Who is sponsoring NCT00153517?

NCT00153517 is sponsored by Centers for Disease Control and Prevention.

What condition does NCT00153517 study?

NCT00153517 studies Vaginosis, Bacterial, Premature Birth, Birth Weight, Chorioamnionitis.

What drugs are being tested in NCT00153517?

Interventions: oral versus vaginal metronidazole.

What is the status of NCT00153517?

NCT00153517 is currently COMPLETED.

Last reviewed 2024-05-28 · How we verify

Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy (Randomized Trial of BV Treatment in Pregnancy)

NCT00153517 Phase 2 COMPLETED

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.

Details

Lead sponsor	Centers for Disease Control and Prevention
Phase	Phase 2
Status	COMPLETED
Enrolment	126
Start date	1999-10
Completion	2004-09

Conditions

Vaginosis, Bacterial
Premature Birth
Birth Weight
Chorioamnionitis

Interventions

oral versus vaginal metronidazole

Primary outcomes

Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole — 4 weeks after treatment
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

Countries

United States