An observational study in Obstetric Labor Complications and Cesarean Section, sponsored by HealthPartners Institute. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by HealthPartners Institute · Observational
Among 26 studies in Obstetric Labor Complications with a site in United States — 9 open to participants now, 9 under way, none of them phase 3. Obstetric Labor Complications · United States.
Among the 26 studies in Obstetric Labor Complications with a site in United States, this one is one of 2 that started in 2018, is one of 6 observational ones, and was the 8th registered.
88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.
Browse Obstetric Labor Complications studies →9 of the 26 studies in Obstetric Labor Complications with a site in United States are open now. Recruiting first, the newest first:
Duke University · Sites in United States
Ages 0 days–9 mo
University of Oklahoma · Sites in United States
Ages 15–45 · Women only
Women and Infants Hospital of Rhode Island · Sites in United States
Ages 18+ · Women only · Healthy volunteers
Oregon Health and Science University · Sites in United States
Ages 18–65 · Women only · Healthy volunteers
Washington University School of Medicine · Sites in United States
Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 18 Obstetric Labor Complications studies recruiting now, 7 (39%) set no upper age limit and 9 (50%) stop at 75 or younger; 4 take children under 18; 11 take healthy volunteers.
This study: all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 2 · Phase 3 2 · Phase 4 1
First in 2002; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 409 is above the median of 300 across 25 observational studies indexed under Obstetric Labor Complications.
Median enrollment 95 across the 20 interventional studies, 280 across the 6 observational. Of the 17 that completed or were terminated, 7 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 26 has an industry lead sponsor. The 10 most frequent:
HealthPartners Institute is the lead sponsor of 167 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
HealthPartners Institute has 1 study filed under Obstetric Labor Complications — fewer than ten, so there is no comparison to draw.
2 of the studies in Obstetric Labor Complications with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04303702Washington University School of MedicineThe Role of Oxytocin in the Second Stage of Labor | 2027-06-01 |
| NCT05264779Indiana UniversityThe Periviable GOALS Decision Support Tool | 2027-11 |
Add all 2 to your calendar (.ics) → With an account.
Among the 26 studies in Obstetric Labor Complications with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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 (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 (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.
Other: Quality Improvement Project
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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.
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.
| Milestone | Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Post-Period) |
|---|---|---|---|---|
| Started | 99 | 106 | 0 | 0 |
| Completed | 99 | 106 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Post-Period) |
|---|---|---|---|---|
| Started | 0 | 0 | 73 | 131 |
| Completed | 0 | 0 | 73 | 131 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| Participants | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Post-Period) |
|---|---|---|---|---|
| Composite Variable of Maternal Morbidity of Second Stage Cesarean Section | 64 | 39 | 38 | 59 |
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.
| Participants | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Post-Period) |
|---|---|---|---|---|
| Composite Variable of Infant Morbidity of Second Stage Cesarean Section | 64 | 39 | 38 | 59 |
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.
| Minutes | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) |
|---|---|---|
| Operative Time | 74.6 ± 33 | 63.2 ± 22 |
Length of Stay for delivery - Only compared between time periods at Intervention hospital that received quality improvement educational training.
| Hours | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) |
|---|---|---|
| Length of Stay | 76.1 ± 23 | 75.1 ± 19 |
Time from Uterine Incision to Delivery measured in minutes - Only compared between time periods at Intervention hospital that received quality improvement educational training.
| Minutes | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) |
|---|---|---|
| Time From Uterine Incision to Delivery | 1.7 ± 2 | 1.2 ± 1 |
UTI during Maternal Admission (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.
| Participants | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) |
|---|---|---|
| UTI During Maternal Admission | 0 | 0 |
Urethral Injury (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.
| Participants | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) |
|---|---|---|
| Urethral Injury | 0 | 1 |
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.
| Participants | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) |
|---|---|---|
| APGAR Score at 1 Minute | 17 | 21 |
Fetal Death (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.
| Participants | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) |
|---|---|---|
| Fetal Death | 0 | 0 |
Fetal Hyperbilirubinemia (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.
| Participants | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) |
|---|---|---|
| Fetal Hyperbilirubinemia | 27 | 22 |
Head pushed up from below (% yes) - Only compared between time periods at Intervention hospital that received quality improvement educational training.
| Participants | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) |
|---|---|---|
| Head Pushed up From Below Prior to Cesarean Section | 14 | 11 |
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.
| Participants | Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | Quality Improvement Project (6-Months-Post) |
|---|---|---|---|
| Anticipating difficult extraction? | 56 | 90 | 62 |
| Performing your role during extraction? | 43 | 80 | 55 |
| Understand your role during obstetric emergency? | 57 | 98 | 68 |
| Understand role of others during emergency? | 50 | 100 | 65 |
Collected over During the procedure through 6 weeks following the procedure. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quality Improvement Project (Pre-Period) | 0/99 (0%) | 0/99 (0%) | 0/99 (0%) |
| No Quality Improvement Project (Pre-Period) | 0/106 (0%) | 0/106 (0%) | 0/106 (0%) |
| Quality Improvement Project (Post-Period) | 0/73 (0%) | 0/73 (0%) | 0/73 (0%) |
| No Quality Improvement Project (Post-Period) | 1/131 (0.8%) | 0/131 (0%) | 0/131 (0%) |
Number of second stage cesarean section procedures at each study site
| Age, Categorical(Participants) | Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Post-Period) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 99 | 106 | 73 | 131 | 409 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Post-Period) | Total |
|---|---|---|---|---|---|
| Female | 99 | 106 | 73 | 131 | 409 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Post-Period) | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Maternal BMI(kg/m^2) | Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Post-Period) | Total |
|---|---|---|---|---|---|
| Mean | 33.5 ± 5.9 | 33.5 ± 6.6 | 31.5 ± 6.7 | 32.7 ± 6.1 | 32.9 ± 6.3 |
| Fetal Weight(grams) | Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Post-Period) | Total |
|---|---|---|---|---|---|
| Mean | 3619 ± 468 | 3609 ± 460 | 3534 ± 436 | 3526 ± 460 | 3571 ± 458 |
| Gestational Age at Time of C-Section(Weeks) | Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Post-Period) | Total |
|---|---|---|---|---|---|
| Mean | 39.9 ± 1.2 | 40.3 ± 1 | 39.8 ± 1.3 | 40.1 ± 1.0 | 40.0 ± 1.1 |
| Length of Second Stage(Participants) | Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Post-Period) | Total |
|---|---|---|---|---|---|
| 0-2 hours | 20 | 17 | 11 | 20 | 68 |
| 2-4 Hours | 37 | 32 | 22 | 46 | 137 |
| 4+ Hours | 41 | 57 | 40 | 64 | 202 |
| Missing | 1 | 0 | 0 | 1 | 2 |
| Cesarean Indication(Participants) | Quality Improvement Project (Pre-Period) | No Quality Improvement Project (Pre-Period) | Quality Improvement Project (Post-Period) | No Quality Improvement Project (Post-Period) | Total |
|---|---|---|---|---|---|
| Maternal | 73 | 81 | 44 | 90 | 288 |
| Fetal | 24 | 22 | 28 | 40 | 114 |
| Missing | 2 | 3 | 1 | 1 | 7 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Jun 2019, 17 months.
Results were first posted in Nov 2024, 5 years 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Obstetric Labor Complications →