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

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{2 5 6 10 11}

Research Team

Stephen Wood, MD

Principal Investigator

University of Calgary

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

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

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Obstetric practice guidelines: labor's love lost? [2019]

2. England pubmed.ncbi.nlm.nih.gov

Labour management guidelines for a Tanzanian referral hospital: The participatory development process and birth attendants' perceptions. [2022]

3. United States 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. [2021]

4. United States 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]. [2020]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The safe motherhood initiative: The development and implementation of standardized obstetric care bundles in New York. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Association of abnormal first stage of labor duration and maternal and neonatal morbidity. [2021]

9. Pakistan pubmed.ncbi.nlm.nih.gov

Clinical governance in the management of induction of labour. [2007]

10. England 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. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

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