Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

Sponsor

Womack Army Medical Center (U.S. Fed)

Overall Status

Terminated

CT.gov ID

NCT04163679

Collaborator

(none)

Enrollment

Location

Arms

22.4

Actual Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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Condition or Disease	Intervention/Treatment	Phase
Infection Obstetric Labor Complications Endometritis Cesarean Delivery Affecting Fetus Wounds Injuries	Procedure: Vaginal Preparation	N/A

Detailed Description

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Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 18, 2019

Actual Primary Completion Date :

Jul 30, 2021

Actual Study Completion Date :

Jul 30, 2021

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Infection rates [Six weeks postpartum]
wound infection
Infection rates [six weeks postpartum]
endometritis

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Womack Army Medical Center	Fort Bragg	North Carolina	United States	28310

Sponsors and Collaborators

Womack Army Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;(12):CD009516. doi: 10.1002/14651858.CD009516.pub2. Review.

Responsible Party:

Karen L Wilson, Program Director of Obstetrics and Gynecology Residency Chief of Maternal Fetal Medicine and Obstetrics Chief, Womack Army Medical Center

ClinicalTrials.gov Identifier:

NCT04163679

Other Study ID Numbers: