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

NCT ID: NCT03387189

Last Updated: 2024-11-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

409 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstetric Labor Complications Cesarean Section

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 interventions assigned to this group

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.

No interventions assigned to this group

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.

Quality Improvement Project

Intervention Type 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.

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.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Regions Hospital

OTHER

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kamalini X Das, MD

Role: PRINCIPAL_INVESTIGATOR

HealthPartners Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26868074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23711893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26301522 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22541809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24290068 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RG1700319

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Family-Centered Cesarean Delivery
NCT02690077 COMPLETED NA