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临床试验/NCT03925155
NCT03925155撤回3 期

A Randomized Trial to Investigate if a Pre-operative Wash With Chlorhexidine vs Povidone-iodine Vaginal Scrub Decreases Infectious Morbidity in Patients Undergoing Cesarean Section After Ruptured Membranes

Montefiore Medical Center0 个研究点开始时间: 2020年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回
主要终点
Postpartum Endometritis

研究概览

简要总结

The objective of this study is to investigate if the rate of infectious morbidity is decreased with the use of chlorhexidine or povidone-iodine vaginal scrub before cesarean section after ruptured membranes.

详细描述

Postpartum endometritis is an infection of the endometrial lining of the uterus clinically diagnosed by fever and uterine fundal tenderness. The most important risk factor for developing endometritis is cesarean section, as it occurs in 11% of cesarean sections after labor and 3% of elective cesarean sections. Other risk factors for endometritis are chorioamnionitis, prolonged labor, prolonged rupture of membranes and vaginal colonization with Group B Streptococcus. Some complications of endometritis include prolonged hospital stay, sepsis, peritonitis and intrapelvic abscess.

Surgical site infections are infections of the incision, organ or space after a procedure and are responsible for 38% of infections in patients undergoing surgery. In obstetric patients, infectious morbidity (wound complication, surgical site infections, endometritis) occurs in 5-10% of cesarean sections, which is 5-fold higher than vaginal deliveries. Additionally, infectious morbidity is thought to be highest in those patients who have cesarean sections after undergoing labor.

Current practices endorsed by ACOG and the CDC to reduce the incidence of infectious morbidity after cesarean section include pre-operative antibiotics and pre-operative skin cleansing with chlorhexidine skin preparation. Chlorhexidine and povidone-iodine are chemical antiseptics that reduces bacteria found on the skin. Additionally, vaginal scrub with 4% chlorhexidine gluconate and 10% povidone-iodine antiseptic solution immediately prior to cesarean section has been embraced into some practices as a means to decrease infectious morbidity. There is abundant literature showing pre-operative vaginal cleansing prior to hysterectomy has been shown to decrease vaginal surgical site antisepsis, however research on its use prior to cesarean section is limited.

This study aims to assess the effectiveness of pre-operative vaginal scrub with 4% chlorhexidine or 10% povidone iodine in reducing infectious morbidity (specifically endometritis and SSI) in patients undergoing cesarean section with previously ruptured membranes. Current standard of care is use of pre-operative vaginal scrub with 10% povidone iodine. Patients will be randomized to one of two groups using pre-operative vaginal scrub for 30 seconds: 4% chlorhexidine or 10% povidone iodine. In addition both groups will receive pre-operative antibiotics with cefazolin and azithromycin, as well as abdominal cleansing with chlorhexidine-alcohol based skin preparation and 0.25% chlorhexidine wipe for 30 seconds, as this is standard of care for women undergoing cesarean section with ruptured membranes. In the event of penicillin allergy, antibiotics are adjusted accordingly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Participants will be blinded to the arm in which they have been assigned. Providers will need to perform vaginal preparation and solutions look different.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Females aged 18-50 years
  • The study will be offered to women at > 24 weeks gestation who are undergoing nonemergent cesarean delivery with ruptured amniotic membranes.
  • All patients undergoing cesarean delivery with ruptured amniotic membranes.

排除标准

  • Emergent cesarean delivery.
  • No ruptured membranes.
  • Allergy to chlorhexidine or povidone-iodine.

研究组 & 干预措施

Chlorhexidine gluconate vaginal scrub

Experimental

Use of chlorhexidine 4% vaginal scrub instead of current standard of care 10% povidone iodine vaginal scrub for cesarean sections

干预措施: EZ scrub vaginal chlorhexidine 4% solution (Drug)

Povidone-iodine vaginal scrub

Active Comparator

Current standard of care 10% povidone iodine vaginal scrub for cesarean sections

干预措施: 10% provodine-iodine vaginal preparation (Drug)

结局指标

主要结局

Postpartum Endometritis

时间窗: 30 day postoperative

determine if there is any change of rates of postpartum endometritis amongst the chlorhexidine vaginal preparation group compared to povidone iodine group

次要结局

  • Rate of wound complications(30 day postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meleen Chuang

Assistant Professor, MD FACOG

Montefiore Medical Center

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