Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity: A Randomized Controlled Trial

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

Study Overview

• Status: Terminated
• Conditions: Bacterial Vaginoses
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Metronidazole Oral

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm; Placebo tablets oral, 4 tablets once.	Drug: Placebo Oral Tablet; 4 tablets
Active Comparator: Treatment Arm; Will receive 4 tablets (2g) of metronidazole oral once.	Drug: Metronidazole Oral; 4 tablets (2 g of metronidazole); Other Names: Flagyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	From time of delivery to 4 weeks postpartum
Rate of Surgical Site Infection	Including superficial or deep incisional surgical site infection	4 weeks postpartum
Rate of Pelvic Septic Thrombosis	Infection and thrombosis of pelvic vessels	4 weeks postpartum
Rate of Pelvic abscess	Detection of pelvic abscess on imaging	4 weeks postpartum
Rate of Puerperal fever	Temperature of ≥ 100.4 F at least twice 30 minutes apart or once ≥ 101F	From beginning of labor process until time of delivery
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.	During labor and up to 4 weeks postpartum
Rate of additional postpartum procedures	Additional imaging and invasive procedures to diagnose or treat postpartum infections	4 weeks postpartum
Rate of Postpartum Antibiotics use	Number of patients requiring antibiotics secondary to postpartum infections	4 weeks postpartum
Rate of ER and unscheduled postpartum clinic visit	Number of unscheduled clinic visits and ER visits secondary to infections.	4 weeks postpartum
Number of days of hospital stay postpartum	Number of days patients admitted to the hospital secondary to infections postpartum	4 weeks 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)	4 weeks postpartum
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.	7 days of delivery
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.	7 days of delivery
Rate of Neonatal morbidities	Including Respiratory Distress syndrome(RDS), Necrotizing enterocolitis(NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD)	90 days after delivery

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Sangeeta Jain, MD, University of Texas medical branch, Galveston

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2019
• Primary Completion (Actual): September 26, 2022
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Bacterial Vaginoses in pregnancy
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: 18-0103

Drug and device information, study documents

• 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