Evaluation of a Quality Improvement Project on Impacted Fetal Head at Cesarean Section

Study Overview
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Brief Summary
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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
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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.

Official Title
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Morbidity of Second Stage Cesarean Sections Before and After Provider Completion of Simulation Education at Regions Hospital

Conditions
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Obstetric Labor Complications, Cesarean Section

Intervention / Treatment
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* Other: Quality Improvement Project


Participation Criteria
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Eligibility Criteria
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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 2014-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. 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
Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Quality Improvement Project<br>Quality Improvement Project: Regions Hospital | Other: Quality Improvement Project<br>* Simulation education conducted at Regions Hospital for a Quality Improvement project on delivery of impacted fetal head at cesarean section. This is a department-wide, simulation-based educational training required for all Regions Hospital Birth Center staff physicians, residents, nursing staff, and surgical techs.<br>|
| No Quality Improvement Project<br>No Quality Improvement Project: The comparison group is Methodist Hospital, where the Quality Improvement project is not occurring. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in composite variable of maternal morbidity of second stage cesarean section during the time periods before and after simulation-based training | Data from retrospective programmatic and manual chart review. The composite variable at a specific time point is coded as 1 if one or more of the following are coded as yes: a) extension of uterine incision (yes/no), b) operative blood loss >1000 mL (yes/no), c) requirement of any blood transfusion during cesarean section (yes/no), d) wound infection within 6 weeks of cesarean section (yes/no), e) endometritis within 6 weeks of cesarean section (yes/no). If all elements above are coded are coded as no the maternal morbidity endpoint is coded as 0. | July 2014 to June 2019 | 
| Change in composite variable of infant morbidity of second stage cesarean section during the time periods before and after simulation-based training | Data from retrospective programmatic and manual chart review. The composite variable at a specific time point of infant morbidity is coded as 1 if one or more of the following are coded as yes: a) 5 minute APGAR score <7 (yes/no), b) NICU admission (yes/no), c) umbilical cord arterial pH <7.1 ph units (yes/no), d) fetal injury of cesarean delivery during the second stage of labor (yes/no). If all elements above are coded are coded as no the infant morbidity endpoint at time 1 is coded as 0. | July 2014 to June 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider confidence with delivery of the impacted fetal head before and after participating in simulation education | Medical staff confidence regarding second stage cesarean sections will be assessed with pre and post-simulation surveys. | Pre-simulation, immediately post-simulation, and 6-months post simulation. | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Operative Time | Operative Time (minutes) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Length of Stay | Length of Stay (days) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Time from Skin Incision to Delivery | Time from Skin Incision to Delivery (minutes) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Time from Uterine Incision to Delivery | Time from Uterine Incision to Delivery (minutes) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - UTI during Maternal Admission | UTI during Maternal Admission (yes/no) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Bladder Injury | Bladder Injury (yes/no) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Ureteral Injury | Ureteral Injury (yes/no) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Urethral Injury | Urethral Injury (yes/no) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Maternal Discharge Hemoglobin | Maternal Discharge Hemoglobin (g/dl) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - APGAR score at 1 minute | APGAR score at 1 minute (0-10) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Fetal Death | Fetal Death (yes/no) | July 2014 to June 2019 | 
| Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Fetal Hyperbilirubinemia | Fetal Hyperbilirubinemia (yes/no) | July 2014 to June 2019 | 
| Association of duration of second stage and maternal and perinatal outcomes | Data from retrospective programmatic and manual chart review will be used to assess whether duration of second stage is related to maternal and perinatal complications. | July 2014 to June 2019 |