# The diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae in pregnant women to prevent adverse neonatal consequences

> **NIH NIH R21** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2020 · $202,822

## Abstract

PROJECT ABSTRACT
 Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are bacterial sexually transmitted
infections (STIs), and are neglected causes of adverse neonatal outcomes. According to WHO modelling
estimates, CT and NG infections are the most common STIs globally. These infections are even more common
among people living with HIV. The risk of vertical transmission during delivery is about 50%. HIV-infected
pregnant women with CT and/or NG infections are at increased risk of MTCT of HIV. Other studies on CT and
NG infections in neonates are over 20 years old and those infections are not systematically measured in sub-
Saharan Africa and are largely unknown.
 Few countries provide routine antenatal testing. In most countries, the syndromic approach is used,
which utilizes an algorithm to classify symptoms into STI syndromes and provide standardized treatment.
Syndromic management lacks specificity and causes pregnant women to be unnecessarily exposed to
antibiotics, and has low sensitivity, missing asymptomatic infections, putting neonates at risk.
 Our proposal has three specific aims. Aim 1: We will determine the burden of CT and NG infections and
correlates of infection among asymptomatic pregnant women in Gaborone, Botswana by a) using diagnostic
testing to estimate the prevalence of CT and NG infections at first and third trimester antenatal visits and
postnatal visit and the incidence of infections between those visits; and b) assessing the correlates of infection.
Aim 2: Will compare longitudinal neonatal outcomes for pregnant women tested for CT and NG infections with
women who received standard antenatal care by a) estimating the frequency of vertical transmission of CT and
NG infections and neonatal outcomes and the association with testing and treatment; and b) assessing
independent factors that may be predictive of adverse neonatal outcomes. Aim 3: We will assess the burden of
infection and markers of inflammatory response to CT and NG infection during pregnancy and associations
with vertical transmission of CT and NG by a) testing immunologic factors associated with vertical transmission
of CT and NG; b) determining the association between the Xpert® CT/NG assay's pathogen-specific cycle
threshold value (Ct) and transmission; and c) evaluating the frequency and distribution of Sample Adequacy
Control (SAC) cycle threshold values (Ct) from the Xpert® CT/NG assay, and evaluate any correlations with
the transmission of CT/NG to neonates.
 We will provide evidence to help evaluate the effects of testing on vertical transmission and clinically
important neonatal health outcomes, and to evaluate and understand biological correlates of transmission. This
study seeks to generate evidence to inform a larger R01 grant application.

## Key facts

- **NIH application ID:** 9875218
- **Project number:** 1R21HD100821-01
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** Jeffrey David Klausner
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $202,822
- **Award type:** 1
- **Project period:** 2020-02-22 → 2021-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9875218

## Citation

> US National Institutes of Health, RePORTER application 9875218, The diagnosis and treatment of Chlamydia trachomatis and Neisseria gonorrhoeae in pregnant women to prevent adverse neonatal consequences (1R21HD100821-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9875218. Licensed CC0.

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