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Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity

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ClinicalTrials.gov Identifier: NCT03954990
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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

Condition or disease Intervention/treatment Phase
Bacterial Vaginoses Drug: Metronidazole Oral Drug: Placebo Oral Tablet Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patients, providers, PI, investigators will be blinded.
Primary Purpose: Treatment
Official Title: Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity: A Randomized Controlled Trial
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

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 Name: Flagyl




Primary Outcome Measures :
  1. Rate of Composite outcome of maternal infections [ Time Frame: Labor to 4 weeks postpartum ]
    Including Chorioamnionitis, postpartum endometritis, wound infection, pelvic septic thrombosis, pelvic or abdominal abscess


Secondary Outcome Measures :
  1. Rate of Chorioamnionitis [ Time Frame: From beginning of labor process until time of delivery ]
    Presumptive or confirmed diagnosis

  2. Rate of Postpartum Endometritis [ Time Frame: From time of delivery to 4 weeks postpartum ]
    Postpartum intrauterine infection

  3. Rate of Surgical Site Infection [ Time Frame: 4 weeks postpartum ]
    Including superficial or deep incisional surgical site infection

  4. Rate of Pelvic Septic Thrombosis [ Time Frame: 4 weeks postpartum ]
    Infection and thrombosis of pelvic vessels

  5. Rate of Pelvic abscess [ Time Frame: 4 weeks postpartum ]
    Detection of pelvic abscess on imaging

  6. Rate of Puerperal fever [ Time Frame: From beginning of labor process until time of delivery ]
    Temperature of ≥ 100.4 F at least twice 30 minutes apart or once ≥ 101F

  7. Rate of Maternal Death [ Time Frame: During labor and up to 4 weeks postpartum ]
    Death of mother while pregnant or within 28 days of pregnancy termination from any cause related to pregnancy or its management.

  8. Rate of additional postpartum procedures [ Time Frame: 4 weeks postpartum ]
    Additional imaging and invasive procedures to diagnose or treat postpartum infections

  9. Rate of Postpartum Antibiotics use [ Time Frame: 4 weeks postpartum ]
    Number of patients requiring antibiotics secondary to postpartum infections

  10. Rate of ER and unscheduled postpartum clinic visit [ Time Frame: 4 weeks postpartum ]
    Number of unscheduled clinic visits and ER visits secondary to infections.

  11. Number of days of hospital stay postpartum [ Time Frame: 4 weeks postpartum ]
    Number of days patients admitted to the hospital secondary to infections postpartum

  12. Rate of Adverse events [ Time Frame: 4 weeks postpartum ]
    Allergic reactions (anaphylaxis, angioedema, skin rashes including Stevens Johnson and Toxic Epidermal necrolysis), Gastrointestinal symptoms (nausea, vomiting, diarrhea, constipation, ileus, etc)

  13. Rate of Confirmed neonatal sepsis [ Time Frame: 7 days of delivery ]
    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.

  14. Rate of Suspected neonatal sepsis [ Time Frame: 7 days of delivery ]
    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.

  15. Rate of Neonatal morbidities [ Time Frame: 90 days after delivery ]
    Including Respiratory Distress syndrome(RDS), Necrotizing enterocolitis(NEC), Intraventricular hemorrhage (IVH), Bronchopulmonary Dysplasia (BPD)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954990


Contacts
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Contact: Mauricio La Rosa, MD 2155180694 mauricio.la.rosa@gmail.com
Contact: Mahmoud Abdelwahab, MD 4094437239 abdelwahabm89@gmail.com

Locations
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United States, Texas
Universty of Texas Medical Branch
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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Principal Investigator: Mauricio La Rosa, MD University of Texas medical branch, Galveston

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03954990     History of Changes
Other Study ID Numbers: 18-0103
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: April 2019

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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

Keywords provided by The University of Texas Medical Branch, Galveston:
Bacterial Vaginoses in pregnancy

Additional relevant MeSH terms:
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Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents