This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for An Evaluation of the Team Birth Project (NCT03529214), a na na study. The primary outcome is Percent of Clinicians Recommending TeamBirth Project.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03529214 |
| Phase | NA |
| Condition | Pregnancy Complications, Cesarean Section Complications, Maternal Complication of Pregnancy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 5217 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Harvard School of Public Health (HSPH) |
| Results posted | Yes |
2. Clinical Question
Population
The primary outcome concerns eligible clinicians—physicians, midwives, and nurses—who responded to a survey during the outcome-measure timeframe. The registry record describes the broader evaluation as a pilot project at hospital sites in the United States. It does not report how many clinicians responded to the survey or the characteristics of those respondents.
Intervention
The intervention is the Team Birth Project, described as a behavioral intervention at an exposed study site. The arm description identifies an implemented health facility as one that piloted the project. The project’s stated purpose includes improving communication and teamwork.
Comparator
No like-for-like control comparison is identified. The registry lists allocation as NA and the model as single group; it also explicitly notes that the arms are not a like-for-like control comparison. The record therefore does not establish a randomized or controlled contrast for interpreting the primary outcome.
Primary question
At project midline, what percentage of eligible responding clinicians would definitely or probably recommend the Team Birth Project tools for use in other labor and delivery units? The record describes this as a feasibility evaluation. Its brief summary also states an intention to increase vaginal delivery rates, but the primary outcome specified in the registry is clinician recommendation, not a delivery-rate comparison.
3. Trial Design
The registry identifies the study as “An Evaluation of the Team Birth Project,” with the official title “A Program Evaluation to Measure the Feasibility of the Team Birth Project.” It is marked completed, with a single-group model and allocation listed as NA. Masking is listed as none, and phase is listed as NA. The registry also cautions that the arms are not a like-for-like control comparison. These characteristics matter because an uncontrolled evaluation does not provide the same basis for attributing an observed change to a project as a randomized comparison.
The intervention is described as an exposed study site and classified as behavioral. The arm description refers to an implemented health facility that piloted the Team Birth Project. The registry gives enrollment as 5217. That figure is the registered enrollment; it should not be read as the number of clinicians who completed the primary-outcome survey, because the record does not report that survey denominator.
The study start date is 2018-05-29, and primary completion is recorded as 2019-09-30. The primary outcome’s survey window is defined relative to the start date at each site: from the 180th day to the 270th day. When a clinician completed more than one survey during that window, the first was to be used. The record does not report the number of sites or the calendar dates of their individual survey windows.
The registry lists 2 outcome measures and 0 analyses. It does not report a statistical analysis plan, a sample-size justification, or a randomized allocation procedure. The project’s stated aims include improving communication and teamwork and increasing vaginal delivery rates, while the specified primary endpoint is clinicians’ recommendation of the project tools.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: N/A for single group assignment
Overall Study
| Stage | Implemented Health Facility |
|---|---|
| STARTED | 5217 |
| Patients | 3924 |
| Clinicians | 1293 |
| COMPLETED | 5217 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Eligible clinicians (physicians, midwives, and nurses) who responded to a survey during the outcome measure time frame
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Participants who consented to participate in patient or clinician surveys for the Team Birth Project; individual demographics were not captured for clinicians so all clinician participants are classified as "Unknown or Not Reported"
| Characteristic | Unit | Implemented Health Facility |
|---|---|---|
| Participants analysed | 5217 | |
| Age, Customized: Age – Under 20 years old | Participants | 79 |
| Age, Customized: Age – 20 - 24 years old | Participants | 443 |
| Age, Customized: Age – 25 - 29 years old | Participants | 1105 |
| Age, Customized: Age – 30 - 34 years old | Participants | 1439 |
| Age, Customized: Age – 35 - 39 years old | Participants | 707 |
| Age, Customized: Age – 40 years old or older | Participants | 107 |
| Age, Customized: Age – Unknown or Not Reported | Participants | 1337 |
| Sex/Gender, Customized: Gender – Female | Participants | 3924 |
| Sex/Gender, Customized: Gender – Male | Participants | 0 |
| Sex/Gender, Customized: Gender – Unknown or Not Reported | Participants | 1293 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 325 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3599 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1293 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 568 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 9 |
| Race (NIH/OMB): Black or African American | Participants | 167 |
| Race (NIH/OMB): White | Participants | 2563 |
| Race (NIH/OMB): More than one race | Participants | 539 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1370 |
| Region of Enrollment: United States | participants | 5217 |
6. Primary Endpoint
The registry lists the primary outcome as Percent of Clinicians Recommending TeamBirth Project, measured over 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..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of clinicians who would definitely or probably recommend the Team Birth Project tools for use in other labor and delivery units. The eligible respondents are physicians, midwives, and nurses who completed a survey during the stated outcome-measure window. The record specifies that if a clinician completed more than one survey in that window, the first response would be used.
This endpoint measures clinicians’ stated acceptance of the tools at project midline. In a feasibility evaluation, such feedback can describe whether intended users view an intervention as suitable for wider use. It is not, by itself, a measure of whether communication improved, whether practice changed, or whether maternal or neonatal outcomes improved. The registry’s brief summary mentions increasing vaginal delivery rates as a project aim, but the primary endpoint listed is recommendation, not the vaginal delivery rate.
The endpoint is expressed as a percentage, and the registry’s outcome description refers to the qualifying response categories. However, the posted registry record does not report the number of eligible survey respondents, the number recommending the tools, or the resulting percentage. It also does not report an uncertainty interval for that percentage. Without those results, the endpoint’s observed level and its precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record defines a relevant implementation-oriented question: whether clinicians who responded at project midline would recommend the Team Birth Project tools for use in other labor and delivery units. It also gives a specific survey window and a rule for handling repeat surveys. These details clarify what the primary outcome was intended to represent. They do not, however, provide the outcome estimate itself. No recommendation count, survey denominator, percentage, confidence interval, or test result is reported in the registry record.
Consequently, the posted information does not establish how frequently clinicians recommended the tools or how precisely that percentage was estimated. A percentage without its numerator and denominator can be difficult to interpret, and an estimate without an uncertainty interval does not show the range of values compatible with the data under the analysis assumptions. No precision estimate is reported in the registry record. This is a limitation of the available outcome reporting, not evidence that the underlying evaluation did or did not collect the information.
The design also constrains interpretation. The registry identifies a single-group evaluation, gives allocation as NA, and states that the arms are not a like-for-like control comparison. Accordingly, the record does not describe a controlled estimate of what would have happened without the project. Even if an outcome change were reported, a single-group evaluation alone would not separate a project-related change from other explanations, such as changes over time or differences among participating sites. The record does not report an adjusted comparison or a causal analysis.
The registry’s enrollment of 5217 should not be substituted for the primary-outcome survey denominator. The endpoint population is eligible clinicians who responded during the specified window, while the enrollment figure is not identified as that responding population. The number of clinicians approached, eligible, responding, or included in an analysis is not reported in the registry record.
The posted safety information describes facility-level maternal and neonatal event counts, including the serious-event counts and rates listed in the safety record. Those data are distinct from the clinician recommendation endpoint. Because the design is not a like-for-like control comparison, the event figures should not be interpreted as a comparative effect of the project. Overall, the registry record describes the evaluation’s purpose, design, timing, and outcome definitions, but it does not report the primary-outcome result or an analysis from which an effect or precision estimate could be read.
9. Statistical Methods Explained
The registry describes a binary outcome, with the primary measure stated as a percentage of clinicians who would definitely or probably recommend the project tools. The registry also characterizes the outcome parameter as a count of participants. These descriptions indicate that the underlying response information concerns participants and qualifying responses, while the endpoint is presented as a percentage. The numerator, denominator, and observed percentage are not reported in the registry record.
What does a percentage estimate describe?
As a general statistical point, a sample percentage describes the proportion of the analyzed respondents who meet a defined response criterion. Its interpretation depends on a clear definition of who was eligible, who responded, and which responses counted. The record defines the eligible clinician roles and the qualifying recommendation categories, and it specifies a survey window. It also states that the first survey is used when a clinician completed more than one survey in the window. The number of respondents and the observed percentage are not reported, so the estimate cannot be reconstructed or assessed from the record.
What would an uncertainty interval add?
As a general statistical point, a confidence interval communicates the sampling uncertainty around an estimate under a specified statistical model. It is not a guarantee that the true value lies within a particular interval, nor does it address every source of bias. For a survey percentage, uncertainty depends in part on the number of observations and the sampling or analysis structure. The registry record does not report a confidence interval, a standard error, or the analysis details needed to evaluate such an interval. No precision claim about the primary endpoint can therefore be made from the registry information.
What does the single-group design imply?
The study model is listed as single group, allocation is NA, and the record explicitly says that the arms are not a like-for-like control comparison. As a general statistical point, a control group can help distinguish changes associated with an intervention from changes that might have occurred over the same period for other reasons. Without a suitable comparator, descriptive findings can characterize experience at the participating facilities but do not by themselves identify a causal effect. The registry does not report a randomized comparison or a method for adjusting a comparative estimate.
How should planning calculations be read?
The registry’s sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. For time-to-event calculations, the assumptions specify a total event count; for other calculations, they specify participants per arm. These are planning conventions, not a report of the evaluation’s achieved power. The two-arm, equal-allocation assumptions do not describe the registered single-group design. The registry record does not report the study’s own sample-size justification, and the planning assumptions should not be mistaken for that justification or for observed power.
What analysis information is missing?
The record lists 0 analyses. It does not report a statistical analysis plan, the statistical model used for the primary outcome, a treatment of clustering by site, covariate adjustment, a hypothesis test, or an estimate of effect. As a general statistical point, the analysis method should correspond to the outcome scale and study design. For example, a percentage may be analyzed with methods appropriate for binary responses, while a clustered design may require methods that account for similarities among respondents at the same site. The record does not establish which methods, if any, were used, so no method should be inferred.
The stated project goals include improved communication and teamwork and increased vaginal delivery rates. Those goals do not supply results for those outcomes. The primary endpoint remains clinician recommendation, and the record does not give an estimate for it. The safety counts are also not a substitute for an analysis of the primary endpoint or for a controlled estimate of project effects.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures, but it does not describe the relationship between them, identify which other measure is secondary, or provide an analysis plan. It reports 0 analyses. The primary endpoint is identified as the percentage of clinicians who would definitely or probably recommend the project tools, but no result or inferential analysis for that endpoint is reported. The registry record does not report whether any adjustment for multiple outcomes or multiple statistical tests was planned or used.
As a general statistical point, multiplicity arises when several outcomes, comparisons, or analyses are examined. Without an approach to multiplicity, the chance of obtaining at least one apparently unusual result can differ from the chance associated with a single prespecified test. This matters when interpreting claims based on tests across several outcomes. Because the record does not report the analyses or a multiplicity strategy, it is not possible to determine how this issue was handled.
The endpoint population is defined as eligible clinicians who responded during the specified survey window. The record says that the first survey is used if a clinician completed more than one survey in that window. It does not report how many clinicians were eligible, how many responded, whether responses were incomplete, or how missing survey responses were handled. It also does not identify an analysis population beyond the endpoint description. The registered enrollment of 5217 should not be taken as the primary-outcome analysis population.
As a general statistical point, missing responses can affect both the precision and the representativeness of a survey estimate, particularly if response likelihood is related to views about the intervention. The registry does not provide information to assess whether that occurred. The missing-data methods, if any, are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| General Maternal Population (Facility Level) | 328 | 14286 | 2.3% |
| General Neonate Population (Facility Level) | 260 | 11063 | 2.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| General Maternal Population (Facility Level) | 0 of 0 |
| General Neonate Population (Facility Level) | 0 of 0 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| General Maternal Population (Facility Level) | 662 of 7716 |
| General Neonate Population (Facility Level) | 50 of 3737 |
Most frequent serious adverse event terms
| Event term | Organ system | General Maternal Population (Facility Level) | General Neonate Population (Facility Level) |
|---|---|---|---|
| Severe Maternal Morbidity | Pregnancy, puerperium and perinatal conditions | 328 of 14286 | 0 of 0 |
| Severe Unexpected Newborn Complication Rate | General disorders | 0 of 0 | 260 of 11063 |
Most frequent non-serious adverse event terms
| Event term | Organ system | General Maternal Population (Facility Level) | General Neonate Population (Facility Level) |
|---|---|---|---|
| Post Partpartum Hemorrhage | Pregnancy, puerperium and perinatal conditions | 569 of 7716 | 0 of 0 |
| Maternal Blood Transfusion | Pregnancy, puerperium and perinatal conditions | 93 of 7716 | 0 of 0 |
| Overall Unexpected Newborn Complication Rate | General disorders | 0 of 0 | 50 of 3737 |
Serious events with the highest arm-level rate: severe unexpected newborn complication rate (2.4%), severe maternal morbidity (2.3%).
The registry reports facility-level serious and other event counts for a general maternal population and a general neonate population. For the general maternal population, it lists 14286 at risk and 328 affected for serious events, and 7716 at risk and 662 affected for other events; deaths are listed as 0. For the general neonate population, it lists 11063 at risk and 260 affected for serious events, and 3737 at risk and 50 affected for other events; deaths are listed as 0.
The record also lists “Severe Unexpected Newborn Complication Rate” as 2.4% and “Severe Maternal Morbidity” as 2.3% among the top serious terms. These are registry-listed rates; no further calculation is needed to report them. The record does not explain how these terms relate to the event counts or provide a comparative analysis. The counts are facility-level safety information, not the clinician recommendation endpoint. With no like-for-like control comparison identified, these figures do not establish a project-related increase or decrease in serious events.
12. What the Result Does, and Does Not, Mean
The registry record documents a feasibility evaluation of the Team Birth Project and defines a primary outcome focused on clinicians’ willingness to recommend its tools. It specifies which clinician roles were eligible, the timing of the survey window, and how repeat surveys in that window were to be treated. These details make the intended endpoint understandable. The record also identifies the project as a behavioral intervention at an implemented health facility and describes broader aims related to communication, teamwork, and vaginal delivery rates.
However, the primary endpoint’s observed percentage is not reported in the registry record. The number of survey respondents, the number meeting the recommendation criterion, and any confidence interval or test result are also not reported. Therefore, the registry information cannot establish the level of clinician endorsement or the precision of an estimate. It likewise cannot establish whether communication changed or whether vaginal delivery rates changed.
The design is listed as single group, with allocation NA and no masking. The registry cautions that the arms are not a like-for-like control comparison. This means the record does not give a controlled basis for attributing any observed change to the project. The enrollment figure of 5217 describes registered enrollment, not necessarily the population answering the clinician survey or contributing to the primary endpoint.
The facility-level maternal and neonatal event figures provide safety-related information, but they are not a comparison of outcomes between equivalent project and control groups. They should be read as descriptive registry counts and listed rates, not as evidence that the project caused a particular safety outcome. In short, the record tells readers what the evaluation set out to assess and how its primary question was framed, but it does not report the primary result needed to judge the observed recommendation percentage or its precision.
13. Why This Trial Matters Statistically
This evaluation is statistically notable because it distinguishes an implementation question from a clinical outcome question. The primary endpoint asks whether eligible clinicians would recommend the Team Birth Project tools for use in other labor and delivery units. That can inform understanding of acceptability among responding clinicians, but it is not the same as measuring a change in communication, clinical practice, or delivery outcomes. The registry’s broader project aims should therefore not be confused with the endpoint used to assess the primary question.
The outcome definition also highlights the importance of the analysis population. The measure concerns clinicians responding during a site-specific window, with the first survey used if there was more than one response in the window. Yet the record does not report the number eligible or responding, or the resulting recommendation percentage. The enrollment figure of 5217 cannot fill that gap. Keeping these populations distinct is essential when interpreting percentages and judging how well survey responses represent the clinicians at the participating facilities.
The single-group design is another important statistical feature. The registry explicitly notes that the arms are not a like-for-like control comparison. This limits causal interpretation: descriptive findings can characterize the participating setting, but without an appropriate comparator they cannot isolate the project’s effect from other possible influences. This design does not make feasibility questions unimportant; it shapes the kinds of conclusions the evidence can support.
Finally, the registry lists safety information separately from the primary endpoint and reports no analyses. Readers should distinguish descriptive event counts from comparative effects, and planned sample-size illustrations from achieved power. The record’s value is in defining the evaluation and its measurement approach; its statistical interpretability is limited by the absence of primary outcome results and analysis details.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation in the registry record is the absence of the primary-outcome result. Although the endpoint is defined, the record does not report the number of clinicians who responded, the number who would definitely or probably recommend the tools, or the resulting percentage. It also does not report a confidence interval or other measure of precision. This prevents assessment of the observed level of recommendation and its uncertainty.
The registered enrollment of 5217 does not identify the denominator for the clinician survey endpoint. The number of eligible clinicians, the number invited or reached, response rates, and the characteristics of respondents are not reported in the registry record. These omissions make it difficult to judge how representative the survey responses may be. The record specifies a survey window and a first-response rule for repeated surveys, but does not describe other data-cleaning or response-handling procedures.
The single-group model, allocation listed as NA, and explicit warning that the arms are not like-for-like constrain causal interpretation. The record does not report a control-based estimate, adjustment method, or statistical analysis plan. It also does not state how the two outcome measures were handled in analysis or whether multiplicity was addressed. The methods used to account for any grouping of clinicians within sites are not reported.
The safety figures are presented at facility level, but the record does not provide a comparative analysis or enough detail to interpret them as project effects. The registry also does not report a sample-size justification for the evaluation. Planning assumptions described for sample-size illustrations use equal allocation between two arms, whereas the registered evaluation is single group; those assumptions should not be read as the evaluation’s design or as observed power.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Evaluation of the Team Birth Project — NCT03529214.
- Registry record last updated 2025-05-14; status last verified 2025-04.
- Results first posted 2025-05-14.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry identifies NCT03529214 as a completed, single-group evaluation of the Team Birth Project, sponsored by Harvard School of Public Health (HSPH). The registered enrollment is 5217. The study start date is 2018-05-29, and primary completion is recorded as 2019-09-30. Allocation is listed as NA, masking as none, and phase as NA.
The primary endpoint is the percentage of eligible responding clinicians who would definitely or probably recommend the project tools. The survey window is defined as 180 days to 270 days from each site’s start date, with the first survey used if a clinician completed more than one during that window. The registry lists 2 outcome measures and 0 analyses, and does not report a result for the primary endpoint. Facility-level maternal and neonatal safety counts and two serious-event rates are listed, but no like-for-like control comparison is identified.