NCT04163679

Brief Summary

asdgf

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

1.9 years

First QC Date

November 8, 2019

Last Update Submit

October 6, 2021

Conditions

InfectionObstetric Labor ComplicationsEndometritisCesarean Delivery Affecting FetusWounds Injuries

Outcome Measures

Primary Outcomes (2)

  • Infection rates

    wound infection

    Six weeks postpartum

  • Infection rates

    endometritis

    six weeks postpartum

Secondary Outcomes (7)

  • Infant Birth Weight

    Four weeks after birth

  • Infant Apgar scores

    Four weeks after birth

  • Infant Length of hospital stay

    Four weeks after birth

  • Numbers of Infants admitted to NICU

    four weeks after birth

  • Number of Infants that develop respiratory distress

    Four weeks after birth

  • +2 more secondary outcomes

Study Arms (2)

Vaginal Preparation

EXPERIMENTAL

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

Standard Infection Procedures

SHAM COMPARATOR

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

Interventions

Vaginal PreparationPROCEDURE

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.

Standard Infection ProceduresVaginal Preparation

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant females admitted to Womack Army Medical Center who deliver full term via unscheduled, non-emergent cesarean section following labor
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • full term pregnancy
  • undergoing labored, non-emergent cesarean section
  • patient in labor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

Related Publications (16)

  • 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;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.

    PMID: 25479008BACKGROUND

  • Conroy K, Koenig AF, Yu YH, Courtney A, Lee HJ, Norwitz ER. Infectious morbidity after cesarean delivery: 10 strategies to reduce risk. Rev Obstet Gynecol. 2012;5(2):69-77.

    PMID: 22866185RESULT

  • Tita AT, Szychowski JM, Boggess K, Saade G, Longo S, Clark E, Esplin S, Cleary K, Wapner R, Letson K, Owens M, Abramovici A, Ambalavanan N, Cutter G, Andrews W; C/SOAP Trial Consortium. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016 Sep 29;375(13):1231-41. doi: 10.1056/NEJMoa1602044.

    PMID: 27682034RESULT

  • Tuuli MG, Liu L, Longman RE, Odibo AO, Macones GA, Cahill AG. Infectious morbidity is higher after second-stage compared with first-stage cesareans. Am J Obstet Gynecol. 2014 Oct;211(4):410.e1-6. doi: 10.1016/j.ajog.2014.03.040. Epub 2014 Mar 18.

    PMID: 24657794RESULT

  • Kawakita T, Landy HJ. Surgical site infections after cesarean delivery: epidemiology, prevention and treatment. Matern Health Neonatol Perinatol. 2017 Jul 5;3:12. doi: 10.1186/s40748-017-0051-3. eCollection 2017.

    PMID: 28690864RESULT

  • Tita AT, Hauth JC, Grimes A, Owen J, Stamm AM, Andrews WW. Decreasing incidence of postcesarean endometritis with extended-spectrum antibiotic prophylaxis. Obstet Gynecol. 2008 Jan;111(1):51-6. doi: 10.1097/01.AOG.0000295868.43851.39.

    PMID: 18165392RESULT

  • Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;2014(10):CD007482. doi: 10.1002/14651858.CD007482.pub3.

    PMID: 25350672RESULT

  • Caissutti C, Saccone G, Zullo F, Quist-Nelson J, Felder L, Ciardulli A, Berghella V. Vaginal Cleansing Before Cesarean Delivery: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Sep;130(3):527-538. doi: 10.1097/AOG.0000000000002167.

    PMID: 28796683RESULT

  • Skeith AE, Niu B, Valent AM, Tuuli MG, Caughey AB. Adding Azithromycin to Cephalosporin for Cesarean Delivery Infection Prophylaxis: A Cost-Effectiveness Analysis. Obstet Gynecol. 2017 Dec;130(6):1279-1284. doi: 10.1097/AOG.0000000000002333.

    PMID: 29112658RESULT

  • American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. 2013 Sep;122(3):718-20. doi: 10.1097/01.AOG.0000433982.36184.95.

    PMID: 23963423RESULT

  • Reid VC, Hartmann KE, MCMahon M, Fry EP. Vaginal preparation with povidone iodine and postcesarean infectious morbidity: a randomized controlled trial. Obstet Gynecol. 2001 Jan;97(1):147-52. doi: 10.1016/s0029-7844(00)01087-5.

    PMID: 11152924RESULT

  • Dalton E, Castillo E. Post partum infections: A review for the non-OBGYN. Obstet Med. 2014 Sep;7(3):98-102. doi: 10.1177/1753495X14522784. Epub 2014 Feb 27.

    PMID: 27512432RESULT

  • Zuarez-Easton S, Zafran N, Garmi G, Salim R. Postcesarean wound infection: prevalence, impact, prevention, and management challenges. Int J Womens Health. 2017 Feb 17;9:81-88. doi: 10.2147/IJWH.S98876. eCollection 2017.

    PMID: 28255256RESULT

  • Haas DM, Morgan S, Contreras K, Enders S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2018 Jul 17;7(7):CD007892. doi: 10.1002/14651858.CD007892.pub6.

    PMID: 30016540RESULT

  • Kawakita T, Iqbal SN, Desale S, Fries M. Decrease in surgical site infection after cesarean delivery by implementing surgical bundle. Am J Obstet Gynecol 2018; 218:S323-S323.

    RESULT

  • Guzman MA, Prien SD, Blann DW. Post-cesarean related infection and vaginal preparation with povidone-iodine revisited. Prim Care Update Ob Gyns 2002; 9:206-209.

    RESULT

MeSH Terms

Conditions

InfectionsObstetric Labor ComplicationsEndometritisWounds and Injuries

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesUterine DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director of Obstetrics and Gynecology Residency Chief of Maternal Fetal Medicine and Obstetrics Chief

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 15, 2019

Study Start

September 18, 2019

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

October 11, 2021

Record last verified: 2021-10

Locations

US(1)