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