Skip to main content
OpenTrials
Completed

NCT Number: NCT04955717

Antenatal Chlamydia Trachomatis and Neisseria Gonorrhoeae Testing to Prevent Adverse Neonatal Consequences

To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chlamydia Trachomatis Infection Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Neonatal Infection Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Birth Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

DHMT Clinics, Gaborone, Botswana

Loading trial locations.

About this study

In this study investigators are conducting a two-arm, cluster randomized trial to assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs). Investigators will enroll 500 asymptomatic pregnant women in the testing and treatment clinics, and they will receive CT and NG testing and appropriate treatment at their first antenatal care visit and at a visit during their third trimester. An additional 250 asymptomatic pregnant women will be enrolled in the standard of care clinics, and they will receive syndromic management with additional support for partner notification. All participants will be tested for CT and NG at the first postnatal visit and those who test positive will be offered infant testing. Investigators will determine if antenatal testing and treatment reduces maternal infections at delivery, preterm birth, low birth weight, and neonatal CT/NG infection. This study will provide evidence to help evaluate the effects of testing on vertical transmission and clinically important pregnancy neonatal health outcomes, and to evaluate and understand biological correlates of transmission.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 15 years,
  • Currently pregnant,
  • Attending first ANC visit,
  • 27 weeks gestation or less
  • Not currently experiencing CT/NG-related symptoms (determined by validated screening tool),
  • Not treated for CT/NG in the past 30 days,
  • Willingness to provide self-collected specimens for CT/NG testing (for the STI-testing group, this will take place at their first ANC visit, at another visit in their third trimester, and at postnatal care. For the standard of care group, samples will only be collected at postnatal care),
  • Willingness to return for a test of cure if CT/NG test is positive during antenatal care,
  • Will reside in Gaborone through the time of delivery and 1st postnatal visit,
  • Willingness to have neonates tested for CT/NG at their first postnatal visit,
  • Mentally competent to understand the informed consent.

Exclusion criteria

  • Not mentally competent to understand study procedures or give informed consent,
  • Individuals < 15 years,
  • Men,
  • Women who are not pregnant,
  • Pregnant women not attending their first antenatal visit,
  • Pregnant women at >27 weeks gestation
  • Pregnant women with current STI-related symptoms (will receive standard of care),
  • Treated for an STI in the past 30 days.

Treatment and study plan

Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert

Other

Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert

Primary outcomes

  1. Number of Women Diagnosed With C. Trachomatis and N. Gonorrhoeae Infection at Post-delivery

    Time frame: This outcome was assessed at the first postnatal care visit up to 12 weeks after delivery.

    Results from GeneXpert PCR screening for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (NG) infection among postpartum women up 12 weeks after birth outcome. We compare the proportion with CT and/or NG in both study arms

Secondary outcomes

  1. Number of Neonates Diagnosed With Chlamydia Trachomatis or Neisseria Gonorrhoeae Infection at Post-delivery.

    Time frame: This outcome will be assessed at the first postnatal care visit up to 12 weeks after delivery.

    Infants of mothers who tested positive for Chlamydia trachomatis or Neisseria gonorrhoeae infection at the first postnatal care visit will be tested using the GeneXpert PCR. We will compare the number of infected neonates between two arms.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Botswana Harvard AIDS Institute Partnership
  • University of California, San Diego

Registry information

Official study title

The Diagnosis and Treatment of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Pregnant Women to Prevent Adverse Neonatal Consequences.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 9, 2021
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.