Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

NCT03954990 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 18-0103
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

Bacterial Vaginoses

Keywords

Bacterial Vaginoses in pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 (15)

• Rate of Chorioamnionitis

  From beginning of labor process until time of delivery

• Rate of Postpartum Endometritis

  From time of delivery to 4 weeks postpartum

• Rate of Surgical Site Infection

  4 weeks postpartum

• Rate of Pelvic Septic Thrombosis

  4 weeks postpartum

• Rate of Pelvic abscess

  4 weeks postpartum

Study Arms (2)

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

Metronidazole Oral DRUG

4 tablets (2 g of metronidazole)

Also known as: Flagyl

Treatment Arm

Placebo Oral Tablet DRUG

4 tablets

Control Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sangeeta Jain, MD

  University of Texas medical branch, Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients, providers, PI, investigators will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 17, 2019
• Study Start: October 11, 2019
• Primary Completion: September 26, 2022
• Study Completion: September 26, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

US (1)