The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia

Cesarean Section, Dystocia Clinical Trial

— REDUCED  

Official title:

The REDUCED Trial: REDucing the Utilization of CEsarean Sections for Dystocia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02874443
• Other study ID #: REB16-1576
• Status: Recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2024
• Source: University of Calgary
• Contact: Stephen Wood, MD MSc
• Phone: 403-9441438
• Email: slwood[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Cluster randomized controlled trial of a knowledge translation intervention of new guidelines for the diagnosis of poor progress in labor. The intervention will be randomized to centres (the clusters) in Alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually, with stratification based on facility type and geographic location. Clustering by centre and not individual caregivers (nurses/physicians) is necessary to prevent leakage or crossover of the intervention to controls. As all participating centres will eventually receive the intervention, the biostatistician will generate a randomization into two "waves". The intervention will be introduced sequentially by strata (Calgary, Edmonton, regional centres, rural centres) to the first "wave" hospitals in multi-week run-in periods after which those strata will be revisited for roll-out to the second "wave" hospitals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: March 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Centers in Alberta that provide intrapartum care, have facilities to perform cesarean section and deliver at least 70 primparous women annually

Exclusion Criteria:

Related Conditions & MeSH terms

• Cesarean Section, Dystocia
• Dystocia

Intervention

Other:
• Knowledge Translation of labor management guidelines

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Cesarean section	Rate of Cesarean section in primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	at delivery
Secondary	Rate of perinatal death	Rate of perinatal death for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	at delivery
Secondary	Rate of neonatal asphyxia	Neonatal asphyxia is defined as intrapartum stillbirth or neonatal death from asphyxia (Perinatal Society of Australia and New Zealand coding) or Neonatal Intensive Care Unit admission and at least two of: a. Apgar score of =5 at 10 minutes; b. Mechanical ventilation or chest compressions for resuscitation within 10 minutes; c. Cord pH < 7.00 (venous or arterial), or arterial base excess = 12 at birth. Rate of neonatal asphyxia for deliveries involving primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	at delivery
Secondary	Rate of moderate or severe asphyxia or meets criteria for therapeutic cooling	Rate of moderate or severe asphyxia or meets criteria for therapeutic cooling for deliveries involving primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	at delivery
Secondary	Rate of neonatal sepsis or suspected sepsis	Rate of neonatal sepsis or suspected sepsis for deliveries involving primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	at delivery
Secondary	Rate of post partum hemorrhage	Rate of post partum hemorrhage for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	at delivery
Secondary	Rate of blood transfusion	Rate of blood transfusion for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	at delivery
Secondary	Rate of postpartum uterine artery/pelvic artery embolization	Rate of postpartum uterine artery/pelvic artery embolization for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	Within 30 days of delivery
Secondary	Rate of postpartum hysterectomy	Rate of postpartum hysterectomy for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	Within 30 days of delivery
Secondary	Rate of postpartum maternal intensive care unit (ICU) admission	Rate of postpartum maternal intensive care unit (ICU) admission for primiparous women in labor, at term (>= 37 weeks), with a vertex presenting singleton fetus	at delivery