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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03387189
Enrollment
409
Registered
2018-01-02
Start date
2018-01-01
Completion date
2019-06-30
Last updated
2024-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Obstetric Labor Complications

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.

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.

Interventions

OTHERQuality 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.

Sponsors

Regions Hospital
CollaboratorOTHER
HealthPartners Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL

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:

Design outcomes

Primary

MeasureTime frameDescription
Composite Variable of Maternal Morbidity of Second Stage Cesarean SectionDuring the procedure through 6 weeks following the procedureFor 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.
Composite Variable of Infant Morbidity of Second Stage Cesarean SectionDuring the procedure through 6 weeks following the procedureFor 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

MeasureTime frameDescription
Time From Uterine Incision to DeliveryDuring the procedureTime from Uterine Incision to Delivery measured in minutes - Only compared between time periods at Intervention hospital that received quality improvement educational training.
UTI During Maternal AdmissionDuring the procedure through 6 weeks following the procedureUTI during Maternal Admission (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.
Urethral InjuryDuring the procedure through 6 weeks following the procedureUrethral Injury (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.
APGAR Score at 1 MinuteDuring the procedureAPGAR 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.
Operative TimeDuring the procedureOperative Time measured in minutes defined as skin incision to delivery - Only compared between time periods at Intervention hospital that received quality improvement educational training.
Fetal HyperbilirubinemiaDuring the procedure through 6 weeks following the procedureFetal Hyperbilirubinemia (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.
Head Pushed up From Below Prior to Cesarean SectionDuring the procedureHead pushed up from below (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.
Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresSurveys 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.
Fetal DeathDuring the procedure through 6 weeks following the procedureFetal Death (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.
Length of StayDuring the procedure through 6 weeks following the procedureLength of Stay for delivery - Only compared between time periods at Intervention hospital that received quality improvement educational training.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

Study start date 1/1/2018, the first date in which a patient received care at the intervention hospital after staff received simulation training. The first 205 patients included in this study (7/1/2016-12/31/2017) were identified retrospectively and received care before the intervention. The next 204 patients (1/1/2018-6/30/2019) were included prospectively, post-implementation of the intervention. Only 73 of the 204 were exposed to providers that partook in the simulation.

Participants by arm

ArmCount
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.
99
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.
106
Quality Improvement Project (Post-Period)
Quality Improvement Project: Post-Period (1/1/2018 to 3/20/2019) Patients received care at the intervention hospital in the 18 months after providers participated in the department-wide, simulation-based educational training.
73
No Quality Improvement Project (Post-Period)
No Quality Improvement Project: Post-Period (1/1/2018 to 3/20/2019) Patients received care at the comparison hospital where no quality improvement educational training had occurred.
131
Total409

Baseline characteristics

CharacteristicQuality Improvement Project (Pre-Period)No Quality Improvement Project (Pre-Period)Quality Improvement Project (Post-Period)No Quality Improvement Project (Post-Period)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
99 Participants106 Participants73 Participants131 Participants409 Participants
Cesarean Indication
Fetal
24 Participants22 Participants28 Participants40 Participants114 Participants
Cesarean Indication
Maternal
73 Participants81 Participants44 Participants90 Participants288 Participants
Cesarean Indication
Missing
2 Participants3 Participants1 Participants1 Participants7 Participants
Delivery Method
Pull
2 Participants1 Participants2 Participants1 Participants6 Participants
Delivery Method
Push
20 Participants9 Participants8 Participants13 Participants50 Participants
Delivery Method
Standard
77 Participants96 Participants63 Participants117 Participants353 Participants
Fetal Station
0 to +1
64 Participants57 Participants50 Participants89 Participants260 Participants
Fetal Station
-2 to -1
7 Participants11 Participants6 Participants13 Participants37 Participants
Fetal Station
+2 to +3
27 Participants37 Participants17 Participants29 Participants110 Participants
Fetal Station
Missing
1 Participants1 Participants0 Participants0 Participants2 Participants
Fetal Weight3619 grams
STANDARD_DEVIATION 468
3609 grams
STANDARD_DEVIATION 460
3534 grams
STANDARD_DEVIATION 436
3526 grams
STANDARD_DEVIATION 460
3571 grams
STANDARD_DEVIATION 458
Gestational Age at Time of C-Section39.9 Weeks
STANDARD_DEVIATION 1.2
40.3 Weeks
STANDARD_DEVIATION 1
39.8 Weeks
STANDARD_DEVIATION 1.3
40.1 Weeks
STANDARD_DEVIATION 1
40.0 Weeks
STANDARD_DEVIATION 1.1
Length of Second Stage
0-2 hours
20 Participants17 Participants11 Participants20 Participants68 Participants
Length of Second Stage
2-4 Hours
37 Participants32 Participants22 Participants46 Participants137 Participants
Length of Second Stage
4+ Hours
41 Participants57 Participants40 Participants64 Participants202 Participants
Length of Second Stage
Missing
1 Participants0 Participants0 Participants1 Participants2 Participants
Maternal BMI33.5 kg/m^2
STANDARD_DEVIATION 5.9
33.5 kg/m^2
STANDARD_DEVIATION 6.6
31.5 kg/m^2
STANDARD_DEVIATION 6.7
32.7 kg/m^2
STANDARD_DEVIATION 6.1
32.9 kg/m^2
STANDARD_DEVIATION 6.3
Parity
0
72 Participants87 Participants54 Participants105 Participants318 Participants
Parity
1
15 Participants14 Participants12 Participants20 Participants61 Participants
Parity
2
9 Participants5 Participants0 Participants5 Participants19 Participants
Parity
3
2 Participants0 Participants3 Participants1 Participants6 Participants
Parity
4
0 Participants0 Participants3 Participants0 Participants3 Participants
Parity
5+
1 Participants0 Participants1 Participants0 Participants2 Participants
Previous C-Section (% yes)17 Participants10 Participants7 Participants21 Participants55 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
99 Participants106 Participants73 Participants131 Participants409 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants
Type of Uterine Incision
Classical
1 Participants0 Participants0 Participants13 Participants14 Participants
Type of Uterine Incision
Lower Lower Uterine Segment
97 Participants106 Participants70 Participants29 Participants302 Participants
Type of Uterine Incision
Upper Lower Uterine Segment
1 Participants0 Participants2 Participants89 Participants92 Participants
Type of Uterine Incision
Vertical Lower Uterine Segment
0 Participants0 Participants1 Participants0 Participants1 Participants
Use of Instrumentation
Missing
0 Participants1 Participants1 Participants0 Participants2 Participants
Use of Instrumentation
None
92 Participants88 Participants68 Participants118 Participants366 Participants
Use of Instrumentation
Tool (Vacuum or Forceps)
7 Participants17 Participants4 Participants13 Participants41 Participants
Use of Tocolytics (% yes)1 Participants0 Participants3 Participants4 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 990 / 1060 / 731 / 131
other
Total, other adverse events
0 / 990 / 1060 / 730 / 131
serious
Total, serious adverse events
0 / 990 / 1060 / 730 / 131

Outcome results

Primary

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.

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quality Improvement Project (Pre-Period)Composite Variable of Infant Morbidity of Second Stage Cesarean Section64 Participants
Quality Improvement Project (Post-Period)Composite Variable of Infant Morbidity of Second Stage Cesarean Section39 Participants
No Quality Improvement Project (Pre-Period)Composite Variable of Infant Morbidity of Second Stage Cesarean Section38 Participants
No Quality Improvement Project (Post-Period)Composite Variable of Infant Morbidity of Second Stage Cesarean Section59 Participants
p-value: 0.46595% CI: [0.53, 4.03]Regression, Logistic
Primary

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.

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quality Improvement Project (Pre-Period)Composite Variable of Maternal Morbidity of Second Stage Cesarean Section64 Participants
Quality Improvement Project (Post-Period)Composite Variable of Maternal Morbidity of Second Stage Cesarean Section39 Participants
No Quality Improvement Project (Pre-Period)Composite Variable of Maternal Morbidity of Second Stage Cesarean Section38 Participants
No Quality Improvement Project (Post-Period)Composite Variable of Maternal Morbidity of Second Stage Cesarean Section59 Participants
p-value: 0.03195% CI: [0.17, 0.91]Regression, Logistic
Secondary

APGAR Score at 1 Minute

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.

Time frame: During the procedure

Population: As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quality Improvement Project (Pre-Period)APGAR Score at 1 Minute17 Participants
Quality Improvement Project (Post-Period)APGAR Score at 1 Minute21 Participants
p-value: 0.195% CI: [-0.01, 0.24]Fisher Exact
Secondary

Fetal Death

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

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

Population: As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quality Improvement Project (Pre-Period)Fetal Death0 Participants
Quality Improvement Project (Post-Period)Fetal Death0 Participants
Secondary

Fetal Hyperbilirubinemia

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

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

Population: As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quality Improvement Project (Pre-Period)Fetal Hyperbilirubinemia27 Participants
Quality Improvement Project (Post-Period)Fetal Hyperbilirubinemia22 Participants
p-value: 0.8195% CI: [-0.12, 17.8]Fisher Exact
Secondary

Head Pushed up From Below Prior to Cesarean Section

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

Time frame: During the procedure

Population: As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quality Improvement Project (Pre-Period)Head Pushed up From Below Prior to Cesarean Section14 Participants
Quality Improvement Project (Post-Period)Head Pushed up From Below Prior to Cesarean Section11 Participants
p-value: 195% CI: [-0.11, 0.13]Fisher Exact
Secondary

Length of Stay

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

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

Population: As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure.

ArmMeasureValue (MEAN)Dispersion
Quality Improvement Project (Pre-Period)Length of Stay76.1 HoursStandard Deviation 23
Quality Improvement Project (Post-Period)Length of Stay75.1 HoursStandard Deviation 19
p-value: 0.7595% CI: [-76, 5.5]t-test, 2 sided
Secondary

Operative Time

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.

Time frame: During the procedure

Population: As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure.

ArmMeasureValue (MEAN)Dispersion
Quality Improvement Project (Pre-Period)Operative Time74.6 MinutesStandard Deviation 33
Quality Improvement Project (Post-Period)Operative Time63.2 MinutesStandard Deviation 22
p-value: 0.0195% CI: [-20.4, -2.5]t-test, 2 sided
Secondary

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

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.

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

Population: The number of participants analyzed reflects a different denominator than other outcomes. This outcome was measured in medical staff at the intervention hospital who participated in the simulation training. We collected survey responses at three timepoints - Directly before participating in the simulation training, directly after participating in the simulation training, and six-months after completing the simulation training. The count of participants reflects the number of survey respondents.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Quality Improvement Project (Pre-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresUnderstand your role during obstetric emergency?57 Participants
Quality Improvement Project (Pre-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresUnderstand role of others during emergency?50 Participants
Quality Improvement Project (Pre-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresPerforming your role during extraction?43 Participants
Quality Improvement Project (Pre-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresAnticipating difficult extraction?56 Participants
Quality Improvement Project (Post-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresAnticipating difficult extraction?90 Participants
Quality Improvement Project (Post-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresPerforming your role during extraction?80 Participants
Quality Improvement Project (Post-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresUnderstand role of others during emergency?100 Participants
Quality Improvement Project (Post-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresUnderstand your role during obstetric emergency?98 Participants
No Quality Improvement Project (Pre-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresUnderstand role of others during emergency?65 Participants
No Quality Improvement Project (Pre-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresAnticipating difficult extraction?62 Participants
No Quality Improvement Project (Pre-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresPerforming your role during extraction?55 Participants
No Quality Improvement Project (Pre-Period)Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean ProceduresUnderstand your role during obstetric emergency?68 Participants
Secondary

Time From Uterine Incision to Delivery

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

Time frame: During the procedure

Population: As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure.

ArmMeasureValue (MEAN)Dispersion
Quality Improvement Project (Pre-Period)Time From Uterine Incision to Delivery1.7 MinutesStandard Deviation 2
Quality Improvement Project (Post-Period)Time From Uterine Incision to Delivery1.2 MinutesStandard Deviation 1
p-value: 0.0295% CI: [-1, -0.1]t-test, 2 sided
Secondary

Urethral Injury

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

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

Population: As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quality Improvement Project (Pre-Period)Urethral Injury0 Participants
Quality Improvement Project (Post-Period)Urethral Injury1 Participants
Secondary

UTI During Maternal Admission

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

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

Population: As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quality Improvement Project (Pre-Period)UTI During Maternal Admission0 Participants
Quality Improvement Project (Post-Period)UTI During Maternal Admission0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026