ClinicalTrials.Veeva

Menu

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

HealthPartners Institute logo

HealthPartners Institute

Status

Completed

Conditions

Cesarean Section
Obstetric Labor Complications

Treatments

Other: Quality Improvement Project

Study type

Observational

Funder types

Other

Identifiers

NCT03387189
RG1700319

Details and patient eligibility

About

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.

Full 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.

Enrollment

409 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

409 participants in 4 patient groups

Quality Improvement Project (Pre-Period)
Description:
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)
Description:
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)
Description:
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.
Treatment:
Other: Quality Improvement Project
No Quality Improvement Project (Post-Period)
Description:
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.

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems