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After screening many patients for BV, it was determined that the rate of BV is less in our population that the 30% rate mentioned in the literature. It was determined that completing the study will not be feasible due to cost and time constraints.
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This is a double-blinded, placebo controlled, multi-center randomized trial of 482 pregnant women who are diagnosed with Bacterial Vaginosis (BV) in the late 3rd trimester (>34 weeks). During routine clinic visit after 34 weeks, prospective patients will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment, patients will be screened for BV. Those patients who are BV positive by clinical diagnosis, will be randomized to receive either metronidazole 500 mg BID orally for 7 days or identically appearing placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole 500 mg | Active Comparator | Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days |
|
| Placebo | Placebo Comparator | Participants in this arm will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery) | Through study completion, approximately 9.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating Incidence of Individual Infections. | Chorioamnionitis, endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection. | At the time of admission for labor trough study completion, approximately 9.5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine | Columbus | Ohio | 43210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metronidazole 500 mg | Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days Metronidazole: Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days |
| FG001 | Placebo | Participants in this arm will receive placebo Placebo: Participants in this arm will receive placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline analysis population data was not obtained as participants assigned to the treatment and placebo group did not complete the study, and this study was terminated due to lack of participant enrollment before data could be collected. No baseline data was collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Metronidazole 500 mg | Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days Metronidazole: Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluating Composite of Chorioamnionitis, Postpartum Endometritis, SSI, Wound Infection, or Other Post-cesarean Infections (Occurring Within 6 Weeks After Delivery) | Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study. | Posted | Through study completion, approximately 9.5 months |
|
Through study termination
No adverse events were observed prior to termination of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metronidazole 500 mg | Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days Metronidazole: Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kartik Venkatesh, MD, PhD | The Ohio State University | 614-293-2222 | kartik.venkatesh@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2021 | Mar 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| D013530 | Surgical Wound Infection |
| D004716 | Endometritis |
| D007239 | Infections |
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Placebo | Drug | Participants in this arm will receive placebo |
|
| Evaluating Incidence of Maternal Death |
| After delivery through study completion, approximately 9.5 months |
| Evaluating Incidence of Puerperal Fever. | Temperature > 100.4 F at least twice 30 minutes apart, or once with the use of antipyretic, or ≥101 F once. | Through study completion, approximately 9.5 months |
| Evaluating Incidence of Use of Resources. | Hospital stay, postpartum clinic or emergency room visit within 4 weeks of delivery, need for imaging or other invasive procedures, postpartum antibiotic use. | Through study completion, approximately 9.5 months |
| Evaluating Incidence of Adverse Events | Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), GI symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc) | Through study completion, approximately 9.5 months |
| Evaluating Incidence of Suspected Sepsis for Newborns | Within 7 days of delivery |
| Evaluating Incidence of Confirmed Sepsis for Newborns | Within 7 days of delivery |
| Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration | After delivery through study completion, approximately 9.5 months |
| Evaluating Incidence of Neonatal Morbidities | After delivery through study completion, approximately 9.5 months |
Participants in this arm will receive placebo Placebo: Participants in this arm will receive placebo |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
|
|
| Secondary | Evaluating Incidence of Individual Infections. | Chorioamnionitis, endometritis, wound infection (including necrotizing fascitis), other infections including abscess, septic thrombosis, pneumonia, pyelonephritis and breast infection. | Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study. | Posted | At the time of admission for labor trough study completion, approximately 9.5 months |
|
|
| Secondary | Evaluating Incidence of Maternal Death | Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study. | Posted | After delivery through study completion, approximately 9.5 months |
|
|
| Secondary | Evaluating Incidence of Puerperal Fever. | Temperature > 100.4 F at least twice 30 minutes apart, or once with the use of antipyretic, or ≥101 F once. | Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study. | Posted | Through study completion, approximately 9.5 months |
|
|
| Secondary | Evaluating Incidence of Use of Resources. | Hospital stay, postpartum clinic or emergency room visit within 4 weeks of delivery, need for imaging or other invasive procedures, postpartum antibiotic use. | Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study. | Posted | Through study completion, approximately 9.5 months |
|
|
| Secondary | Evaluating Incidence of Adverse Events | Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), GI symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc) | Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study. | Posted | Through study completion, approximately 9.5 months |
|
|
| Secondary | Evaluating Incidence of Suspected Sepsis for Newborns | Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study. | Posted | Within 7 days of delivery |
|
|
| Secondary | Evaluating Incidence of Confirmed Sepsis for Newborns | Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study. | Posted | Within 7 days of delivery |
|
|
| Secondary | Evaluating Incidence of Newborn Intensive Care Unit (NICU) Admission and Duration | Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study. | Posted | After delivery through study completion, approximately 9.5 months |
|
|
| Secondary | Evaluating Incidence of Neonatal Morbidities | Study outcomes were not collected as no participants completed either the intervention or control study group. Participation was terminated before completion of the study. | Posted | After delivery through study completion, approximately 9.5 months |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Placebo | Participants in this arm will receive placebo Placebo: Participants in this arm will receive placebo | 0 | 8 | 0 | 8 | 0 | 8 |
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| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000292 | Pelvic Inflammatory Disease |
| D000291 | Adnexal Diseases |
| D014591 | Uterine Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |