for Infectious Disease Research in Zambia

Lusaka, 10101, Zambia

Location

Related Publications (1)

• Oran DP, Topol EJ. Prevalence of Asymptomatic SARS-CoV-2 Infection : A Narrative Review. Ann Intern Med. 2020 Sep 1;173(5):362-367. doi: 10.7326/M20-3012. Epub 2020 Jun 3.

  PMID: 32491919 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: June 15, 2025
• Study Start: September 6, 2021
• Primary Completion: September 30, 2022
• Study Completion: March 30, 2023
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

ZA (1)