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

NCT03387189 | Completed Results

• 1 other identifier: RG1700319
• Study Type: observational
• Target: 409
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Labor Complications; Cesarean Section

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Operative Time

  During the procedure

• Length of Stay

  During the procedure through 6 weeks following the procedure

• Time From Uterine Incision to Delivery

  During the procedure

• UTI During Maternal Admission

  During the procedure through 6 weeks following the procedure

• Urethral Injury

  During the procedure through 6 weeks following the procedure

Study Arms (4)

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

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.

Interventions

Quality Improvement Project OTHER

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.

Quality Improvement Project (Post-Period)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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. .

You may qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead
• Regions Hospital: collaborator

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Related Publications (5)

• 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.

  PMID: 26868074 BACKGROUND

• 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.

  PMID: 23711893 BACKGROUND

• 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.

  PMID: 26301522 BACKGROUND

• 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.

  PMID: 22541809 BACKGROUND

• 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.

  PMID: 24290068 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Kamalini Das
• Organization: HealthPartners

Kamalini.X.Das@HealthPartners.Com

651-293-8233

Study Officials

• Kamalini X Das, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: January 2, 2018
• Study Start: January 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)