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Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

Primary Purpose

Bacterial Vaginoses

Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Metronidazole Oral
Placebo Oral Tablet
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Vaginoses focused on measuring Bacterial Vaginoses in pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women ≤50 years at the time of admission with the ability to give informed con-sent.
  • Admission for induction of labor or early spontaneous labor with cervix ≤3 cm.
  • Diagnosed with bacterial vaginosis at time of admission or in the week prior to admission if not treated
  • Gestational age ≥ 34 weeks

Exclusion Criteria:

  • Spontaneous rupture of membranes
  • Plan for elective cesarean delivery
  • Allergy or contraindications to metronidazole
  • Receipt of metronidazole or clindamycin in the admission for delivery for other in-dications.
  • Hemodialysis
  • Severe liver dysfunction
  • Diagnosis of chorioamnionitis at the time of admission

Sites / Locations

  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control Arm

Treatment Arm

Arm Description

Placebo tablets oral, 4 tablets once.

Will receive 4 tablets (2g) of metronidazole oral once.

Outcomes

Primary Outcome Measures

Rate of Composite outcome of maternal infections
Including Chorioamnionitis, postpartum endometritis, wound infection, pelvic septic thrombosis, pelvic or abdominal abscess

Secondary Outcome Measures

Rate of Chorioamnionitis
Presumptive or confirmed diagnosis
Rate of Postpartum Endometritis
Postpartum intrauterine infection
Rate of Surgical Site Infection
Including superficial or deep incisional surgical site infection
Rate of Pelvic Septic Thrombosis
Infection and thrombosis of pelvic vessels
Rate of Pelvic abscess
Detection of pelvic abscess on imaging
Rate of Puerperal fever
Temperature of ≥ 100.4 F at least twice 30 minutes apart or once ≥ 101F
Rate of Maternal Death
Death of mother while pregnant or within 28 days of pregnancy termination from any cause related to pregnancy or its management.
Rate of additional postpartum procedures
Additional imaging and invasive procedures to diagnose or treat postpartum infections
Rate of Postpartum Antibiotics use
Number of patients requiring antibiotics secondary to postpartum infections
Rate of ER and unscheduled postpartum clinic visit
Number of unscheduled clinic visits and ER visits secondary to infections.
Number of days of hospital stay postpartum
Number of days patients admitted to the hospital secondary to infections postpartum
Rate of Adverse events
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), Gastrointestinal symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc)
Rate of Confirmed neonatal sepsis
Findings indicating positive cultures of blood, cerebrospinal fluid or urine obtained by catheterization or suprapubic aspiration, or cardiovascular collapse, or an unequivocal X-ray confirming infection in a clinically septic neonate.
Rate of Suspected neonatal sepsis
Presence of clinical signs/symptoms (hypothermia, fever, irritability, poor feeding, hypotonia, etc) causing the clinician to perform a sepsis work-up (blood, urine and/or cerebrospinal fluid, or chest X-ray), excludes routine work-up solely for positive maternal Group B Streptococcus (GBS) status.
Rate of Neonatal morbidities
Including Respiratory Distress syndrome(RDS), Necrotizing enterocolitis(NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD)

Full Information

First Posted
April 23, 2019
Last Updated
November 10, 2022
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT03954990
Brief Title
Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity
Official Title
Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Lack of significance/futile study
Study Start Date
October 11, 2019 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities
Detailed Description
The investigators are proposing a double-blinded, placebo controlled, randomized trial of 525 pregnant women undergoing induction or admitted in early labor and who are diagnosed with bacterial vaginosis. On admission to labor and delivery, patient will be counseled about the study. Patients who agree to be enrolled, will sign informed consent. Following enrollment patients will be screened for Bacterial vaginosis by doing a speculum exam and testing for Amsel's criteria. BV +ve patients will be randomized to receive either metronidazole 2 grams PO once or identically appearing placebo. The PI, study coordinator, or a collaborator will be responsible for the informed consent. This will be a double-blinded randomized clinical trial. Neither the patient nor provider will be aware of treatment assignment. As with any other in-stance in which antibiotics are administered, there is a chance of an allergic or other adverse reaction. The patient will receive standard inpatient monitoring during the labor course and in the postpartum period, and so any immediate adverse reaction would be promptly detected. Patient will be assessed intrapartum for development of chorioamninoitis. Postpartum patient will be assessed for infective complications up to 4 weeks. Neonates will be assessed for morbidities by chart review for 90 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginoses
Keywords
Bacterial Vaginoses in pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Patient with bacterial vaginosis will be randomized to either treatment group to receive 2 g of metronidazole or control group to receive 2 g of placebo. Randomization to either control or treatment group will be done according to a randomization sequence that is computer generated and maintained by investigational drug pharmacy.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Patients, providers, PI, investigators will be blinded.
Allocation
Randomized
Enrollment
525 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Placebo tablets oral, 4 tablets once.
Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
Will receive 4 tablets (2g) of metronidazole oral once.
Intervention Type
Drug
Intervention Name(s)
Metronidazole Oral
Other Intervention Name(s)
Flagyl
Intervention Description
4 tablets (2 g of metronidazole)
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
4 tablets
Primary Outcome Measure Information:
Title
Rate of Composite outcome of maternal infections
Description
Including Chorioamnionitis, postpartum endometritis, wound infection, pelvic septic thrombosis, pelvic or abdominal abscess
Time Frame
Labor to 4 weeks postpartum
Secondary Outcome Measure Information:
Title
Rate of Chorioamnionitis
Description
Presumptive or confirmed diagnosis
Time Frame
From beginning of labor process until time of delivery
Title
Rate of Postpartum Endometritis
Description
Postpartum intrauterine infection
Time Frame
From time of delivery to 4 weeks postpartum
Title
Rate of Surgical Site Infection
Description
Including superficial or deep incisional surgical site infection
Time Frame
4 weeks postpartum
Title
Rate of Pelvic Septic Thrombosis
Description
Infection and thrombosis of pelvic vessels
Time Frame
4 weeks postpartum
Title
Rate of Pelvic abscess
Description
Detection of pelvic abscess on imaging
Time Frame
4 weeks postpartum
Title
Rate of Puerperal fever
Description
Temperature of ≥ 100.4 F at least twice 30 minutes apart or once ≥ 101F
Time Frame
From beginning of labor process until time of delivery
Title
Rate of Maternal Death
Description
Death of mother while pregnant or within 28 days of pregnancy termination from any cause related to pregnancy or its management.
Time Frame
During labor and up to 4 weeks postpartum
Title
Rate of additional postpartum procedures
Description
Additional imaging and invasive procedures to diagnose or treat postpartum infections
Time Frame
4 weeks postpartum
Title
Rate of Postpartum Antibiotics use
Description
Number of patients requiring antibiotics secondary to postpartum infections
Time Frame
4 weeks postpartum
Title
Rate of ER and unscheduled postpartum clinic visit
Description
Number of unscheduled clinic visits and ER visits secondary to infections.
Time Frame
4 weeks postpartum
Title
Number of days of hospital stay postpartum
Description
Number of days patients admitted to the hospital secondary to infections postpartum
Time Frame
4 weeks postpartum
Title
Rate of Adverse events
Description
Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), Gastrointestinal symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc)
Time Frame
4 weeks postpartum
Title
Rate of Confirmed neonatal sepsis
Description
Findings indicating positive cultures of blood, cerebrospinal fluid or urine obtained by catheterization or suprapubic aspiration, or cardiovascular collapse, or an unequivocal X-ray confirming infection in a clinically septic neonate.
Time Frame
7 days of delivery
Title
Rate of Suspected neonatal sepsis
Description
Presence of clinical signs/symptoms (hypothermia, fever, irritability, poor feeding, hypotonia, etc) causing the clinician to perform a sepsis work-up (blood, urine and/or cerebrospinal fluid, or chest X-ray), excludes routine work-up solely for positive maternal Group B Streptococcus (GBS) status.
Time Frame
7 days of delivery
Title
Rate of Neonatal morbidities
Description
Including Respiratory Distress syndrome(RDS), Necrotizing enterocolitis(NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD)
Time Frame
90 days after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women ≤50 years at the time of admission with the ability to give informed con-sent. Admission for induction of labor or early spontaneous labor with cervix ≤3 cm. Diagnosed with bacterial vaginosis at time of admission or in the week prior to admission if not treated Gestational age ≥ 34 weeks Exclusion Criteria: Spontaneous rupture of membranes Plan for elective cesarean delivery Allergy or contraindications to metronidazole Receipt of metronidazole or clindamycin in the admission for delivery for other in-dications. Hemodialysis Severe liver dysfunction Diagnosis of chorioamnionitis at the time of admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeeta Jain, MD
Organizational Affiliation
University of Texas medical branch, Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

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Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

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