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Completed

NCT Number: NCT03387189

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

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.

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Key information

Conditions

Obstetric Labor Complications Cesarean Section Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Composite Variable of Maternal Morbidity of Second Stage Cesarean Section

    Time frame: During the procedure through 6 weeks following the procedure

    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.

  2. Composite Variable of Infant Morbidity of Second Stage Cesarean Section

    Time frame: During the procedure through 6 weeks following the procedure

    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.

Secondary outcomes

  1. Operative Time

    Time frame: During the procedure

    Operative Time measured in minutes defined as skin incision to delivery - Only compared between time periods at Intervention hospital that received quality improvement educational training.

  2. Length of Stay

    Time frame: During the procedure through 6 weeks following the procedure

    Length of Stay for delivery - Only compared between time periods at Intervention hospital that received quality improvement educational training.

  3. Time From Uterine Incision to Delivery

    Time frame: During the procedure

    Time from Uterine Incision to Delivery measured in minutes - Only compared between time periods at Intervention hospital that received quality improvement educational training.

  4. UTI During Maternal Admission

    Time frame: During the procedure through 6 weeks following the procedure

    UTI during Maternal Admission (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.

  5. Urethral Injury

    Time frame: During the procedure through 6 weeks following the procedure

    Urethral Injury (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.

  6. APGAR Score at 1 Minute

    Time frame: During the procedure

    APGAR score at 1 minute < 7 (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.

    **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.

  7. Fetal Death

    Time frame: During the procedure through 6 weeks following the procedure

    Fetal Death (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.

  8. Fetal Hyperbilirubinemia

    Time frame: During the procedure through 6 weeks following the procedure

    Fetal Hyperbilirubinemia (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.

  9. Head Pushed up From Below Prior to Cesarean Section

    Time frame: During the procedure

    Head pushed up from below (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.

  10. Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean Procedures

    Time frame: Surveys distributed directly before, directly after, and 6 months after simulation training.

    Response on Likert Scale -

    • Not at all confident
    • Slightly confident
    • Moderately confident
    • Very confident Reported as % who responded they were very or moderately confident on each item - Only assessed in providers at the Intervention hospital that received quality improvement educational training.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Regions Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2018
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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