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Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?

Primary Purpose

Postpartum Endometritis

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
povidone- iodine solution.
placebo
Sponsored by
Erzincan Military Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Endometritis

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women older than 38 weeks estimated gestational age and required cesarean section.

Exclusion Criteria:

  • Highly emergent cesarean
  • Allergy to povidone iodine
  • Chorioamnionitis on admission
  • Fever on admission

Sites / Locations

  • Sisli Etfal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Placebo Comparator

Arm Label

povidone iodine

CONTROL

Arm Description

30-second vaginal scrub with povidone- iodine solution.

Outcomes

Primary Outcome Measures

rate of postpartum endometritis
Endometritis was defined here as body temperature greater than 38.5C with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination

Secondary Outcome Measures

morbidity
Infectious morbidity was documented using established clinical criteria. Febrile morbidity was defined as a persistent fever of at least 38C for at least 24 hours after surgery and not associated with lower abdominal or pelvic tenderness and no signs of infection elsewhere.

Full Information

First Posted
September 6, 2011
Last Updated
November 16, 2011
Sponsor
Erzincan Military Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01437228
Brief Title
Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erzincan Military Hospital

4. Oversight

5. Study Description

Brief Summary
Cesarean delivery rates are increasing in Turkey and a major component of this increase is cesarean on demand. Although data on the rate of cesarean delivery in Turkey is limited, a national study reported a rate of 23.8%. Infectious morbidity, consisting primarily of endomyometritis and wound infection, remains a leading cause of postoperative complications. Estimates of postcesarean infection rates range from 7% to 20%, depending on demographic and obstetric variables. Infection following cesarean delivery results in not only increased hospital stay but also increases the cost of care. Strategies to minimize postoperative infectious and other morbidities have included modifications of surgical technique, changing of gloves, methods of placental delivery, cervical dilatation during cesarean delivery, and altering the uterine position during repair of the uterine incision. Despite these interventions, endometritis is still major problem after cesarean delivery. Endometritis appears to result from ascending vaginal flora bacteria, with anaerobes playing an important role. The microbes endogenous to the vagina change throughout the course of pregnancy and parturition. Larsen and Galask noted that anaerobic species located in the vagina increase dramatically by the third postpartum day. In many cases, the surgeon's hand, reaching below the infant's head or presenting part, is in direct contact with the vagina. Vaginal bacterial flora have been cultured from the delivering surgeon's glove in 79% (95% confidence interval [CI] 58%, 100%) of cesareans that follow labor. In these cases, vaginal flora are delivered directly to the uterus, abdominal cavity, and the abdominal incision. Vaginal preparation has been shown to decrease the quantitative load of vaginal microorganisms as well as to remove certain species of bacteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Endometritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
668 (Actual)

8. Arms, Groups, and Interventions

Arm Title
povidone iodine
Arm Type
Other
Arm Description
30-second vaginal scrub with povidone- iodine solution.
Arm Title
CONTROL
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
povidone- iodine solution.
Other Intervention Name(s)
BATTICON Solüsyon. Adeka
Intervention Description
%10 Polivinilpirolidon iyot (Polividon- iyot
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
NO İNTERVENTİON
Intervention Description
NO İNTERVENTİON
Primary Outcome Measure Information:
Title
rate of postpartum endometritis
Description
Endometritis was defined here as body temperature greater than 38.5C with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
morbidity
Description
Infectious morbidity was documented using established clinical criteria. Febrile morbidity was defined as a persistent fever of at least 38C for at least 24 hours after surgery and not associated with lower abdominal or pelvic tenderness and no signs of infection elsewhere.
Time Frame
two days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women older than 38 weeks estimated gestational age and required cesarean section. Exclusion Criteria: Highly emergent cesarean Allergy to povidone iodine Chorioamnionitis on admission Fever on admission
Facility Information:
Facility Name
Sisli Etfal Hospital
City
İstanbul
State/Province
Sisli
ZIP/Postal Code
32377
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
32335895
Citation
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.
Results Reference
derived

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Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?

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