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NCT03640507 · ClinicalTrials.gov registry record · Phase 2
Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT03640507: Completed Phase 2 study, sponsored by Columbia University.
NCT03640507 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03640507, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to see whether chlorhexidine is superior to povidine-iodine vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and vaginal washing with saline alone.
Primary Outcome
Vaginal cultures are collected after the vaginal preparation intervention. These undergo serial dilutions and are incubated on Tryptic Soy Agar for seven days. Bacteria colony counts were determined by blinded investigators on day 7.
Interventions
- DRUG Sterile saline
- DRUG Chlorhexidine-alcohol
- DRUG Povidine-iodine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2019-06-14 |
| Phase | Phase 2 |
What the finished NCT03640507 record still lists
NCT03640507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Sterile saline is the first listed.
NCT03640507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03640507 about?
NCT03640507 is a clinical study titled "Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline". The purpose of this study is to see whether chlorhexidine is superior to povidine-iodine vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and vaginal washing with salin...
What is the current status of trial NCT03640507?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2018-10-01. Estimated completion is 2019-06-14.
What interventions are being tested in trial NCT03640507?
The interventions under investigation include: Sterile saline (DRUG), Chlorhexidine-alcohol (DRUG), Povidine-iodine (DRUG).
Who is sponsoring clinical trial NCT03640507?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03640507's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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