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NCT02353117 · ClinicalTrials.gov registry record · NA

Preventing Congenital Syphilis

A NA study, sponsored by Tulane University School of Public Health and Tropical Medicine.

Completed
Registry status
NA
Development phase
60,386
Enrollment target

NCT02353117 is a NA study that has completed, run by Tulane University School of Public Health and Tropical Medicine. The registered enrollment target is 60,386 participants.

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The verdict

NCT02353117, a NA study, has completed, sponsored by Tulane University School of Public Health and Tropical Medicine.

COMPLETED
Registry status
NA
Development phase
60,386 participants
Enrollment target

Study Summary

Nearly 1.5 million pregnant women are infected with syphilis each year, and it is estimated that half of them will have adverse birth outcomes. Congenital syphilis remains a major public health issue, despite the fact that maternal syphilis is easy to detect and treat. Multiple barriers impair the elimination of congenital syphilis. Syphilis is often stigmatized and of low priority, and even women attending prenatal care early are potentially facing multiple clinical barriers. The study objective is to use implementation research methods to evaluate a multifaceted intervention to increase the use of evidence-based clinical procedures to prevent congenital syphilis. The investigators will perform a facility-based, two-arm parallel cluster randomized implementation trial in the Democratic Republic of the Congo and Zambia. The intervention will be multifaceted, tailored by formative research, and include: opinion leaders, reminders, monitoring, and feedback; point-of-care rapid tests; and treatment kits to be used immediately if the rapid test is positive. Improving syphilis screening and treatment will be promoted as a key step toward improving the quality of all components of prenatal care.

Interventions

  • BEHAVIORAL Congenital Syphilis Intervention Group

Trial Details

FieldValue
Enrollment Target 60,386 participants
Start Date 2016-01-11
Est. Completion 2018-02-28
Phase NA

What the Registry Record Tells You About NCT02353117

The ClinicalTrials.gov registry entry for NCT02353117 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 60,386 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tulane University School of Public Health and Tropical Medicine, which has 6 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Congenital Syphilis Intervention Group is the first listed.

NCT02353117 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02353117 about?

NCT02353117 is a clinical study titled "Preventing Congenital Syphilis". Nearly 1.5 million pregnant women are infected with syphilis each year, and it is estimated that half of them will have adverse birth outcomes. Congenital syphilis remains a major public health issue, despite the fact that maternal syphilis is easy to detect and treat. Multiple barriers impair the e...

What is the current status of trial NCT02353117?

This trial is currently completed. It is a NA study. The enrollment target is 60,386 participants. The study started on 2016-01-11. Estimated completion is 2018-02-28.

What interventions are being tested in trial NCT02353117?

The interventions under investigation include: Congenital Syphilis Intervention Group (BEHAVIORAL).

Who is sponsoring clinical trial NCT02353117?

This trial is sponsored by Tulane University School of Public Health and Tropical Medicine, which has 6 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.