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Clean-CS

CheckList Expansion for Antisepsis and iNfection Control in Cesarean Section – CLEAN-CS: A Cluster-Randomized, Stepped Wedge Interventional Trial to Reduce Postoperative Infections Following Cesarean Delivery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202108717887402
Enrollment
7200
Registered
2021-08-24
Start date
2021-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical infections Pregnancy and Childbirth Surgery Complications following cesarean section

Interventions

None
Clean Cut

Sponsors

Bill and Melinda Gates Foundation
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: As obstetric and gynecologic operations are typically undertaking in separate, dedicated operating theatres, we will focus our prospective observations on patients admitted to these theatres. Any patient undergoing surgery at any time in one of the targeted operating theatres is eligible for inclusion; there will be no exclusion criteria. Enrollment will occur at the time of observation and will include various times (day and night) and days of the week (weekdays and weekends). As the standards being implemented are not in dispute and are considered critical for ensuring antisepsis and sterility, patient informed consent will not be obtained. While our focus will be on cesarean delivery, any obstetric or gynecological operation will be included, with the inclusion of other operations in this populations (such as appendectomy for appendicitis that is found incidentally or misdiagnosed as ovarian torsion, for example). There will be no age range limit.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
Surgical infections following cesarean delivery: Number of patients undergoing cesarean delivery diagnosed with postoperative infection in hospital or up to 30 days post surgery; measured by change pre and post intervention

Secondary

MeasureTime frame
Compliance with infection prevention practices: Number of patients undergoing obstetric and gynecologic surgery receiving each of the six perioperative infection prevention and control practices defined by the Clean Cut program; measured by change pre and post intervention ;Surgical infections following obstetric and gynecologic operations: Number of patients undergoing obstetric and gynecologic operations diagnosed with postoperative infection in hospital or up to 30 days post surgery; measured by change pre and post intervention;Reoperation following obstetric and gynecologic surgery: Number of patients requiring reoperation or return to the operating theatre prior to discharge following obstetric and gynecologic surgery; measured by change pre and post intervention;Length of Stay: Mean and median length of stay, in days, following following obstetric and gynecologic surgery; measured by change pre and post intervention;Postoperative maternal mortality: Number of mothers who die in hospital or up to 30 days following CS; measured by change pre and post intervention;Neonatal mortality: Number of newborn/fetal deaths prior to discharge of mother following cesarean delivery; measured by change pre and post intervention;Atlas/MKA Facility Readiness Toolkit scores: Comparison of facility characteristics including assessments of Commitment and Motivation, Ability to Implement, Internal Culture, Clinical Team Functionality, and Knowledge and Ability to engage in quality improvement programs in surgery as measured by the Atlas/MKA Facility Readiness Toolkit;Postoperative mortality: Number of women who die in hospital or up to 30 days following obstetric and gynecologic surgery; measured by change pre- and post-intervention

Countries

Ethiopia

Contacts

Public ContactKitty Jenkins

Head of Communications

kitty@lifebox.org+440000000

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026