Vaginal Cleansing Before Cesarean Delivery to Reduce Infection

The Washington University

Status: Completed

Conditions: Complications; Cesarean Section

Treatments: Procedure: Vaginal Cleansing; Procedure: Abdominal Cleansing

Study type: Interventional

Funder types: Other

Identifiers

NCT02495753

201505127

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

Full description

Cesarean delivery is the most common surgical procedure performed on women in the US; nearly 1.3 million are performed each year. Postoperative infectious morbidity is the most common complication of cesarean delivery. Post-cesarean infectious morbidity is often the result of indigenous vaginal flora that ascend into the uterus at the time of surgery. Thus, reducing vaginal microbial load may reduce post-cesarean infection. However, results from studies assessing the role of vaginal cleansing prior to cesarean have been mixed.

The investigators will perform a randomized controlled clinical trial to test the hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

Enrollment: 608 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women undergoing cesarean delivery after labor at Barnes-Jewish Hospital.

Exclusion criteria

• Inability to obtain consent
• known or suspected allergy to iodine or shellfish
• women with active herpes simplex virus infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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608 participants in 2 patient groups

Abdominal and Vaginal Cleansing

Experimental group

Description:

In the treatment arm, the vagina will be cleansed prior to usual abdominal cleansing before cesarean section.

Treatment:

Procedure: Vaginal Cleansing

Procedure: Abdominal Cleansing

Abdominal Cleansing Alone

Active Comparator group

Description:

In the control arm, abdominal cleansing will be performed per routine with no vaginal cleansing.

Treatment:

Procedure: Abdominal Cleansing