We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03387189
Recruitment Status : Not yet recruiting
First Posted : January 1, 2018
Last Update Posted : January 1, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obstetric Labor Complications Cesarean Section 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 Design

Study Type : Observational
Estimated Enrollment : 760 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morbidity of Second Stage Cesarean Sections Before and After Provider Completion of Simulation Education at Regions Hospital
Anticipated Study Start Date : December 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Quality Improvement Project
Quality Improvement Project: Regions Hospital
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
No Quality Improvement Project: The comparison group is Methodist Hospital, where the Quality Improvement project is not occurring.


Outcome Measures

Primary Outcome Measures :
  1. Change in composite variable of maternal morbidity of second stage cesarean section during the time periods before and after simulation-based training [ Time Frame: July 2014 to June 2019 ]

    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."


  2. Change in composite variable of infant morbidity of second stage cesarean section during the time periods before and after simulation-based training [ Time Frame: July 2014 to June 2019 ]

    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."



Secondary Outcome Measures :
  1. Provider confidence with delivery of the impacted fetal head before and after participating in simulation education [ Time Frame: Pre-simulation, immediately post-simulation, and 6-months post simulation. ]
    Medical staff confidence regarding second stage cesarean sections will be assessed with pre and post-simulation surveys.

  2. Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Operative Time [ Time Frame: July 2014 to June 2019 ]
    Operative Time (minutes)

  3. Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Length of Stay [ Time Frame: July 2014 to June 2019 ]
    Length of Stay (days)

  4. 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 Frame: July 2014 to June 2019 ]
    Time from Skin Incision to Delivery (minutes)

  5. 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 Frame: July 2014 to June 2019 ]
    Time from Uterine Incision to Delivery (minutes)

  6. Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - UTI during Maternal Admission [ Time Frame: July 2014 to June 2019 ]
    UTI during Maternal Admission (yes/no)

  7. Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Bladder Injury [ Time Frame: July 2014 to June 2019 ]
    Bladder Injury (yes/no)

  8. Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Ureteral Injury [ Time Frame: July 2014 to June 2019 ]
    Ureteral Injury (yes/no)

  9. Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Urethral Injury [ Time Frame: July 2014 to June 2019 ]
    Urethral Injury (yes/no)

  10. Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Maternal Discharge Hemoglobin [ Time Frame: July 2014 to June 2019 ]
    Maternal Discharge Hemoglobin (g/dl)

  11. Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - APGAR score at 1 minute [ Time Frame: July 2014 to June 2019 ]
    APGAR score at 1 minute (0-10)

  12. Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Fetal Death [ Time Frame: July 2014 to June 2019 ]
    Fetal Death (yes/no)

  13. Change in maternal and perinatal morbidity of additional secondary outcomes during the time periods before and after simulation education - Fetal Hyperbilirubinemia [ Time Frame: July 2014 to June 2019 ]
    Fetal Hyperbilirubinemia (yes/no)

  14. Association of duration of second stage and maternal and perinatal outcomes [ Time Frame: July 2014 to June 2019 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387189


Contacts
Contact: Kamalini X Das, MD 651-293-8233 Kamalini.X.Das@HealthPartners.Com

Locations
United States, Minnesota
Regions Hospital Enrolling by invitation
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
HealthPartners Institute
Regions Hospital Medical Staff Research, Education and Development Fund
Investigators
Principal Investigator: Kamalini X Das, MD HealthPartners Institute
More Information

Publications:
Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03387189     History of Changes
Other Study ID Numbers: RG1700319
First Posted: January 1, 2018    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Obstetric Labor Complications
Pregnancy Complications