Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

Bacterial Vaginoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03954990
• Other study ID #: 18-0103
• Status: Terminated
• Phase: Phase 1
• Start date: October 11, 2019
• Est. completion date: September 26, 2022

Study information

• Verified date: December 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: September 26, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginoses
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• Metronidazole Oral
4 tablets (2 g of metronidazole)
• Placebo Oral Tablet
4 tablets

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Chorioamnionitis	Presumptive or confirmed diagnosis	From beginning of labor process until time of delivery
Secondary	Rate of Postpartum Endometritis	Postpartum intrauterine infection	From time of delivery to 4 weeks postpartum
Secondary	Rate of Surgical Site Infection	Including superficial or deep incisional surgical site infection	4 weeks postpartum
Secondary	Rate of Pelvic Septic Thrombosis	Infection and thrombosis of pelvic vessels	4 weeks postpartum
Secondary	Rate of Pelvic abscess	Detection of pelvic abscess on imaging	4 weeks postpartum
Secondary	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
Secondary	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
Secondary	Rate of additional postpartum procedures	Additional imaging and invasive procedures to diagnose or treat postpartum infections	4 weeks postpartum
Secondary	Rate of Postpartum Antibiotics use	Number of patients requiring antibiotics secondary to postpartum infections	4 weeks postpartum
Secondary	Rate of ER and unscheduled postpartum clinic visit	Number of unscheduled clinic visits and ER visits secondary to infections.	4 weeks postpartum
Secondary	Number of days of hospital stay postpartum	Number of days patients admitted to the hospital secondary to infections postpartum	4 weeks postpartum
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of Neonatal morbidities	Including Respiratory Distress syndrome(RDS), Necrotizing enterocolitis(NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD)	90 days after delivery