Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

Not Applicable

Terminated

• Conditions: Infection; Endometritis; Cesarean Delivery Affecting Fetus; Wounds Injuries; Obstetric Labor Complications
• Interventions: Procedure: Vaginal Preparation

• Registration Number: NCT04163679
• Lead Sponsor: Womack Army Medical Center

Brief Summary

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Detailed Description

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Study Timeline

• Study Start: 2019-09-18
• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal Preparation	Vaginal Preparation	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.
Standard Infection Procedures	Vaginal Preparation	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.

Primary Outcome Measures

Name	Time	Method
Infection rates	six weeks postpartum	endometritis

Secondary Outcome Measures

Name	Time	Method
Infant Birth Weight	Four weeks after birth	record their birth weight (gm)
Infant Apgar scores	Four weeks after birth	Apgar scores
Infant Length of hospital stay	Four weeks after birth	Hospital stay (days)
Numbers of Infants admitted to NICU	four weeks after birth	Infant admission to neonatal intensive care unit
Number of Infants that develop respiratory distress	Four weeks after birth	The infant acquiring the condition of respiratory distress
Number of Infants that develop sepsis	Four weeks after birth	Infant acquiring sepsis
Number of infants that die	Four weeks after birth	Infant death

Trial Locations

Locations (1)

Womack Army Medical Center; 🇺🇸 Fort Bragg, North Carolina, United States