Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

Study Overview
=================
Brief Summary
-----------------
asdgf

Detailed Description
-----------------
asdf

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

Conditions
-----------------
Infection, Obstetric Labor Complications, Endometritis, Cesarean Delivery Affecting Fetus, Wounds Injuries

Intervention / Treatment
-----------------
* Procedure: Vaginal Preparation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Preparation<br>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<br>* 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.<br>|
| Sham Comparator: Standard Infection Procedures<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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