Trial Outcomes & Findings for An Evaluation of the Team Birth Project (NCT NCT03529214)
NCT ID: NCT03529214
Last Updated: 2025-05-14
Results Overview
At the project midline, percent of clinicians (physicians, midwives, and nurses) who would definitely or probably recommend the Team Birth project tools for use in other labor and delivery units.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5217 participants
Primary outcome timeframe
The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). If clinicians complete more than one survey in the window, we will use the first one.
Results posted on
2025-05-14
Participant Flow
Clinicians: All nurses, midwives, and obstetricians in the participating units were invited to complete surveys using online links/QR codes; Patients: All patients \>= 18 years (except Saint Francis where patients \>= 15 years were included) who did not have a fetal demise or scheduled cesarean delivery were eligible during their postpartum stay
N/A for single group assignment
Participant milestones
| Measure |
Implemented Health Facility
Health facility that has piloted the "Team Birth Project"
Exposed study site: The study sites will pilot the Team Birth Project designed to improve team communication (between providers, as well as providers and patients). The project includes three key implementation steps that involve: preparing local sites for the implementation of the project; training and coaching on the use of the tools; and sustainment through peer coaching and data feedback. A mixed methods approach will be used to assess acceptability and feasibility, including: (1) clinician surveys and interviews, (2) implementation team focus groups, and (3) patient surveys.
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|---|---|
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Overall Study
STARTED
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5217
|
|
Overall Study
Patients
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3924
|
|
Overall Study
Clinicians
|
1293
|
|
Overall Study
COMPLETED
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5217
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of the Team Birth Project
Baseline characteristics by cohort
| Measure |
Implemented Health Facility
n=5217 Participants
Health facility that has piloted the "Team Birth Project"
Exposed study site: The study sites will pilot the Team Birth Project designed to improve team communication (between providers, as well as providers and patients). The project includes three key implementation steps that involve: preparing local sites for the implementation of the project; training and coaching on the use of the tools; and sustainment through peer coaching and data feedback. A mixed methods approach will be used to assess acceptability and feasibility, including: (1) clinician surveys and interviews, (2) implementation team focus groups, and (3) patient surveys.
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|---|---|
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Age, Customized
Age · Under 20 years old
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79 Participants
n=93 Participants
|
|
Age, Customized
Age · 20 - 24 years old
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443 Participants
n=93 Participants
|
|
Age, Customized
Age · 25 - 29 years old
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1105 Participants
n=93 Participants
|
|
Age, Customized
Age · 30 - 34 years old
|
1439 Participants
n=93 Participants
|
|
Age, Customized
Age · 35 - 39 years old
|
707 Participants
n=93 Participants
|
|
Age, Customized
Age · 40 years old or older
|
107 Participants
n=93 Participants
|
|
Age, Customized
Age · Unknown or Not Reported
|
1337 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
3924 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
0 Participants
n=93 Participants
|
|
Sex/Gender, Customized
Gender · Unknown or Not Reported
|
1293 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
325 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3599 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1293 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
568 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
167 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
2563 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
539 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1370 Participants
n=93 Participants
|
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Region of Enrollment
United States
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5217 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). If clinicians complete more than one survey in the window, we will use the first one.Population: Eligible clinicians (physicians, midwives, and nurses) who responded to a survey during the outcome measure time frame
At the project midline, percent of clinicians (physicians, midwives, and nurses) who would definitely or probably recommend the Team Birth project tools for use in other labor and delivery units.
Outcome measures
| Measure |
Implemented Health Facility
n=375 Participants
Health facility that has piloted the "Team Birth Project"
Exposed study site: The study sites will pilot the Team Birth Project designed to improve team communication (between providers, as well as providers and patients). The project includes three key implementation steps that involve: preparing local sites for the implementation of the project; training and coaching on the use of the tools; and sustainment through peer coaching and data feedback. A mixed methods approach will be used to assess acceptability and feasibility, including: (1) clinician surveys and interviews, (2) implementation team focus groups, and (3) patient surveys.
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|---|---|
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Percent of Clinicians Recommending TeamBirth Project
Definitely
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254 Participants
|
|
Percent of Clinicians Recommending TeamBirth Project
Probably
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83 Participants
|
|
Percent of Clinicians Recommending TeamBirth Project
Maybe
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25 Participants
|
|
Percent of Clinicians Recommending TeamBirth Project
Probably Not
|
13 Participants
|
|
Percent of Clinicians Recommending TeamBirth Project
Definitely Not
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0 Participants
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PRIMARY outcome
Timeframe: The window begins on the 180th day to the 270th day from the start date at each site (180 days to 270 days). Patients were only offered the survey once within the window.Population: Eligible patients who responded to a survey and wanted to make collaborative decisions with clinicians during the outcome measure time frame
At the project midline, percent of patients who definitely or somewhat had the role they wanted in making decisions about their labor, among patients who wanted to make collaborative decisions with clinicians.
Outcome measures
| Measure |
Implemented Health Facility
n=805 Participants
Health facility that has piloted the "Team Birth Project"
Exposed study site: The study sites will pilot the Team Birth Project designed to improve team communication (between providers, as well as providers and patients). The project includes three key implementation steps that involve: preparing local sites for the implementation of the project; training and coaching on the use of the tools; and sustainment through peer coaching and data feedback. A mixed methods approach will be used to assess acceptability and feasibility, including: (1) clinician surveys and interviews, (2) implementation team focus groups, and (3) patient surveys.
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|---|---|
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Percent of Patients With the Role They Wanted in Decision-Making
Yes, definitely
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726 Participants
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Percent of Patients With the Role They Wanted in Decision-Making
Yes, somewhat
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68 Participants
|
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Percent of Patients With the Role They Wanted in Decision-Making
No
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5 Participants
|
|
Percent of Patients With the Role They Wanted in Decision-Making
Don't know / no opinion
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4 Participants
|
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Percent of Patients With the Role They Wanted in Decision-Making
Prefer not to answer
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2 Participants
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Adverse Events
General Maternal Population (Facility Level)
Serious events: 328 serious events
Other events: 662 other events
Deaths: 0 deaths
General Neonate Population (Facility Level)
Serious events: 260 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
General Maternal Population (Facility Level)
n=7716 participants at risk；n=14286 participants at risk
Serious AEs and Other AEs were collected at the facility level for all patients admitted (inclusive of those enrolled and not enrolled in the study). As surveys were anonymous, data from the General Maternal Population are reported as it could not be ruled out that enrolled maternal participants were not affected by severe maternal morbidity as a Serious AE and/or postpartum hemorrhage and maternal blood transfusion as an Other AE. Severe maternal morbidity was defined as the composite maternal outcomes measure developed by the Centers for Disease Control and Prevention, which includes "unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health".
|
General Neonate Population (Facility Level)
n=3737 participants at risk；n=11063 participants at risk
Serious AEs and Other AEs were collected at the facility level for all neonates of admitted patients (inclusive of those enrolled and not enrolled in the study). As surveys were anonymous, data for the General Neonate Population is reported as it could not be ruled out that neonates of enrolled maternal patient participants were not affected by severe or overall unexpected newborn complications as a Serious AE or Other AE, respectively. Unexpected newborn complications was defined as the composite neonatal outcomes measure developed by the California Maternal Quality Care Collaborative and adopted by The Joint Commission, which includes "unexpected newborn complications among full term newborns with no preexisting conditions".
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|---|---|---|
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Pregnancy, puerperium and perinatal conditions
Severe Maternal Morbidity
|
2.3%
328/14286 • Number of events 328 • Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
|
—
0/0 • Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
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|
General disorders
Severe Unexpected Newborn Complication Rate
|
—
0/0 • Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
|
2.4%
260/11063 • Number of events 260 • Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
|
Other adverse events
| Measure |
General Maternal Population (Facility Level)
n=7716 participants at risk；n=14286 participants at risk
Serious AEs and Other AEs were collected at the facility level for all patients admitted (inclusive of those enrolled and not enrolled in the study). As surveys were anonymous, data from the General Maternal Population are reported as it could not be ruled out that enrolled maternal participants were not affected by severe maternal morbidity as a Serious AE and/or postpartum hemorrhage and maternal blood transfusion as an Other AE. Severe maternal morbidity was defined as the composite maternal outcomes measure developed by the Centers for Disease Control and Prevention, which includes "unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health".
|
General Neonate Population (Facility Level)
n=3737 participants at risk；n=11063 participants at risk
Serious AEs and Other AEs were collected at the facility level for all neonates of admitted patients (inclusive of those enrolled and not enrolled in the study). As surveys were anonymous, data for the General Neonate Population is reported as it could not be ruled out that neonates of enrolled maternal patient participants were not affected by severe or overall unexpected newborn complications as a Serious AE or Other AE, respectively. Unexpected newborn complications was defined as the composite neonatal outcomes measure developed by the California Maternal Quality Care Collaborative and adopted by The Joint Commission, which includes "unexpected newborn complications among full term newborns with no preexisting conditions".
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|---|---|---|
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Pregnancy, puerperium and perinatal conditions
Post Partpartum Hemorrhage
|
7.4%
569/7716 • Number of events 569 • Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
|
—
0/0 • Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
|
|
Pregnancy, puerperium and perinatal conditions
Maternal Blood Transfusion
|
1.2%
93/7716 • Number of events 93 • Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
|
—
0/0 • Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
|
|
General disorders
Overall Unexpected Newborn Complication Rate
|
—
0/0 • Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
|
1.3%
50/3737 • Number of events 50 • Up to 18 months at the facility level
Clinician, maternal (at time of survey), and neonate (at time of survey) participants were not monitored/assessed for deaths or AEs. As surveys for maternal participants were anonymous, deaths and AEs could not be ruled out for either maternal or neonate participants. Therefore, Severe Maternal Morbidity, Severe Unexpected Newborn Complications, and Other Adverse Events were monitored/assessed for the general maternal and neonate populations and are reported at the facility level.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place