Labor Management Guidelines for Difficult Labor

(REDUCED Trial)

Overseen By Janice Skiffington, MSc

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Non-Alberta centers, Low delivery volume, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new guidelines to help doctors and nurses manage difficult labor for first-time mothers at full term. The goal is to reduce the number of cesarean sections (C-sections) without increasing health issues for mothers or babies. Researchers will compare two groups of hospitals in Alberta: one will implement the new guidelines, while the other will continue with usual practices. This trial is ideal for hospitals in Alberta that deliver many first-time mothers each year. As an unphased trial, it offers a unique opportunity to improve childbirth practices and outcomes.

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 prior data suggests that this knowledge translation intervention is safe for labor management?

Research has shown that using guidelines and checklists during labor can reduce harm by improving communication and making care more consistent. The American College of Obstetricians and Gynecologists (ACOG) supports these practices to enhance the safety and effectiveness of labor. These guidelines assist doctors and nurses in managing labor more effectively, potentially reducing the number of cesarean sections without increasing risks for mothers or babies.

No specific safety concerns are associated with these guidelines. They focus on sharing knowledge and improving how healthcare providers work during labor. As this approach is educational and not a new drug or device, it carries no direct physical risks. The goal is to ensure that labor progresses safely and efficiently, benefiting both mothers and their babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the knowledge translation of labor management guidelines because it aims to directly improve how physicians and nurses manage difficult labor. Unlike many existing treatments that focus solely on medical interventions, this approach emphasizes educating healthcare professionals with the latest guidelines to enhance decision-making and patient care during labor. By integrating these new clinical practice guidelines, the method could lead to more consistent and effective management of labor, potentially reducing complications and improving outcomes for both mothers and babies.

What evidence suggests that the knowledge translation of labor management guidelines is effective for reducing cesarean sections?

This trial will compare the application of new labor management guidelines at intervention centers with standard practices at control centers. Research has shown that clear guidelines during labor can help manage difficult births and reduce unnecessary C-sections. These new guidelines clarify when labor is not progressing and provide specific steps for handling these situations. Studies indicate that following these guidelines can lower the risk of complications by ensuring everyone uses the same, evidence-based plan. This approach helps doctors and nurses make better decisions, leading to safer deliveries for both mothers and babies. By adhering to these guidelines, healthcare teams can improve outcomes without increasing risks. ^{1 2 5 6 7}

Who Is on the Research Team?

Stephen Wood, MD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Knowledge Translation of labor management guidelines

Trial Overview This 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.

How Is the Trial Designed?

Group I: Intervention centers Experimental Treatment 1 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 centers Active Control 1 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

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

A study involving 53 managers from 15 Neonatal Intensive Care Units (NICUs) in Brazil identified key challenges in implementing clinical guidelines, including a lack of healthcare professionals and inadequate infrastructure.

Managers reported that the professionals' knowledge of the guidelines was not a major issue, suggesting that the barriers to effective guideline use are more related to staffing and participation in discussions rather than a lack of understanding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Difficulties in the dissemination and implementation of clinical guidelines in government neonatal intensive care units in Brazil: how managers, medical and nursing, position themselves. Magluta, C., Gomes, MA., Wuillaume, SM.[2015]

In a study of 6823 women, prolonged first stage of labor (above the 90th percentile) was linked to significantly higher risks of maternal morbidity, including complications like fever and the need for transfusions, as well as increased rates of cesarean deliveries.

The same prolonged labor duration was also associated with higher neonatal morbidity, such as respiratory distress and the need for mechanical ventilation, indicating that longer labor can negatively impact both mothers and their babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of abnormal first stage of labor duration and maternal and neonatal morbidity. Blankenship, SA., Raghuraman, N., Delhi, A., et al.[2021]

The HELPinKIDS team developed a clinical practice guideline (CPG) for managing procedural pain in children during vaccinations, focusing on improving the translation of research evidence into everyday clinical practice.

By incorporating knowledge translation strategies and stakeholder partnerships, the HELPinKIDS initiative aims to enhance the adoption of best practices in pain management, addressing gaps in current care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Why are children still crying? Going beyond "evidence" in guideline development to improve pain care for children: the HELPinKIDS experience. Taddio, A., Rogers, JM.[2021]

New clinical practice guidelines, like those from the American College of Obstetricians and Gynecologists, can be adopted without sufficient evidence, potentially leading to patient harm despite their good intentions.

The recent labor management guidelines aim to reduce cesarean rates but have not been proven to be superior to existing standards, raising concerns about their impact on maternal and neonatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetric practice guidelines: labor's love lost? Cohen, WR., Friedman, EA.[2019]

Standardized care management protocols are crucial for improving patient outcomes in obstetrical care, as inconsistent practices can lead to confusion and variations in treatment.

The Safe Motherhood Initiative, developed by ACOG and the New York State Department of Health, has successfully enhanced maternal health outcomes by promoting a culture of obstetric safety and providing hospitals with toolkits for managing critical conditions like hemorrhage and hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safe motherhood initiative: The development and implementation of standardized obstetric care bundles in New York. Burgansky, A., Montalto, D., Siddiqui, NA.[2016]

Clinical practice guidelines are designed to help clinicians manage patient care effectively by summarizing evidence-based practices, but their implementation is often incomplete due to various barriers.

To improve the adoption of these guidelines, it is essential to understand the specific challenges faced by clinicians and to employ multiple strategies to address these obstacles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical practice guidelines: what are they and how should they be disseminated? Graham, B.[2014]

The project identified barriers to implementing the National Childbirth Guidelines in Brazil and proposed strategies to overcome these barriers through a structured three-stage process involving evidence synthesis and deliberative dialogue.

Key strategies for effective implementation include promoting multifaceted and educational interventions, conducting audits with feedback, using reminders for healthcare workers, enabling patient involvement, and engaging opinion leaders to support guideline adoption, all aimed at improving care during labor and childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]. Barreto, JOM., Bortoli, MC., Luquine, CD., et al.[2020]

The WHO Labor Care Guide significantly reduced the primary cesarean delivery rate from 17.8% in the control group to just 1.5% in the study group, indicating its effectiveness in improving labor outcomes.

The use of the Labor Care Guide resulted in a shorter duration of active labor without increasing maternal complications or hospital stay, and it was well-accepted by healthcare providers after an initial learning curve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of WHO Labor Care Guide on reducing cesarean sections at a tertiary center: an open-label randomized controlled trial. Pandey, D., Bharti, R., Dabral, A., et al.[2022]

The development of the PartoMa guidelines, a locally adapted version of international intrapartum care recommendations, involved extensive peer review and resulted in a practical eight-page booklet that simplifies assessments and management for birth attendants at a Tanzanian referral hospital.

A post-implementation survey showed that 93% of professional birth attendants felt the guidelines improved care, with 89% finding them achievable, indicating strong acceptance and potential for enhanced maternal and fetal monitoring in low-resource settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Labour management guidelines for a Tanzanian referral hospital: The participatory development process and birth attendants' perceptions. Maaløe, N., Housseine, N., van Roosmalen, J., et al.[2022]

The Labour Care Guide (LCG) was successfully used by 136 maternity care practitioners in 12 health facilities across six countries, managing the labor of 1,226 low-risk women, with a high satisfaction rate and a median usability score of 67.5%.

The LCG improved monitoring and critical thinking in labor management, promoting woman-centered care, although some design enhancements are recommended for better usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation. Vogel, JP., Comrie-Thomson, L., Pingray, V., et al.[2021]

The dissemination of explicit guidelines for the induction of labor (IOL) significantly reduced variability in clinical practices among healthcare providers, as shown by a study involving 142 women at Aga Khan University.

Key improvements were observed in critical processes, such as timely patient reviews and documentation practices, with nonconformities dropping dramatically (e.g., timely reviews decreased from 72% to 1.4%), indicating that structured guidelines can enhance the quality of obstetric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical governance in the management of induction of labour. Zuberi, NF., Siddiqui, S., Qureshi, RN.[2007]

Citations

1. acog.org acog.org/clinical/clinical-guidance/clinical-practice-guideline/articles/2024/01/first-and-second-stage-labor-management

First and Second Stage Labor Management This guideline provides definitions for labor arrest, along with recommendations for management of dystocia in the first and second stages of labor.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38096556/

First and Second Stage Labor Management: ACOG ... This Clinical Practice Guideline includes definitions of labor and labor arrest, along with recommendations for the management of dystocia in the first and ...

3. ajog.org ajog.org/article/S0002-9378(21)02629-6/fulltext

Are the Labor Management Guidelines evidence based? Its basic premise—namely, that decisions about patient care should be based on the best available objective evidence—is unassailable.

4. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/02/approaches-to-limit-intervention-during-labor-and-birth

Approaches to Limit Intervention During Labor and Birth These data suggest that expectant management is reasonable for women at 4–6 cm dilatation and considered to be in latent labor, as long as maternal and fetal ...

5. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/10/clinical-guidelines-and-standardization-of-practice-to-improve-outcomes

Clinical Guidelines and Standardization of Practice to ... Protocols and checklists have been shown to reduce patient harm through improved standardization and communication.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5710983/

Dysfunctional labor: Case definition & guidelines for data ... Case definitions and guidelines for data collection, analysis, and presentation for dysfunctional labor as an adverse event following immunization.

7. acog.org acog.org/clinical/clinical-guidance/committee-statement/articles/2025/04/quality-improvement-strategies-for-safe-reduction-of-primary-cesarean-birth

Quality-Improvement Strategies for Safe Reduction of ... The American College of Obstetricians and Gynecologists (ACOG) advocates for the use of safety bundles to enhance labor management and support ...