NCT00386477

Brief Summary

The objective of the project is to find out whether cleansing the vagina before a cesarean delivery decreases the risk of complications and infections after having the baby. If this is the case, cleansing the vagina before cesarean delivery can help improve outcomes for many women and make their early postpartum recovery much more pleasant, giving a healthier start for the family.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
9 months until next milestone

Results Posted

Study results publicly available

February 8, 2010

Completed
Last Updated

February 8, 2010

Status Verified

December 1, 2010

Enrollment Period

2.7 years

First QC Date

October 9, 2006

Results QC Date

November 11, 2009

Last Update Submit

January 14, 2010

Conditions

Cesarean SectionEndometritisSurgical Wound Infection

Keywords

Povidone iodinepostoperative infectionpresurgical cleansing

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Experienced Composite Endometritis Plus Wound Complications.

    Endometritis was diagnosed clinically as uterine pain and fever requireing antibiotics. Wound complications included wound infection, seroma, hematoma, or separation.

    1 month

Study Arms (1)

Vag prep

EXPERIMENTAL

Vagina cleansed prior to performing cesarean

Procedure: Vaginal cleansing before cesarean delivery

Interventions

Vaginal cleansing before cesarean deliveryPROCEDURE

Cleansing vagina with 1% betadine scrub before cesarean.

Also known as: 1% betadine scrub of vagina with vaginal scrub spongesticks.
Vag prep

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman undergoing cesarean delivery
  • At least 18 years of age

You may not qualify if:

  • Allergy to iodine containing solutions
  • Planned cesarean hysterectomy
  • Prisoner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University Hospital

Indianapolis, Indiana, 46202, United States

Location

Wishard Memorial Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

  • Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.

    PMID: 32335895DERIVED

  • Haas DM, Pazouki F, Smith RR, Fry AM, Podzielinski I, Al-Darei SM, Golichowski AM. Vaginal cleansing before cesarean delivery to reduce postoperative infectious morbidity: a randomized, controlled trial. Am J Obstet Gynecol. 2010 Mar;202(3):310.e1-6. doi: 10.1016/j.ajog.2010.01.005.

    PMID: 20207251DERIVED

MeSH Terms

Conditions

EndometritisSurgical Wound Infection

Condition Hierarchy (Ancestors)

Pelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was stopped before the planned enrollment of 1000 due to difficulty recruiting. Results are of a planned safety analysis at 300 subjects.

Results Point of Contact

Title
David M. Haas, MD, MS
Organization
Indiana University School of Medicine
dahaas@iupui.edu
317-630-7837

Study Officials

  • David M Haas, MD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 9, 2006

First Posted

October 11, 2006

Study Start

September 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

February 8, 2010

Results First Posted

February 8, 2010

Record last verified: 2010-12

Locations

US(3)