N/A N=205

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

Obstetric Labor Complications · Cesarean Section

Bottom Line

View on ClinicalTrials.gov: NCT03387189 ↗

Enrolled (actual)

205

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: Composite Variable of Maternal Morbidity of Second Stage Cesarean Section — 64; 39; 38; 59 Participants — p=0.031

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Quality Improvement Project (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: HealthPartners Institute
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite Variable of Maternal Morbidity of Second Stage Cesarean Section	64; 39; 38; 59	0.031 sig
PRIMARY Composite Variable of Infant Morbidity of Second Stage Cesarean Section	64; 39; 38; 59	0.465
SECONDARY Operative Time	74.6; 63.2	0.01 sig
SECONDARY Length of Stay	76.1; 75.1	0.75
SECONDARY Time From Uterine Incision to Delivery	1.7; 1.2	0.02 sig
SECONDARY UTI During Maternal Admission	0; 0	—
SECONDARY Urethral Injury	0; 1	—
SECONDARY APGAR Score at 1 Minute	17; 21	0.10
SECONDARY Fetal Death	0; 0	—
SECONDARY Fetal Hyperbilirubinemia	27; 22	0.81
SECONDARY Head Pushed up From Below Prior to Cesarean Section	14; 11	1.0
SECONDARY Provider and Nurse Confidence Associated With Participation in Quality Improvement Training for Second Stage Cesarean Procedures	56; 90; 62; 43; 80; 55	—

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.

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03387189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.