Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

October 6, 2021 updated by: Karen L Wilson, Womack Army Medical Center

Combining Vaginal Preparation and Azithromycin in Reduction of Post Cesarean Infections: A Randomized Controlled Trial

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Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Fort Bragg, North Carolina, United States, 28310
        • Womack Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Vaginal Preparation

One sponge stick will be inserted into the vagina, where it will stay during the scrubbing of thighs and genitals.

One sponge will be used to scrub the right inner thigh from mid-thigh to right labia majora. This sponge will then be discarded.

A second sponge will be used to scrub the left inner thigh from mid-thigh to left labia majora. This sponge will then be discarded.

A third sponge will be used to scrub the mons pubs, labia majora and minor, perineum and rectum in that order then will be discarded. This will be repeated with a fourth sponge.

The existing sponge stick in the vagina will be rotated in the vagina twice then removed. This will be discarded.

A second sponge stick will be inserted in the vagina, rotated twice then removed. As it is removed from the vagina, the perineum and rectum will be swabbed with the stick in that order then discarded. This will be repeated using a third sponge stick.
Sham Comparator: Standard Infection Procedures
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.
Procedure: Vaginal Preparation

One sponge stick will be inserted into the vagina, where it will stay during the scrubbing of thighs and genitals.

One sponge will be used to scrub the right inner thigh from mid-thigh to right labia majora. This sponge will then be discarded.

A second sponge will be used to scrub the left inner thigh from mid-thigh to left labia majora. This sponge will then be discarded.

A third sponge will be used to scrub the mons pubs, labia majora and minor, perineum and rectum in that order then will be discarded. This will be repeated with a fourth sponge.

The existing sponge stick in the vagina will be rotated in the vagina twice then removed. This will be discarded.

A second sponge stick will be inserted in the vagina, rotated twice then removed. As it is removed from the vagina, the perineum and rectum will be swabbed with the stick in that order then discarded. This will be repeated using a third sponge stick.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection rates
Time Frame: Six weeks postpartum
wound infection
Six weeks postpartum
Infection rates
Time Frame: six weeks postpartum
endometritis
six weeks postpartum

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Womack Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2019

Primary Completion (Actual)

July 30, 2021

Study Completion (Actual)

July 30, 2021

Study Registration Dates

First Submitted

November 8, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHC-A-19-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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