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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstetric Labor Complications; Cesarean Section
• Intervention / Treatment: Other: Quality Improvement Project

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.

• Study Type: Observational
• Enrollment (Actual): 409

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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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Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Quality Improvement Project (Pre-Period); Quality Improvement Project: Pre-Period (7/1/2016 to 12/31/2017) Patients received care at the intervention hospital in the 18 months before providers participated in the department-wide, simulation-based educational training.
No Quality Improvement Project (Pre-Period); No Quality Improvement Project: Pre-Period (7/1/2016 to 12/31/2017) Patients received care at the comparison hospital where no quality improvement educational training had occurred.
Quality Improvement Project (Post-Period); Quality Improvement Project: Post-Period (1/1/2018 to 6/30/2019) Patients received care at the intervention hospital in the 18 months after providers participated in the department-wide, simulation-based educational training.	Other: Quality Improvement Project; 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.
No Quality Improvement Project (Post-Period); No Quality Improvement Project: Post-Period (1/1/2018 to 6/30/2019) Patients received care at the comparison hospital where no quality improvement educational training had occurred.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Variable of Maternal Morbidity of Second Stage Cesarean Section	For each eligible procedure during the study timeframe, data retrospective programmatic and manual chart reviews was used to flag the presence of any of the following events: 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). These individual endpoints were used to compose a composite variable reflecting maternal morbidity associated with each second stage cesarean section procedure (unit of analysis). The primary outcome variable was coded as "1" if any of the above events were recorded (Yes, maternal morbidity/complication occurred) or "0" if none.	During the procedure through 6 weeks following the procedure
Composite Variable of Infant Morbidity of Second Stage Cesarean Section	For each eligible procedure during the study timeframe, data retrospective programmatic and manual chart reviews was used to flag the presence of any of the following events: 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). These individual endpoints were used to compose a composite variable reflecting infant morbidity associated with each second stage cesarean section procedure (unit of analysis). The primary outcome variable was coded as "1" if any of the above events were recorded (Yes, infant morbidity/complication occurred) or "0" if none. **APGAR score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.	During the procedure through 6 weeks following the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	Operative Time measured in minutes defined as skin incision to delivery - Only compared between time periods at Intervention hospital that received quality improvement educational training.	During the procedure
Length of Stay	Length of Stay for delivery - Only compared between time periods at Intervention hospital that received quality improvement educational training.	During the procedure through 6 weeks following the procedure
Time From Uterine Incision to Delivery	Time from Uterine Incision to Delivery measured in minutes - Only compared between time periods at Intervention hospital that received quality improvement educational training.	During the procedure
UTI During Maternal Admission	UTI during Maternal Admission (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.	During the procedure through 6 weeks following the procedure
Urethral Injury	Urethral Injury (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.	During the procedure through 6 weeks following the procedure
APGAR Score at 1 Minute	APGAR score at 1 minute < 7 (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training. **APGAR score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.	During the procedure
Fetal Death	Fetal Death (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.	During the procedure through 6 weeks following the procedure
Fetal Hyperbilirubinemia	Fetal Hyperbilirubinemia (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.	During the procedure through 6 weeks following the procedure
Head Pushed up From Below Prior to Cesarean Section	Head pushed up from below (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.	During the procedure
Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean Procedures	Response on Likert Scale -; Not at all confident; Slightly confident; Moderately confident; Very confident Reported as % who responded they were very or moderately confident on each item - Only assessed in providers at the Intervention hospital that received quality improvement educational training.	Surveys distributed directly before, directly after, and 6 months after simulation training.

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: Regions Hospital Medical Staff Research, Education and Development Fund
• Investigators: Principal Investigator: Kamalini X Das, MD, HealthPartners Institute

Publications and helpful links

General Publications

• 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. Erratum In: Int J Gynaecol Obstet. 2023 Apr;161(1):333. doi: 10.1002/ijgo.14664.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Obstetric Labor Complications
• Other Study ID Numbers: RG1700319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No