Standardized protocol for labor induction: a type I hybrid effectiveness-implementation trialResearch in context

Summary: Background: Cesarean delivery remains the most common obstetrical procedure with more than 250,000 patients in the US undergoing cesarean following labor induction annually. Here, we evaluated the impact of prospectively implementing a standardized labor induction protocol on cesarean deli...

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Main Authors: Rebecca F. Hamm, Janice Benny, Rinad S. Beidas, Knashawn H. Morales, Sindhu K. Srinivas, Samuel Parry, Lisa D. Levine
Format: Article
Language:English
Published: Elsevier 2025-01-01
Series:The Lancet Regional Health. Americas
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Online Access:http://www.sciencedirect.com/science/article/pii/S2667193X24002837
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author Rebecca F. Hamm
Janice Benny
Rinad S. Beidas
Knashawn H. Morales
Sindhu K. Srinivas
Samuel Parry
Lisa D. Levine
author_facet Rebecca F. Hamm
Janice Benny
Rinad S. Beidas
Knashawn H. Morales
Sindhu K. Srinivas
Samuel Parry
Lisa D. Levine
author_sort Rebecca F. Hamm
collection DOAJ
description Summary: Background: Cesarean delivery remains the most common obstetrical procedure with more than 250,000 patients in the US undergoing cesarean following labor induction annually. Here, we evaluated the impact of prospectively implementing a standardized labor induction protocol on cesarean delivery rates. Methods: This multi-site type I hybrid effectiveness-implementation study compared 2 years before (PRE) and 2 years after (POST) implementation of a standardized labor induction protocol at two hospitals within the University of Pennsylvania Health System (2018–2022). The protocol included multiple components and recommended active management of labor induction, including frequent cervical examinations, amniotomy if cervical exam ≥4 cm, and interventions for labor dystocia. The primary effectiveness outcome was cesarean delivery. Secondary effectiveness outcomes included labor length, chorioamnionitis, and maternal and neonatal morbidity. The primary implementation outcome was fidelity, defined as adherence to ≥75% of the protocol components among 8 individual components that could be evaluated discretely. All data was collected via individual chart review. Findings: 8509 patients were included (PRE: n = 4214, POST: n = 4295). Our population was of median age of 31 years interquartile range (IQR) [26–35], and 44.6% identified as Black, 40.1% as white, 6.9% as Asian, and 8.4% as other or unknown; 7.4% of the population identified as Latinx. There was no significant difference in cesarean delivery rate between the two time periods overall (PRE: 21.6% vs. POST: 21.8%, p = 0.85; adjusted relative risk (aRR) 0.99 95% confidence interval (CI) [0.90–1.09]). There were no significant differences in labor length, chorioamnionitis, or composite neonatal morbidity. Maternal morbidity decreased PRE to POST (PRE: 9.3% vs. POST: 6.5%, p < 0.001; aRR 0.67 95% CI [0.58–0.79]). POST-implementation, inductions with fidelity to ≥75% of protocol components increased (PRE: 52.4% vs. POST: 59.6%, p < 0.001), evidenced by more frequent cervical examinations, earlier dilation at amniotomy, and increased labor dystocia management. Interpretation: Despite increasing standardized induction management, no significant difference in cesarean delivery was found. Funding: NICHD K23HD102523.
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spelling doaj-art-c86d23529bf147c2a4a0c59d9c57d8bd2024-12-11T05:58:11ZengElsevierThe Lancet Regional Health. Americas2667-193X2025-01-0141100956Standardized protocol for labor induction: a type I hybrid effectiveness-implementation trialResearch in contextRebecca F. Hamm0Janice Benny1Rinad S. Beidas2Knashawn H. Morales3Sindhu K. Srinivas4Samuel Parry5Lisa D. Levine6Department of Obstetrics &amp; Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Corresponding author. Department of Obstetrics &amp; Gynecology, Hospital of the University of Pennsylvania, 3400 Spruce Street, 2 Silverstein, Philadelphia, PA, 19104, USA.Department of Obstetrics &amp; Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USADepartment of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USADepartment of Biostatistics, Epidemiology and Informatics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USADepartment of Obstetrics &amp; Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USADepartment of Obstetrics &amp; Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USADepartment of Obstetrics &amp; Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA; Leonard Davis Institute of Health Economics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USASummary: Background: Cesarean delivery remains the most common obstetrical procedure with more than 250,000 patients in the US undergoing cesarean following labor induction annually. Here, we evaluated the impact of prospectively implementing a standardized labor induction protocol on cesarean delivery rates. Methods: This multi-site type I hybrid effectiveness-implementation study compared 2 years before (PRE) and 2 years after (POST) implementation of a standardized labor induction protocol at two hospitals within the University of Pennsylvania Health System (2018–2022). The protocol included multiple components and recommended active management of labor induction, including frequent cervical examinations, amniotomy if cervical exam ≥4 cm, and interventions for labor dystocia. The primary effectiveness outcome was cesarean delivery. Secondary effectiveness outcomes included labor length, chorioamnionitis, and maternal and neonatal morbidity. The primary implementation outcome was fidelity, defined as adherence to ≥75% of the protocol components among 8 individual components that could be evaluated discretely. All data was collected via individual chart review. Findings: 8509 patients were included (PRE: n = 4214, POST: n = 4295). Our population was of median age of 31 years interquartile range (IQR) [26–35], and 44.6% identified as Black, 40.1% as white, 6.9% as Asian, and 8.4% as other or unknown; 7.4% of the population identified as Latinx. There was no significant difference in cesarean delivery rate between the two time periods overall (PRE: 21.6% vs. POST: 21.8%, p = 0.85; adjusted relative risk (aRR) 0.99 95% confidence interval (CI) [0.90–1.09]). There were no significant differences in labor length, chorioamnionitis, or composite neonatal morbidity. Maternal morbidity decreased PRE to POST (PRE: 9.3% vs. POST: 6.5%, p < 0.001; aRR 0.67 95% CI [0.58–0.79]). POST-implementation, inductions with fidelity to ≥75% of protocol components increased (PRE: 52.4% vs. POST: 59.6%, p < 0.001), evidenced by more frequent cervical examinations, earlier dilation at amniotomy, and increased labor dystocia management. Interpretation: Despite increasing standardized induction management, no significant difference in cesarean delivery was found. Funding: NICHD K23HD102523.http://www.sciencedirect.com/science/article/pii/S2667193X24002837Implementation scienceLabor inductionCesarean deliveryMaternal morbidityStandardizationProtocols
spellingShingle Rebecca F. Hamm
Janice Benny
Rinad S. Beidas
Knashawn H. Morales
Sindhu K. Srinivas
Samuel Parry
Lisa D. Levine
Standardized protocol for labor induction: a type I hybrid effectiveness-implementation trialResearch in context
The Lancet Regional Health. Americas
Implementation science
Labor induction
Cesarean delivery
Maternal morbidity
Standardization
Protocols
title Standardized protocol for labor induction: a type I hybrid effectiveness-implementation trialResearch in context
title_full Standardized protocol for labor induction: a type I hybrid effectiveness-implementation trialResearch in context
title_fullStr Standardized protocol for labor induction: a type I hybrid effectiveness-implementation trialResearch in context
title_full_unstemmed Standardized protocol for labor induction: a type I hybrid effectiveness-implementation trialResearch in context
title_short Standardized protocol for labor induction: a type I hybrid effectiveness-implementation trialResearch in context
title_sort standardized protocol for labor induction a type i hybrid effectiveness implementation trialresearch in context
topic Implementation science
Labor induction
Cesarean delivery
Maternal morbidity
Standardization
Protocols
url http://www.sciencedirect.com/science/article/pii/S2667193X24002837
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