Labor Management Guidelines for Difficult Labor
(REDUCED Trial)
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Calgary
Disqualifiers: Non-Alberta centers, Low delivery volume, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This project is a clustered randomized controlled trial of a knowledge translation intervention of new ACOG guidelines for the diagnosis of poor progress in labor. The intent is to reduce the rate of cesarean section (CS) in first time mothers at term (\>= 37 weeks), with a vertex presenting singleton fetus, without increasing maternal or neonatal morbidity. The guidelines were developed from data from the Consortium for Safe Labor. The unit of randomization will be sites in Alberta that deliver
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment Knowledge Translation of labor management guidelines?
The research suggests that implementing clinical practice guidelines can help improve care and reduce healthcare costs, but it also highlights the importance of critically evaluating new guidelines to avoid potential harm. The study on the WHO Labor Care Guide indicates that guidelines can reduce cesarean sections, suggesting that well-implemented guidelines may improve labor management outcomes.12345
Is the implementation of labor management guidelines generally safe for humans?
The implementation of labor management guidelines, such as those by the American College of Obstetricians and Gynecologists, aims to improve care and reduce adverse events, but there is concern that uncritically adopting new guidelines without thorough vetting may lead to patient harm. The Safe Motherhood Initiative in New York has shown that standardized protocols can enhance maternal care outcomes, suggesting that when guidelines are carefully developed and implemented, they can be safe and beneficial.16789
How is the treatment 'Knowledge Translation of labor management guidelines' different from other treatments for difficult labor?
This treatment focuses on implementing and translating existing labor management guidelines into practice, which is unique because it emphasizes adapting guidelines to local contexts and improving healthcare providers' understanding and use of these guidelines, rather than introducing a new drug or medical procedure.2561011
Eligibility Criteria
The REDUCED Trial is for first-time mothers at term (>= 37 weeks) with a baby in head-down position, delivering in Alberta centers that can perform cesarean sections and care during labor. Centers must handle over 70 such births yearly to participate.Inclusion Criteria
Centers in Alberta that provide intrapartum care, have facilities to perform cesarean section, and deliver at least 70 primiparous women annually
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Intervention
Application of a knowledge translation strategy of new clinical practice guidelines on labor management to physicians and nurses
Multi-week run-in periods
Follow-up
Participants are monitored for safety and effectiveness after intervention
30 days
Treatment Details
Interventions
- Knowledge Translation of labor management guidelines (Behavioural Intervention)
Trial OverviewThis trial tests the effectiveness of sharing new guidelines on managing difficult labor among healthcare providers. The goal is to lower cesarean section rates without increasing risks to mother or baby by using data-driven management practices.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention centersExperimental Treatment1 Intervention
Application of a knowledge translation strategy, of new clinical practice guidelines on labor management, to physicians and nurses caring for women in labor.
Intervention centers will receive knowledge translation of labor management guidelines
Group II: Control centersActive Control1 Intervention
No intervention at control centers
Knowledge Translation of labor management guidelines is already approved in Canada, United States for the following indications:
🇨🇦 Approved in Canada as Knowledge Translation of labor management guidelines for:
- Reduction of cesarean sections in first-time mothers at term (≥ 37 weeks) with a vertex presenting singleton fetus
🇺🇸 Approved in United States as Implementation of ACOG guidelines for labor management for:
- Management of labor to prevent unnecessary cesarean sections
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of CalgaryCalgary, Canada
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Who Is Running the Clinical Trial?
University of CalgaryLead Sponsor
References
Obstetric practice guidelines: labor's love lost? [2019]Implementation of clinical practice guidelines may moderate health care costs, improve care, reduce medicolegal liability, and provide a uniformity in care allowing meaningful investigation of treatments and outcomes. However, new guidelines are often uncritically embraced by clinicians, risk management organizations, insurance companies, and the courts as the standard of care. Adoption of incompletely vetted recommendations can lead to patient harm. Recent recommendations made by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine for assessment and management of labor provide an example of well-intended guidelines adopted uncritically. Ideally, but unattainably, each step in a practice guideline would be supported by results of prospective randomized trials. Usually, data from lower on the hierarchy of proof are included, and the personal or institutional preferences of the guideline developers influence the final product. These multiple resources help illuminate critical issues and balance competing perspectives, but can introduce biases that become embedded in our practice. The new labor management guidelines, which were never shown to be superior (or even equivalent) to current standards, have achieved widespread acceptance. Although they provide a formula for reducing the cesarean rate, they do so without concern for their potentially adverse effects on maternal or neonatal outcome. New guidelines should be outcome-based and address how to practice obstetrics to yield the best possible results for mother and baby.
Labour management guidelines for a Tanzanian referral hospital: The participatory development process and birth attendants' perceptions. [2022]While international guidelines for intrapartum care appear to have increased rapidly since 2000, literature suggests that it has only in few instances been matched with reviews of local modifications, use, and impact at the targeted low resource facilities. At a Tanzanian referral hospital, this paper describes the development process of locally achievable, partograph-associated, and peer-reviewed labour management guidelines, and it presents an assessment of professional birth attendants' perceptions.
Why are children still crying? Going beyond "evidence" in guideline development to improve pain care for children: the HELPinKIDS experience. [2021]The failure to translate research evidence into day-to-day clinical practices is identified as a significant reason for suboptimal quality care across the health system, including procedural pain management in children. Clinical practice guidelines (CPGs) have been developed to assist in this process by synthesizing and interpreting research evidence for end users. Numerous CPGs have been developed for procedural pain management in children, yet gaps persist in the adoption of best practices. This article reviews the experience and approach of 1 guideline development group, the Help ELiminate Pain in KIDS Team (HELPinKIDS), in incorporating implementation considerations and knowledge translation (KT) strategies within the process of guideline development for the HELPinKIDS CPG about childhood vaccination pain management to facilitate greater uptake of the CPG. Specific areas that will be addressed include partnerships with stakeholders, rigor of guideline development, issues of implementation, and editorial independence. The work of HELPinKIDS was guided by a KT map, which identified, at a high level, the target audiences, key messages, tools, and strategies that could be used to communicate, disseminate, and implement the CPG into diverse settings. Examples of impact at both the individual and systems levels from HELPinKIDS KT activities are also presented.
[Implementation of the National Childbirth Guidelines in Brazil: barriers and trategiesObstáculos y estrategias para la aplicación de las Directrices Nacionales para el Parto Normal en el Brasil]. [2020]The present report describes the process and results obtained with a knowledge translation project developed in three stages to identify barriers to the National Childbirth Guidelines in Brazil as well strategies for effective implementation. The Improving Programme Implementation through Embedded Research (iPIER) model and the Supporting Policy Relevant Reviews and Trials (SUPPORT) tools provided the methodological framework for the project. In the first stage, the quality of the Guidelines was evaluated and the barriers preventing implementation of the recommendations were identified through review of the global evidence and analysis of contributions obtained in a public consultation process. In the second stage, an evidence synthesis was used as basis for a deliberative dialogue aimed at prioritizing the barriers identified. Finally, a second evidence synthesis was presented in a new deliberative dialogue to discuss six options to address the prioritized barriers: 1) promote the use of multifaceted interventions; 2) promote educational interventions for the adoption of guidelines; 3) perform audits and provide feedback to adjust professional practice; 4) use reminders to mediate the interaction between workers and service users; 5) enable patient-mediated interventions; and 6) engage opinion leaders to promote the use of guidelines. The processes and results associated with each stage were documented and formulated to inform a review and update of the Guidelines and the development of an implementation plan for the recommendations. An effective implementation of the Guidelines is relevant to improve the care provided during labor and childbirth in Brazil.
Impact of WHO Labor Care Guide on reducing cesarean sections at a tertiary center: an open-label randomized controlled trial. [2022]The World Health Organization Labor Care Guide was introduced in December 2020 to implement World Health Organization (WHO) guidelines on intrapartum care for a positive childbirth experience.
Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation. [2021]The World Health Organization's (WHO) Labour Care Guide (LCG) is a "next-generation" partograph based on WHO's latest intrapartum care recommendations. It aims to optimize clinical care provided to women and their experience of care. We evaluated the LCG's usability, feasibility, and acceptability among maternity care practitioners in clinical settings.
The safe motherhood initiative: The development and implementation of standardized obstetric care bundles in New York. [2016]The medical literature demonstrates that inadequate hospital protocols or the lack of consistent protocols for diagnosis, management, consultation, and/or referral can lead to confusion and unnecessary variation in patient care. Incongruities in clinical settings have been repeatedly shown to compromise quality of patient outcomes. Accordingly, the development and adoption of standardized protocols as the best practice for addressing incidence of adverse events remains a top priority in health care quality and safety initiatives. Among the 127 hospital facilities that provide inpatient obstetrical care in New York State, adoption and uptake of standardized care management plans is sporadic at best. In 2001, to target the incidence of severe maternal outcomes and enhance the state of maternal health in New York, the American Congress of Obstetricians and Gynecologists (ACOG) District II and the New York State Department of Health developed the Safe Motherhood Initiative. Today, the Initiative demonstrates that maternal care outcomes are well served through an organized culture of obstetric safety. ACOG District II assists hospitals to optimize their delivery of obstetric care via three toolkits containing standardized protocols for the diagnosis, prevention, and management of the leading causes of maternal mortality and morbidity: hemorrhage, hypertension, and pulmonary embolus.
Association of abnormal first stage of labor duration and maternal and neonatal morbidity. [2021]Contemporary guidelines for labor management do not characterize abnormal labor on the basis of maternal and/or neonatal morbidity.
Clinical governance in the management of induction of labour. [2007]To determine whether dissemination of explicit guidelines, developed in consensus with stakeholders, for the processes of induction of labour (IOL), results in reduction of variability in clinical practice.
Difficulties in the dissemination and implementation of clinical guidelines in government neonatal intensive care units in Brazil: how managers, medical and nursing, position themselves. [2015]Clinical guidelines are tools that systematize scientific evidence and help to achieve proper care. Several difficulties are reported regarding the effective use, such as the shortcomings in the level of knowledge and attitudes by the professionals, the service structure and the preferences appointed by patients. An analysis of these difficulties was the objective of this study in the context of government Neonatal Intensive Care Units (NICU) in Brazil.
Clinical practice guidelines: what are they and how should they be disseminated? [2014]Clinical practice guidelines summarize the available evidence for patient management in a format that is easy for clinicians to use. These guidelines usually use methodologically rigorous principles for retrieving and evaluating the literature and for establishing consensus among work group members, but implementation by clinicians is often incomplete. The reasons why guidelines fail to gain widespread acceptance vary with the topic and clinician group. Successful dissemination of practice guidelines requires an understanding of the barriers to implementation and the use of multiple strategies to address these. This article examines the factors affecting implementation and the approaches to overcoming these obstacles.