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

NCT01437228 | Completed Phase 4

• 1 other identifier: gungorduk13
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Endometritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• morbidity

  two days

Study Arms (2)

povidone iodine

OTHER

30-second vaginal scrub with povidone- iodine solution.

Drug: povidone- iodine solution.

CONTROL

PLACEBO COMPARATOR

Drug: placebo

Interventions

povidone- iodine solution. DRUG

%10 Polivinilpirolidon iyot (Polividon- iyot

Also known as: BATTICON Solüsyon. Adeka

povidone iodine

placebo DRUG

NO İNTERVENTİON

Also known as: NO İNTERVENTİON

CONTROL

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (1)

Sisli Etfal Hospital

Istanbul, Sisli, 32377, Turkey (Türkiye)

Location

Related Publications (1)

• 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: 32335895 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mardin Women and Children Hospital

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 20, 2011
• Study Start: October 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 17, 2011

Record last verified: 2011-11

Locations

TU (1)