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Completed

NCT Number: NCT02495753

Vaginal Cleansing Before Cesarean Delivery to Reduce Infection

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.

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Key information

Conditions

Complications; Cesarean Section Adnexal Diseases Endometritis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Pelvic Inflammatory Disease Urogenital Diseases Uterine Diseases Wound Infection

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal Cleansing

Procedure

The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch.

Abdominal Cleansing

Procedure

The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.

Primary outcomes

  1. Composite Postoperative Infectious Morbidity

    Time frame: 30 days postoperatively

    Maternal fever, endometritis, intrabdominal infection or abscess, wound complication within 30 days of delivery or wound infection.

Secondary outcomes

  1. Adverse Reaction to Vaginal Cleansing

    Time frame: 30 days postoperatively

    Hypersensitivity Reaction or more severe allergic reaction

  2. Length of Hospital Stay

    Time frame: 30 days postoperatively

    Days in hospital

  3. Number of readmissions to hospital for infectious morbidity.

    Time frame: 30 days postoperatively

    Number of times patient is readdmitted for any infectious morbidity.

  4. Treatment for neonatal Sepsis

    Time frame: 30 days postoperatively

    Any antibioitics given for neonate with suspected sepsis.

  5. Number of outpatient visits for infectious morbidiy.

    Time frame: 30 days postoperatively.

    Number of outpatient or emergency room visits related to infectious morbidity.

Other outcomes

  1. Prespecified Stratified Analysis for Subgroups

    Time frame: 30 days postoperatively

    Planned secondary analysis will be aimed at obtaining adjusted assessments of treatment effectiveness with interaction tests used to determine if the effectiveness of vaginal cleansing differs across subgroups. Subgroups include BMI categories, rupture status, chorioamnionitis, stage of labor, cervical dilation >6 cm, gestational age, use of monitors, time in labor, duration of rupture, presence of GBS, labor status, and use of ripening agents.

  2. Prespecified Stratified Analysis for Subgroups

    Time frame: 30 days postoperatively

    Planned secondary analysis will be performed in order to obtain adjusted assessment of treatment effectiveness in subgroups stratified based on the following: administration of azithromycin and time of enrolment date in relation to hospital protocol adjustments for Covid19 screening.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Vaginal Cleansing Before Cesarean Delivery to Reduce Infection: A Randomized Trial

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jul 13, 2015
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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