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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Endometritis
• Intervention / Treatment: Drug: povidone- iodine solution.; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 668
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Sisli
    • İstanbul, Sisli, Turkey, 32377
      • Sisli Etfal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: povidone iodine; 30-second vaginal scrub with povidone- iodine solution.	Drug: povidone- iodine solution.; %10 Polivinilpirolidon iyot (Polividon- iyot; Other Names: BATTICON Solüsyon. Adeka
PLACEBO_COMPARATOR: CONTROL	Drug: placebo; NO İNTERVENTİON; Other Names: NO İNTERVENTİON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	two days

Collaborators and Investigators

• Sponsor: Erzincan Military Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): March 1, 2011
• Study Completion (ACTUAL): April 1, 2011

Study Registration Dates

• First Submitted: September 6, 2011
• First Submitted That Met QC Criteria: September 19, 2011
• First Posted (ESTIMATE): September 20, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 17, 2011
• Last Update Submitted That Met QC Criteria: November 16, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Adnexal Diseases; Pelvic Inflammatory Disease; Endometritis; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: gungorduk13