Treatment of Bacterial Vaginosis Prior to Active Labor an... | NCT03954990

Studies
Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

NCT03954990

Sponsor

The University of Texas Medical Branch, Galveston

Status

Terminated

Last Update Posted

Dec 12, 2023Actual

Enrollment

75Actual

Phase

Phase 1

Conditions

Bacterial Vaginoses

Interventions

Metronidazole Oral
Placebo Oral Tablet

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of significance/futile study

Expanded Access Info

Start Date

Oct 11, 2019Actual

Primary Completion Date

Sep 26, 2022Actual

Completion Date

Sep 26, 2022Actual

First Submitted Date

Apr 23, 2019

First Submission Date that Met QC Criteria

May 16, 2019

First Posted Date

May 17, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2023

Last Update Posted Date

Dec 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Arm	Placebo Comparator	Placebo tablets oral, 4 tablets once.	Drug: Placebo Oral Tablet
Treatment Arm	Active Comparator	Will receive 4 tablets (2g) of metronidazole oral once.	Drug: Metronidazole Oral

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metronidazole Oral	Drug	4 tablets (2 g of metronidazole)	Treatment Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Composite outcome of maternal infections	Including Chorioamnionitis, postpartum endometritis, wound infection, pelvic septic thrombosis, pelvic or abdominal abscess	Labor to 4 weeks postpartum

Secondary Outcomes

Measure	Description	Time Frame
Rate of Chorioamnionitis	Presumptive or confirmed diagnosis	From beginning of labor process until time of delivery
Rate of Postpartum Endometritis	Postpartum intrauterine infection

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sangeeta Jain, MD	University of Texas medical branch, Galveston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Medical Branch		Galveston	Texas	77555	United States

Condition Browse Module

MeSH Terms

ID	Term
D016585	Vaginosis, Bacterial

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008795	Metronidazole

Ancestor Terms

ID	Term
D009593	Nitroimidazoles
D009574	Nitro Compounds
D009930	Organic Chemicals
D007093	Imidazoles

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention 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.