Maternal Effects of Bacterial Vaginosis (BV) Treatment in Pregnancy

Status Completed

Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00153517
Study type	Interventional
Source	Centers for Disease Control and Prevention
Contact
Status	Completed
Phase	Phase 2
Start date	October 1999
Completion date	September 2004

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05048550` - Babies in Glasses; a Feasibility Study.	N/A
Active, not recruiting	`NCT03655639` - Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
Enrolling by invitation	`NCT05542108` - Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants	N/A
Completed	`NCT03680157` - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed	`NCT03337659` - A Cluster Randomized Controlled Trial of FICare at 18 Months	N/A
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Completed	`NCT03251729` - Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix	Phase 4
Not yet recruiting	`NCT05039918` - Neonatal Experience of Social Touch	N/A
Not yet recruiting	`NCT03418311` - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome	N/A
Not yet recruiting	`NCT03418012` - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB	N/A
Completed	`NCT02913495` - Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth	Phase 4
Not yet recruiting	`NCT02880696` - Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates	N/A
Completed	`NCT02952950` - Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study	N/A
Completed	`NCT02661360` - Effects of Swaddling on Infants During Feeding	N/A
Completed	`NCT02743572` - Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants	N/A
Completed	`NCT02879799` - Family Integrated Care (FICare) in Level II NICUs	N/A
Completed	`NCT01352234` - Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia	Phase 4
Completed	`NCT01163188` - Social Adjustment and Quality of Life After Very Preterm Birth	N/A
Terminated	`NCT00675753` - Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families	N/A
Terminated	`NCT00179972` - Evaluation of Pulse Oximetry Sensors in Neonates	N/A