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Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

NCT04163679 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-10-11

No results posted yet for this study

Summary

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Conditions

  • Infection
  • Obstetric Labor Complications
  • Endometritis
  • Cesarean Delivery Affecting Fetus
  • Wounds Injuries

Interventions

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.

Sponsors & Collaborators

  • Womack Army Medical Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2021-07-30
Completion
2021-07-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163679 on ClinicalTrials.gov