Trial Outcomes & Findings for Evaluation of a Quality Improvement Project on Impacted Fetal Head at Cesarean Section (NCT NCT03387189)

Last Updated: 2024-11-21

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

409 participants

Primary outcome timeframe

During the procedure through 6 weeks following the procedure

Results posted on

2024-11-21

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	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.
Pre-Simulation (7/1/2016 to 12/31/2017) STARTED	99	106	0	0
Pre-Simulation (7/1/2016 to 12/31/2017) COMPLETED	99	106	0	0
Pre-Simulation (7/1/2016 to 12/31/2017) NOT COMPLETED	0	0	0	0
Post-Simulation (1/1/2018 to 6/30/2019) STARTED	0	0	73	131
Post-Simulation (1/1/2018 to 6/30/2019) COMPLETED	0	0	73	131
Post-Simulation (1/1/2018 to 6/30/2019) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Quality Improvement Project (Pre-Period) n=99 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.	No Quality Improvement Project (Pre-Period) n=106 Participants 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) n=73 Participants 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.	No Quality Improvement Project (Post-Period) n=131 Participants 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.	Total n=409 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=106 Participants	0 Participants n=73 Participants	0 Participants n=131 Participants	0 Participants n=409 Participants
Age, Categorical Between 18 and 65 years	99 Participants n=99 Participants	106 Participants n=106 Participants	73 Participants n=73 Participants	131 Participants n=131 Participants	409 Participants n=409 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=106 Participants	0 Participants n=73 Participants	0 Participants n=131 Participants	0 Participants n=409 Participants
Sex: Female, Male Female	99 Participants n=99 Participants	106 Participants n=106 Participants	73 Participants n=73 Participants	131 Participants n=131 Participants	409 Participants n=409 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=106 Participants	0 Participants n=73 Participants	0 Participants n=131 Participants	0 Participants n=409 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Maternal BMI	33.5 kg/m^2 STANDARD_DEVIATION 5.9 • n=99 Participants	33.5 kg/m^2 STANDARD_DEVIATION 6.6 • n=106 Participants	31.5 kg/m^2 STANDARD_DEVIATION 6.7 • n=73 Participants	32.7 kg/m^2 STANDARD_DEVIATION 6.1 • n=131 Participants	32.9 kg/m^2 STANDARD_DEVIATION 6.3 • n=409 Participants
Fetal Weight	3619 grams STANDARD_DEVIATION 468 • n=99 Participants	3609 grams STANDARD_DEVIATION 460 • n=106 Participants	3534 grams STANDARD_DEVIATION 436 • n=73 Participants	3526 grams STANDARD_DEVIATION 460 • n=131 Participants	3571 grams STANDARD_DEVIATION 458 • n=409 Participants
Gestational Age at Time of C-Section	39.9 Weeks STANDARD_DEVIATION 1.2 • n=99 Participants	40.3 Weeks STANDARD_DEVIATION 1 • n=106 Participants	39.8 Weeks STANDARD_DEVIATION 1.3 • n=73 Participants	40.1 Weeks STANDARD_DEVIATION 1.0 • n=131 Participants	40.0 Weeks STANDARD_DEVIATION 1.1 • n=409 Participants
Length of Second Stage 0-2 hours	20 Participants n=99 Participants	17 Participants n=106 Participants	11 Participants n=73 Participants	20 Participants n=131 Participants	68 Participants n=409 Participants
Length of Second Stage 2-4 Hours	37 Participants n=99 Participants	32 Participants n=106 Participants	22 Participants n=73 Participants	46 Participants n=131 Participants	137 Participants n=409 Participants
Length of Second Stage 4+ Hours	41 Participants n=99 Participants	57 Participants n=106 Participants	40 Participants n=73 Participants	64 Participants n=131 Participants	202 Participants n=409 Participants
Length of Second Stage Missing	1 Participants n=99 Participants	0 Participants n=106 Participants	0 Participants n=73 Participants	1 Participants n=131 Participants	2 Participants n=409 Participants
Cesarean Indication Maternal	73 Participants n=99 Participants	81 Participants n=106 Participants	44 Participants n=73 Participants	90 Participants n=131 Participants	288 Participants n=409 Participants
Cesarean Indication Fetal	24 Participants n=99 Participants	22 Participants n=106 Participants	28 Participants n=73 Participants	40 Participants n=131 Participants	114 Participants n=409 Participants
Cesarean Indication Missing	2 Participants n=99 Participants	3 Participants n=106 Participants	1 Participants n=73 Participants	1 Participants n=131 Participants	7 Participants n=409 Participants
Previous C-Section (% yes)	17 Participants n=99 Participants	10 Participants n=106 Participants	7 Participants n=73 Participants	21 Participants n=131 Participants	55 Participants n=409 Participants
Parity 0	72 Participants n=99 Participants	87 Participants n=106 Participants	54 Participants n=73 Participants	105 Participants n=131 Participants	318 Participants n=409 Participants
Parity 1	15 Participants n=99 Participants	14 Participants n=106 Participants	12 Participants n=73 Participants	20 Participants n=131 Participants	61 Participants n=409 Participants
Parity 2	9 Participants n=99 Participants	5 Participants n=106 Participants	0 Participants n=73 Participants	5 Participants n=131 Participants	19 Participants n=409 Participants
Parity 3	2 Participants n=99 Participants	0 Participants n=106 Participants	3 Participants n=73 Participants	1 Participants n=131 Participants	6 Participants n=409 Participants
Parity 4	0 Participants n=99 Participants	0 Participants n=106 Participants	3 Participants n=73 Participants	0 Participants n=131 Participants	3 Participants n=409 Participants
Parity 5+	1 Participants n=99 Participants	0 Participants n=106 Participants	1 Participants n=73 Participants	0 Participants n=131 Participants	2 Participants n=409 Participants
Use of Tocolytics (% yes)	1 Participants n=99 Participants	0 Participants n=106 Participants	3 Participants n=73 Participants	4 Participants n=131 Participants	8 Participants n=409 Participants
Type of Uterine Incision Classical	1 Participants n=99 Participants	0 Participants n=106 Participants	0 Participants n=73 Participants	13 Participants n=131 Participants	14 Participants n=409 Participants
Type of Uterine Incision Upper Lower Uterine Segment	1 Participants n=99 Participants	0 Participants n=106 Participants	2 Participants n=73 Participants	89 Participants n=131 Participants	92 Participants n=409 Participants
Type of Uterine Incision Lower Lower Uterine Segment	97 Participants n=99 Participants	106 Participants n=106 Participants	70 Participants n=73 Participants	29 Participants n=131 Participants	302 Participants n=409 Participants
Type of Uterine Incision Vertical Lower Uterine Segment	0 Participants n=99 Participants	0 Participants n=106 Participants	1 Participants n=73 Participants	0 Participants n=131 Participants	1 Participants n=409 Participants
Fetal Station -2 to -1	7 Participants n=99 Participants	11 Participants n=106 Participants	6 Participants n=73 Participants	13 Participants n=131 Participants	37 Participants n=409 Participants
Fetal Station 0 to +1	64 Participants n=99 Participants	57 Participants n=106 Participants	50 Participants n=73 Participants	89 Participants n=131 Participants	260 Participants n=409 Participants
Fetal Station +2 to +3	27 Participants n=99 Participants	37 Participants n=106 Participants	17 Participants n=73 Participants	29 Participants n=131 Participants	110 Participants n=409 Participants
Fetal Station Missing	1 Participants n=99 Participants	1 Participants n=106 Participants	0 Participants n=73 Participants	0 Participants n=131 Participants	2 Participants n=409 Participants
Delivery Method Standard	77 Participants n=99 Participants	96 Participants n=106 Participants	63 Participants n=73 Participants	117 Participants n=131 Participants	353 Participants n=409 Participants
Delivery Method Push	20 Participants n=99 Participants	9 Participants n=106 Participants	8 Participants n=73 Participants	13 Participants n=131 Participants	50 Participants n=409 Participants
Delivery Method Pull	2 Participants n=99 Participants	1 Participants n=106 Participants	2 Participants n=73 Participants	1 Participants n=131 Participants	6 Participants n=409 Participants
Use of Instrumentation None	92 Participants n=99 Participants	88 Participants n=106 Participants	68 Participants n=73 Participants	118 Participants n=131 Participants	366 Participants n=409 Participants
Use of Instrumentation Tool (Vacuum or Forceps)	7 Participants n=99 Participants	17 Participants n=106 Participants	4 Participants n=73 Participants	13 Participants n=131 Participants	41 Participants n=409 Participants
Use of Instrumentation Missing	0 Participants n=99 Participants	1 Participants n=106 Participants	1 Participants n=73 Participants	0 Participants n=131 Participants	2 Participants n=409 Participants

PRIMARY outcome

Timeframe: During the procedure through 6 weeks following the procedure

Outcome measures

Outcome measures
Measure	Quality Improvement Project (Pre-Period) n=99 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.	Quality Improvement Project (Post-Period) n=73 Participants 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 (6-Months-Post) n=106 Participants Providers/Nurse participants who responded to survey six-months post simulation training	No Quality Improvement Project (Post-Period) n=131 Participants 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.
Composite Variable of Maternal Morbidity of Second Stage Cesarean Section	64 Participants	39 Participants	38 Participants	59 Participants

PRIMARY outcome

Timeframe: 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.