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Vaginal Preparation and Azithromycin to Reduce Post Cesarean Infections

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04163679
Enrollment
84
Registered
2019-11-15
Start date
2019-09-18
Completion date
2021-07-30
Last updated
2021-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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Detailed description

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Interventions

PROCEDUREVaginal 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

Womack Army Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Infection ratesSix weeks postpartumwound infection

Secondary

MeasureTime frameDescription
Infant Apgar scoresFour weeks after birthApgar scores
Infant Length of hospital stayFour weeks after birthHospital stay (days)
Numbers of Infants admitted to NICUfour weeks after birthInfant admission to neonatal intensive care unit
Infant Birth WeightFour weeks after birthrecord their birth weight (gm)
Number of Infants that develop sepsisFour weeks after birthInfant acquiring sepsis
Number of infants that dieFour weeks after birthInfant death
Number of Infants that develop respiratory distressFour weeks after birthThe infant acquiring the condition of respiratory distress

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026