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| Name | Class |
|---|---|
| Regions Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 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. | ||
| 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. |
| |
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the procedure through 6 weeks following the procedure |
| 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. | During the procedure through 6 weeks following the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the procedure |
| Length of Stay |
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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
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Patients who underwent cesarean section during the second stage of labor and their infants.
Medical staff who participated in the simulation-based educational training on impacted fetal head at cesarean section as part of the QI project.
.
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| Name | Affiliation | Role |
|---|---|---|
| Kamalini X Das, MD | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26868074 | Background | 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. | |
| 23711893 | Background |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quality Improvement Project (Pre-Period) | 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. This arm includes patients who received care pre-period (7/1/2016 to 12/31/2017) who were cared for by providers who had yet to participate in the quality improvement project intervention. |
| FG001 | No Quality Improvement Project (Pre-Period) | The comparison group is Methodist Hospital where the Quality Improvement project did not occur. This arm includes patients who received care pre-period (7/1/2016 to 12/31/2017). This group received care by providers who did not participate in the quality improvement project intervention. |
| FG002 | Quality Improvement Project (Post-Period) | 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. This arm includes patients who received care in the post-period (1/1/2018 to 3/20/2019) who were cared for by providers who had participated in the quality improvement project intervention. |
| FG003 | No Quality Improvement Project (Post-Period) | No Quality Improvement Project: The comparison group is Methodist Hospital where the Quality Improvement project did not occur. This arm includes patients who received care post-period (1/1/2018 to 3/20/2019). This group received care by providers who did not participate in the quality improvement project intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Simulation (7/1/2016 to 12/31/2017) |
| |||||||||||||
| Post-Simulation (1/1/2018 to 6/30/2019) |
|
Number of second stage cesarean section procedures at each study site
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | No Quality Improvement Project (Pre-Period) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | During the procedure through 6 weeks following the procedure |
|
During the procedure through 6 weeks following the procedure
Fetal death was collected as a secondary outcome for analysis. This will be reported as all-cause mortality. Serious and other AE were not defined as primary and secondary study outcomes describe any medical complication that occurred within sample.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kamalini Das | HealthPartners | 651-293-8233 | Kamalini.X.Das@HealthPartners.Com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 30, 2019 | Aug 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
Length of Stay for delivery - Only compared between time periods at Intervention hospital that received quality improvement educational training.
| During the procedure through 6 weeks following the procedure |
| 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. | During the procedure |
| UTI During Maternal Admission | UTI during Maternal Admission (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training. | During the procedure through 6 weeks following the procedure |
| Urethral Injury | Urethral Injury (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training. | During the procedure through 6 weeks following the procedure |
| 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. | During the procedure |
| Fetal Death | Fetal Death (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training. | During the procedure through 6 weeks following the procedure |
| Fetal Hyperbilirubinemia | Fetal Hyperbilirubinemia (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training. | During the procedure through 6 weeks following the procedure |
| 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. | During the procedure |
| Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean Procedures | Response on Likert Scale -
| Surveys distributed directly before, directly after, and 6 months after simulation training. |
| 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. |
| 26301522 | Background | 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. |
| 22541809 | Background | 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. |
| 24290068 | Background | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Maternal BMI | Mean | Standard Deviation | kg/m^2 |
|
| Fetal Weight | Mean | Standard Deviation | grams |
|
| Gestational Age at Time of C-Section | Mean | Standard Deviation | Weeks |
|
| Length of Second Stage | Count of Participants | Participants |
|
| Cesarean Indication | Count of Participants | Participants |
|
| Previous C-Section (% yes) | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| Use of Tocolytics (% yes) | Count of Participants | Participants |
|
| Type of Uterine Incision | Count of Participants | Participants |
|
| Fetal Station | Fetal station indicates how far the baby's head has descended into the pelvis in labor. The farther the baby's head has descended, indicated by higher values, the closer to delivery. Fetal station was assessed by pelvic exam. A value of 0 indicates that the baby's head was at the level of the ischial spine while negative values reflect the distance in centimeters above the ischial spine, and positive values distance below the ischial spine. This measure is purely descriptive and reflect specifics of the 2nd-stage procedure | Count of Participants | Participants |
|
| Delivery Method | Count of Participants | Participants |
|
| Use of Instrumentation | Count of Participants | Participants |
|
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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
|
|
| 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. | Posted | Count of Participants | Participants | During the procedure through 6 weeks following the procedure |
|
|
|
|
| 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. | As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure. | Posted | Mean | Standard Deviation | Minutes | During the procedure |
|
|
|
|
| Secondary | Length of Stay | Length of Stay for delivery - Only compared between time periods at Intervention hospital that received quality improvement educational training. | As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure. | Posted | Mean | Standard Deviation | Hours | During the procedure through 6 weeks following the procedure |
|
|
|
|
| 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. | As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure. | Posted | Mean | Standard Deviation | Minutes | During the procedure |
|
|
|
|
| Secondary | UTI During Maternal Admission | UTI during Maternal Admission (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training. | As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure. | Posted | Count of Participants | Participants | During the procedure through 6 weeks following the procedure |
|
|
|
| Secondary | Urethral Injury | Urethral Injury (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training. | As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure. | Posted | Count of Participants | Participants | During the procedure through 6 weeks following the procedure |
|
|
|
| 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. | As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure. | Posted | Count of Participants | Participants | During the procedure |
|
|
|
|
| Secondary | Fetal Death | Fetal Death (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training. | As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure. | Posted | Count of Participants | Participants | During the procedure through 6 weeks following the procedure |
|
|
|
| Secondary | Fetal Hyperbilirubinemia | Fetal Hyperbilirubinemia (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training. | As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure. | Posted | Count of Participants | Participants | During the procedure through 6 weeks following the procedure |
|
|
|
|
| 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. | As was pre-specified in the Study Protocol, only the participants who received care at the intervention hospital were assessed for this measure. | Posted | Count of Participants | Participants | During the procedure |
|
|
|
|
| Secondary | Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean Procedures | Response on Likert Scale -
| 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. | Posted | Count of Participants | Participants | Surveys distributed directly before, directly after, and 6 months after simulation training. |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | 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. | 0 | 106 | 0 | 106 | 0 | 106 |
| EG002 | 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. | 0 | 73 | 0 | 73 | 0 | 73 |
| EG003 | 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. | 1 | 131 | 0 | 131 | 0 | 131 |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| 2-4 Hours |
|
| 4+ Hours |
|
| Missing |
|
| Fetal |
|
| Missing |
|
| 1 |
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5+ |
|
| Upper Lower Uterine Segment |
|
| Lower Lower Uterine Segment |
|
| Vertical Lower Uterine Segment |
|
| 0 to +1 |
|
| +2 to +3 |
|
| Missing |
|
| Push |
|
| Pull |
|
| Tool (Vacuum or Forceps) |
|
| Missing |
|
Alpha - 0.05
|
| Understand your role during obstetric emergency? |
|
| Understand role of others during emergency? |
|