A Phase 2 interventional study of oral versus vaginal metronidazole in Vaginosis, Bacterial, Premature Birth and Birth Weight, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in United States. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Centers for Disease Control and Prevention · Phase 2, Interventional, and Treatment
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:
This is a randomized, placebo-controlled intervention trial. Women diagnosed as BV+ by Gram stain at 12-16 weeks gestation are randomly assigned to the following treatment groups: oral metronidazole (250 mg TID x 7 days) with intravaginal placebo; intravaginal metronidazole (5g 0.75% gel BID x 5 days) with oral placebo. African American, Hispanic, Asian/Pacific Islander, Native American, and white women are eligible. Women with a prior preterm delivery, multiple gestation, chronic hypertension or pre-existing diabetes, antibiotic use before enrollment in the study, allergy to metronidazole, history of alcohol abuse in past year, and women under age 18 are excluded.
240 studies on the registry are indexed under Vaginosis, Bacterial; 39 are open to participants now.
This study's enrollment of 126 is above the median of 100 across 203 interventional studies indexed under Vaginosis, Bacterial.
Browse Vaginosis, Bacterial studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
oral (250mg three times daily for 7 days) metronidazole
Drug: oral versus vaginal metronidazole
intravaginal (5 g of 0.75% gel twice daily for 5 days) metronidazole
Drug: oral versus vaginal metronidazole
Microbiological, Clinical, and Therapeutic Cure Rates at Follow-Up among Women Treated with Oral vs. Intravaginal Metronidazole
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
Time frame: 4 weeks after treatment
preterm delivery
rate of delivery before 37 completed weeks gestation in intervention groups
Time frame: at delivery
low birth weight
birth weight less than 2500 grams
Time frame: at delivery
Plan to share: No
The record gives a start of Oct 1999, a primary completion of Sep 2004 and a completion of Sep 2004. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centers for Disease Control and Prevention →