Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153517
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2005-09-08
Brief Title:
Maternal Effects of Bacterial Vaginosis BV Treatment in Pregnancy
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Maternal Effects of Bacterial Vaginosis BV Treatment in Pregnancy Randomized Trial of BV Treatment in Pregnancy
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 075 gel BID x 5 days with oral placebo African American Hispanic AsianPacific 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U36CCU300430-1179 | OTHER_GRANT | CDC | None |
| U36CCU300430-2239 | OTHER_GRANT | None | None |