Clinical trial NCT03387189: Evaluation of a Quality Improvement Project on Impacted Fetal Head at Cesarean Section
Official title: Morbidity of Second Stage Cesarean Sections Before and After Provider Completion of Simulation Education at Regions Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstetric Labor Complications
Cesarean Section
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Regions Hospital
First posted: 2018-01-02
Enrollment: 409
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients who underwent cesarean section during the second stage of labor and their infants.
2. Medical staff who participated in the simulation-based educational training on impacted fetal head at cesarean section as part of the QI project.

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Brief summary: This study is an evaluation of a Quality Improvement (QI) project addressing delivery of the impacted fetal head being conducted at Regions Hospital. This study aims to determine the morbidity of second stage cesarean deliveries before and after implementation of simulation protocols that address delivery of the impacted fetal head for Ob/gyn surgeons, nursing staff, and surgical technicians at Regions Hospital.

Detailed description: Cesarean deliveries performed during the second stage of labor can be difficult due to impaction of the fetal head deep in the maternal pelvis and is associated with increased risk of both maternal and perinatal complications. There is little existing data to inform management of deeply impacted fetal heads, therefore these situations can be difficult for surgeons and other healthcare staff when they arise. Team simulations for obstetric emergencies have been shown to assist with provider comfort, improved clarity of thinking, and quicker action during emergency situations resulting in improved outcomes.

This study aims to show that a simulation education project for the entire obstetric team can decrease morbidity of difficult fetal head extraction associated with second stage cesarean deliveries and improve provider and nursing staff confidence regarding anticipation and management of this emergency. The simulation education project is not being conducted for the purpose of research, but is a department-wide educational activity and Quality Improvement project.

Eligibility criteria: Inclusion Criteria:

Patient: The patient study population includes all patients age 18-45 who underwent cesarean section during the second stage of labor (during the time period July 2016-June 2019 at Regions Hospital and Methodist Hospital) and their infants. Second stage is defined as the time between complete cervical dilation and delivery of the infant.

Medical staff: All staff members (staff physicians, residents, nurses, surgical technicians) at Regions Hospital who practice in the Birth Center who underwent required simulation education regarding delivery of impacted fetal heads during second stage cesarean section and completed the surveys as part of the QI project. Note: Medical staff were not enrolled in the research study; rather, staff survey data from the QI project was a data source for the study.

Exclusion Criteria:

Patient: Exclusion criteria include patients who underwent cesarean section in second stage for malpresentations (i.e., breech and noncephalic presentations) and patients who underwent cesarean section prior to 37 weeks gestation.

Medical staff: No exclusion criteria

Primary outcomes:
measure: Composite Variable of Maternal Morbidity of Second Stage Cesarean Section
timeFrame: During the procedure through 6 weeks following the procedure
measure: Composite Variable of Infant Morbidity of Second Stage Cesarean Section
timeFrame: During the procedure through 6 weeks following the procedure
Secondary outcomes:
measure: Operative Time
timeFrame: During the procedure
measure: Length of Stay
timeFrame: During the procedure through 6 weeks following the procedure
measure: Time From Uterine Incision to Delivery
timeFrame: During the procedure
measure: UTI During Maternal Admission
timeFrame: During the procedure through 6 weeks following the procedure
measure: Urethral Injury
timeFrame: During the procedure through 6 weeks following the procedure
measure: APGAR Score at 1 Minute
timeFrame: During the procedure
measure: Fetal Death
timeFrame: During the procedure through 6 weeks following the procedure
measure: Fetal Hyperbilirubinemia
timeFrame: During the procedure through 6 weeks following the procedure
measure: Head Pushed up From Below Prior to Cesarean Section
timeFrame: During the procedure
measure: Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean Procedures
timeFrame: Surveys distributed directly before, directly after, and 6 months after simulation training.
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: Kamalini X Das, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J, Onwude JL. Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilatation. Int J Gynaecol Obstet. 2016 May;133(2):178-82. doi: 10.1016/j.ijgo.2015.09.019. Epub 2016 Jan 15.
citation: Barrier BF, Allison JL, Andelin CO, Drobnis EZ. A simple device prevents hysterotomy extensions during cesarean delivery for failed second stage of labor. Gynecol Obstet Invest. 2013;76(2):90-4. doi: 10.1159/000351567. Epub 2013 May 24.
citation: Jeve YB, Navti OB, Konje JC. Comparison of techniques used to deliver a deeply impacted fetal head at full dilation: a systematic review and meta-analysis. BJOG. 2016 Feb;123(3):337-45. doi: 10.1111/1471-0528.13593. Epub 2015 Aug 24.
citation: Veisi F, Zangeneh M, Malekkhosravi S, Rezavand N. Comparison of "push" and "pull" methods for impacted fetal head extraction during cesarean delivery. Int J Gynaecol Obstet. 2012 Jul;118(1):4-6. doi: 10.1016/j.ijgo.2011.12.027. Epub 2012 Apr 27.
citation: Berhan Y, Berhan A. A meta-analysis of reverse breech extraction to deliver a deeply impacted head during cesarean delivery. Int J Gynaecol Obstet. 2014 Feb;124(2):99-105. doi: 10.1016/j.ijgo.2013.08.014. Epub 2013 Nov 6.