Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

Womack Army Medical Center (WAMC)

Status: Terminated

Conditions: Infection; Cesarean Delivery Affecting Fetus; Obstetric Labor Complications; Wounds Injuries; Endometritis

Treatments: Procedure: Vaginal Preparation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04163679

RHC-A-19-033

Details and patient eligibility

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Full description

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Enrollment: 84 patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• full term pregnancy
• undergoing labored, non-emergent cesarean section
• patient in labor

Exclusion criteria

Azithromycin contraindicated:

• Known hypersensitivity to azithromycin, erythromycin, macrolides or ketolide medications.
• liver dysfunction
• Prescription medications which may interact with azithromycin, such as nelfinavir or warfarin
• A history of a cardiac dysrhythmia (irregular heartbeats)
• Known hypersensitivity to iodine
• Patients carrying fetuses with known congenital anomalies
• Immunodeficiency
• Patients who are not in labor at the time of delivery
• Non-english speaking subjects or subjects with language barriers

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Vaginal Preparation

Experimental group

Description:

In addition to standard care, subjects will undergo vaginal preparation (VP). A VP kit includes sponge sticks and sponges soaked in a povidone-iodine 10% solution.

Treatment:

Procedure: Vaginal Preparation

Standard Infection Procedures

Sham Comparator group

Description:

The very staff will follow hospital protocols for the cesarean delivery. The subject and the infant will be provided care in accordance with current medical standards and be discharged at the discretion of the attending physician.

Treatment:

Procedure: Vaginal Preparation