A Perioperative Quality Improvement Program for Cesarean Delivery in Ethiopia
Authors: Mammo Tihitena Negussie , Feyssa Mekdes Daba , Nofal Maia R. , Gebeyehu Natnael , Shiferaw Matiyas Asrat , Tesfaye Assefa , Fikre Tesfaneh , Woldeamanuel Habtamu , Alemu Senait Bitew , Miller Kate , Haile Sara Taye , Weiser Thomas G. ,   Checklist Expansion for Antisepsis and Infection Control in Cesarean Section (CLEAN-CS) Trial Group, Dalelo Tilahun Selfago , Berassa Admasu Alemayehu , G/Mariam Meseret Habte , Wayisso Zerfu Mikias , Tessema Lidet Mekonin , Abie Misganaw Yenealem , Harka- Dechasa Yacob , Kebede Nardose Aynalem , Getie Awlachew Alemaw , Admasu Kalkidan Kassahun , Bekele Bethelhem Zewde , Feyera Motuma Gutu , Temesgen Merga Haile , Rundasa Semun Lebeta , Guta Firaol Milkessa , Adela- Getachew Banteyirga , Weldeyes Hirut Kassa , Ayele Abnet Tesfaye , Gemeda Dawit Hailu , Belay Tirhas Daniel , Mamo Biniam Getnet , Ahmed Shemsedin Ali , Hailemariam Mulualem Addis , Birru Amir Mohammed , Haile Mamush Eshetu , Hailemichael Geremew Negash , Woldearegay Kalkidan Kassaye , Gebrehana Yonas Feleke , Berta Efrata Degu , Sertse Emawayish Tafesse ,  Senkela Lelise Fikre ,  Dari Muhudin Arusi , Dalelo Yimam Yesuf , Ahmed Jemal Arage ,  Ahmed Akmel Nasir , Darebo Detamo Hairu , Dana Wokil Wolde , Milkamo Addissu Ashiko , Begeta Desbel Asfaw , Worku Yigezu Bunaro , Mena Zerihun Zewdie , Legesse Cherinet Tilahun , G/Michael Feleke Habte , Dinber Yitbarek Lorenso , Kefeni Kumera Cheru , Wubante Adane Dires , Kelemework Kidist Asrat , Besir Fikretsion Degemu ,  Dalelo Tibebu Abebe ,  Abera Mohamed Shimelis , Gonbe Mulugeta Worku , Hosiso Solomon Chamiso , Anebo Dagim Tadesse , Sefiw Tsion Kassa , Kasaye Bezawit Mekonnen , Batu Biniyam Jemaneh , Eaba Bikila Fufa , Lemu Eden Abate , Zewde Eyerusalem Kebede , Berhane Kaleb Assefa , Gebeyehu Lela Alemayehu , Gebreegziabher Lidya Araya , Aliyu Nebiyou Elias , Tadesse Meseret Zelalem , Rulisa Stephen , Maswime Salome , Trickey Amber W , Starr Nichole , Forrester, Jared A , Godere Fikremelekot Temesgen , Zewdu Kinfemichael Belayneh , Tesfaye Nebiyou Tigabu , Duressa Ewnetu Mulugeta , Tefera Feron Getachew , Amde Samuel Negash , Begna Garoma Kitesa , Henrich Natalie J , Demissies Hillena Kebede , Kebedew Milena Abreha 
Published: August 2024

Importance

Infections and complications following cesarean delivery are a significant source of maternal mortality in Ethiopia.

Objective

To study the effectiveness of a program to strengthen compliance with perioperative standards and reduce postoperative complications following cesarean delivery.

Design, Setting, and Participants

This stepped-wedge cluster randomized clinical trial included patients undergoing cesarean delivery from August 24, 2021, to January 31, 2023, at 9 hospitals organized into 5 clusters in Ethiopia.

Intervention

Clean Cut, a multimodal surgical quality improvement program that includes process-mapping 6 perioperative standards and creating site-specific, systems-level improvements. The control period was the period before implementation of the intervention.

Main Outcomes and Measures

The primary end point was surgical site infection rate, and secondary end points were maternal mortality and perinatal mortality and a composite outcome of infections and both mortality outcomes. All were assessed at 30 days postoperatively in the intervention and control groups, adjusting for clustering and demographics. Compliance with standards and the relationship between compliance and outcomes were also compared between the 2 arms.

Results

Among 9755 women undergoing cesarean delivery, 5099 deliveries (52.3%) occurred during the control period (2722 emergency cases [53.4%]) and 4656 (47.7%) during the intervention period (2346 emergency cases [50.4%]). Mean (SD) patient age was 27.04 (0.05) years. Thirty-day follow-up was completed for 5153 patients (52.8%). No significant reduction in infection rates was detected after the intervention (OR, 0.84; 95% CI, 0.55-1.27; P = .40). Intraoperative infection prevention standards improved significantly in the intervention arm vs control arm for compliance with at least 5 of the 6 standards (odds ratio [OR], 2.95; 95% CI, 2.40-3.62; P &amp;lt; .001). Regardless of trial arm, high compliance was associated with reduced odds of maternal (OR, 0.32; 95% CI, 0.11-0.93; P = .04) and perinatal (OR, 0.64; 95% CI, 0.47-0.89; P = .008) mortality.

Conclusions and Relevance

In this stepped-wedge cluster randomized clinical trial of patients undergoing cesarean delivery, no significant reductions in surgical site infections were observed. However, compliance with perioperative standards improved following the intervention.

Trial Registration

ClinicalTrials.gov Identifier: NCT04812522; Pan-African Clinical Trials Registry Identifier: PACTR202108717887402