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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03387189
• Other study ID #: RG1700319
• Status: Enrolling by invitation
• Start date: March 19, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2019
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 760
• Est. completion date: April 30, 2020
• Est. primary completion date: October 22, 2019
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Obstetric Labor Complications

Intervention

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.

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Regions Hospital Medical Staff Research, Education and Development Fund

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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