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

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, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (4204% higher). According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT02353117 record still lists

NCT02353117 is an interventional study that assigns participants to a tested intervention. Its 60,386 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (4204% higher).

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

NCT02353117 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02353117's enrollment target sits among peer trials

60,386 6th of 2000 higher than 1,995 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02353117, the US trial registry maintained by the National Library of Medicine. NCT02353117 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.