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Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

NCT00153517 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-05-29

No results posted yet for this 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.

Conditions

  • Vaginosis, Bacterial
  • Premature Birth
  • Birth Weight
  • Chorioamnionitis

Interventions

DRUG

oral versus vaginal metronidazole

Sponsors & Collaborators

Principal Investigators

  • Jane E Hitti, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-10-31
Primary Completion
2004-09-30
Completion
2004-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00153517 on ClinicalTrials.gov