Vaginal Cleansing at Cesarean Delivery to Reduce Infection: A Randomized, Controlled Trial

NCT ID: NCT00386477

Last Updated: 2010-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-05-31

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.

Detailed Description

Infectious morbidity frequently complicates cesarean delivery. Endometritis can complicate the postoperative course of a cesarean delivery 6-27% of the time. This complication, up to 10 times more frequent than after vaginal delivery, can lead to serious complications. Additionally, cesarean deliveries are frequently complicated by maternal fever and wound complications including seroma, hematoma, infection, and separation. These morbidities can lead to significant delay in a return to normal function. Our study will randomize 1000 women who are about to undergo a cesarean delivery into one of two groups. The control group will receive the standard surgical preparation of the abdomen alone, the current standard pre-cesarean preparation. The other group will also receive a povidone iodine washing/scrub of the vagina before the cesarean delivery. Maternal and surgical variables will be recorded. At one months postpartum, maternal outpatient data will be reviewed and the incidence of postpartum uterine infection, wound separations, and other wound and infectious complications will be determined and compared between the two treatment groups.

Comparison: Women receiving standard surgical abdominal cleansing versus women receiving standard abdominal and preoperative vaginal cleansing before cesarean delivery.

Conditions

Cesarean Section; Endometritis; Surgical Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Vag prep

Vagina cleansed prior to performing cesarean

Group Type: EXPERIMENTAL

Vaginal cleansing before cesarean delivery

Intervention Type: PROCEDURE

Cleansing vagina with 1% betadine scrub before cesarean.

Interventions

Vaginal cleansing before cesarean delivery

Cleansing vagina with 1% betadine scrub before cesarean.

Intervention Type: PROCEDURE

Other Intervention Names

1% betadine scrub of vagina with vaginal scrub spongesticks.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Indiana University School of Medicine

Principal Investigators

David M Haas, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Methodist Hospital

Indianapolis, Indiana, United States

University Hospital

Indianapolis, Indiana, United States

Wishard Memorial Hospital

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32335895 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20207251 (View on PubMed)

Other Identifiers

0509-55

Identifier Type: OTHER

Identifier Source: secondary_id

0509-55 (Study #)

Identifier Type: -

Identifier Source: org_study_id