ANC COVID-19 Surveillance

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

9111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-06

Study Completion Date

2023-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Detection Performance of the N Antigenemia of SARS-CoV-2 in the General Population for the Diagnosis and Screening of COVID-19

NCT05092607

Respiratory Viral Infection

UNKNOWN NA

Assessment of Obstetric, Fetal and Neonatal Risks and Vertical SARS-CoV-2 Transmission During COVID-19 Pandemic

NCT04360811

Pregnancy

COMPLETED NA

Screening for Hepatitis C During Pregnancy at a Toronto Inner City Prenatal Clinic

NCT00348660

Hepatitis C Pregnancy

COMPLETED

Prevalence and Impact of COVID-19 Infection in Pregnant Women, Fetuses and Newborns

NCT04355234

Pregnancy

COMPLETED NA

Evaluating Clinical Parameters of COVID-19 in Pregnancy

NCT04470583

COVID-19 2019 Novel Coronavirus Infection COVID-19 Infection

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This surveillance platform may be able to provide key information on the spread of the SARS-CoV-2 virus through the general population. By using serologic testing to understand trends in the proportion of pregnant women over time who were exposed to SARS-CoV-2, we will be able to understand not only the ultimate proportion of pregnant women who were ever infected, but also be able to track and potentially detect outbreaks (e.g. in areas with increasing positivity rates), unlike data that would be available from a single cross-sectional survey, which could give the overall prevalence at a single point in time.

Zambia is experiencing a SARS-CoV-2 epidemic. From March 18, 2020 to February 19, 2021, at total of 73,203 confirmed cases have been reported in Zambia. However, the true number is likely much larger, because surveillance systems for SARS-CoV-2 in Zambia are incomplete.

Since 2020, the coronavirus disease has become a major public health concern and sustainable and efficient surveillance platforms are urgently needed; assessing women attending 1st ANC should provide insights into transmission trends in the general population. This activity will determine what proportion of pregnant women demonstrate evidence of SARS-CoV-2 infection over time. The findings of this research may be used to change the way health system monitors the epidemic and ensures health services are made available with minimal disruptions.

The study was implemented at 39 public health facilities. A sample of 20 pregnant women attending their first ANC visit at the selected study sites will be enrolled into the study until the monthly sample size is reached.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

SARS-CoV-2 Seroprevalence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes