An interventional study of Knowledge Translation of labor management guidelines in Cesarean Section, Dystocia, sponsored by University of Calgary. Completed at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
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
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's enrollment of 88,918 is above the median of 200 across 42 interventional studies indexed under Dystocia.
Browse Dystocia studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Knowledge Translation of labor management guidelines
No intervention at control centers
Rate of Cesarean section
Rate of Cesarean section in primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus
Time frame: at delivery
Rate of perinatal death
Rate of perinatal death for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus
Time frame: at delivery
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
Time frame: at delivery
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
Time frame: at delivery
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
Time frame: at delivery
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
Time frame: at delivery
Rate of blood transfusion
Rate of blood transfusion for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus
Time frame: at delivery
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
Time frame: Within 30 days of delivery
Rate of postpartum hysterectomy
Rate of postpartum hysterectomy for primiparous women in labor, at term (\>= 37 weeks), with a vertex presenting singleton fetus
Time frame: Within 30 days of delivery
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
Time frame: at delivery
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2016 to primary completion in Feb 2020, 40 months.
Of 18 interventional studies with no phase under Dystocia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 40. This study's 40 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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