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NCT00153517 · ClinicalTrials.gov registry record · Phase 2

Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

A Phase 2 study of Premature Birth and Birth Weight, sponsored by Centers for Disease Control and Prevention.

Completed
Registry status
Phase 2
Development phase
126
Enrollment target
1
Study location

NCT00153517: Completed Phase 2 study of Premature Birth and Birth Weight, sponsored by Centers for Disease Control and Prevention.

NCT00153517 is a Phase 2 study of Premature Birth and Birth Weight that has completed, run by Centers for Disease Control and Prevention. The registered enrollment target is 126 participants, below the 391-participant average among 38 other Premature Birth trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00153517, a Phase 2 study of Premature Birth and Birth Weight, has completed, sponsored by Centers for Disease Control and Prevention.

COMPLETED
Registry status
Phase 2
Development phase
126 participants
Enrollment target
1
Study location

Study Summary

The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are: 1. To examine the side effects and patient acceptability of oral versus intravaginal metronidazole. 2. To compare the efficacy of oral and intravaginal metronidazole for the treatment of BV 3. To study the efficacy of oral and intravaginal metronidazole for the prevention of hospital admission during the 3rd trimester, chorioamnionitis, preterm delivery, and maternal infectious morbidity.

Primary Outcome

Cure rates were assessed by Gram Stain Score (0-3, 4-6, 7-10); Abnormal clincial signs (0, 1-2, 3-4); Therapeutic cure (Gram Stain 0-3 and no symptoms) treatment

Interventions

  • DRUG oral versus vaginal metronidazole

Study Locations (1)

Washington

  • University of Washington - Seattle

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 1999-10
Est. Completion 2004-09
Phase Phase 2

What the finished NCT00153517 record still lists

NCT00153517 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 391-participant average among 38 other Premature Birth trials with a reported enrollment target (68% lower).

The record links to 4 conditions, with Premature Birth appearing as the primary indexed condition, and to 1 intervention - of which oral versus vaginal metronidazole is the first listed.

NCT00153517 reports a single indexed study location in Washington.

Frequently Asked Questions

What is clinical trial NCT00153517 about?

NCT00153517 is a clinical study titled "Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy". The goal of this study is to examine acceptability and efficacy of 2 kinds of BV treatment among women at low risk for preterm delivery. The objectives are: 1. To examine the side effects and patient acceptability of oral versus intravaginal metronidazole. 2. To compare the efficacy of oral and int...

What is the current status of trial NCT00153517?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 1999-10. Estimated completion is 2004-09.

What conditions does trial NCT00153517 study?

This clinical trial studies the following conditions: Premature Birth, Birth Weight, Chorioamnionitis, Vaginosis, Bacterial.

What interventions are being tested in trial NCT00153517?

The interventions under investigation include: oral versus vaginal metronidazole (DRUG).

Who is sponsoring clinical trial NCT00153517?

This trial is sponsored by Centers for Disease Control and Prevention, which has 139 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00153517 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Premature Birth

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00153517's enrollment target sits among peer trials

126 17th of 38 higher than 22 of 38 other Premature Birth trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Premature Birth 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 NCT00153517, the US trial registry maintained by the National Library of Medicine. NCT00153517 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.