Pregnancy ComplicationsNCT03529214
An Evaluation of the Team Birth Project
A study testing Exposed study site in people with Pregnancy Complications and Cesarean Section Complications, run by Harvard School of Public Health (HSPH) at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pregnancy Complications, Cesarean Section Complications, Maternal Complication of Pregnancy
- What is being tested?
- Exposed study site
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,217 participants
- Where
- 4 sitesUnited States
- Study dates
- 29 May 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinician Participant Inclusion Criteria:
- All clinicians who have practice privileges at a study site
Clinician Participant Exclusion Criteria:
- None
Implementation Team Participant Inclusion Criteria:
- Champions, super-users and others who have been involved in the implementation of "Team Birth Project" at a study site
Implementation Team Participant Exclusion Criteria:
- None
Patient Participant Inclusion Criteria:
- 18 years or older
- Live birth. Includes: spontaneous or induction of labor; Vaginally, with an instruments (forceps / vacuum), or unscheduled cesarean delivery
- Patient at a study site piloting "Team Birth Project"
Patient Participant Exclusion Criteria:
- Under 18 years old
- Scheduled cesarean delivery
- Experienced intrapartum, stillbirth, or neonatal death
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Overlake Medical Center
Bellevue, Washington, 98004
EvergreenHealth Medical Center
Kirkland, Washington, 98034
Saint Francis Hospital
Tulsa, Oklahoma, 74136
South Shore Hospital
Weymouth, Massachusetts, 02190
About this study
Official title: A Program Evaluation to Measure the Feasibility of the Team Birth Project
The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States
Read the detailed description
The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States. TeamBirth is a rigorously designed care process to improve care and SDM across the full care team, which includes the patient, their support person(s), nurse and physician or midwife, by ensuring reliability for best practices in communication and teamwork during labor and delivery. TeamBirth aims to operationalize best practices in communication and clinical care from the major professional organizations in obstetrics, including the American College of Obstetricians \& Gynecologists (ACOG), Society for Maternal-Fetal Medicine (SMFM), American College of Nurse-Midwives (ACNM), and Association of Women's Health, Obstetric, and Neonatal Nurses (AWHONN), to ensure these practices are occurring consistently throughout labor. Key TeamBirth practices include:
- Promoting the roles of the laboring patient, nurse, and delivering provider as members of the care team with equally valuable input for SDM,
- Eliciting the patient's preferences, symptoms, and subjective experiences and integrating them with clinical data to inform patient care plans,
- Distinguishing statuses and care plans for the mother, fetus, and labor progress, and
- Setting shared expectations for the next planned evaluation.
- Conditions
- Pregnancy Complications, Cesarean Section Complications, Maternal Complication of Pregnancy, Communication, Multidisciplinary
- Being tested
- Exposed study site
- Keywords
- Quality Improvement, Program Evaluation, Quality Assurance, Feasibility, Acceptability
- Medical subject headings
- Pregnancy Complications, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposed study siteBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Implemented Health Facility | Other | Health facility that has piloted the "Team Birth Project" Receives: Behavioral: Exposed study site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Clinicians Recommending TeamBirth Project
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.
Measured: 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.
Percent of Patients With the Role They Wanted in Decision-Making
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start29 May 2018
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5,217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Neel Shah, Harvard School of Public Health (HSPH)
- Investigators
- Amber Weiseth, DNP, RN, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529214
- Sponsor's protocol ID
- IRB18-0550
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2018
- Last updated
- 14 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Program Evaluation to Measure the Feasibility of the Team Birth Project
- ClinicalTrials.gov ID
- NCT03529214
- Acronym / sponsor ID
- IRB18-0550
- Conditions
- Pregnancy Complications, Cesarean Section Complications, Maternal Complication of Pregnancy, Communication, Multidisciplinary
- Keywords
- Quality Improvement, Program Evaluation, Quality Assurance, Feasibility, Acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,217 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 29 May 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Posted 14 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States
Detailed description
The purpose of this study is to evaluate the feasibility of a pilot project to improve communication and teamwork and to increase vaginal delivery rates at hospital in the United States. TeamBirth is a rigorously designed care process to improve care and SDM across the full care team, which includes the patient, their support person(s), nurse and physician or midwife, by ensuring reliability for best practices in communication and teamwork during labor and delivery. TeamBirth aims to operationalize best practices in communication and clinical care from the major professional organizations in obstetrics, including the American College of Obstetricians \& Gynecologists (ACOG), Society for Maternal-Fetal Medicine (SMFM), American College of Nurse-Midwives (ACNM), and Association of Women's Health, Obstetric, and Neonatal Nurses (AWHONN), to ensure these practices are occurring consistently throughout labor. Key TeamBirth practices include:
- Promoting the roles of the laboring patient, nurse, and delivering provider as members of the care team with equally valuable input for SDM,
- Eliciting the patient's preferences, symptoms, and subjective experiences and integrating them with clinical data to inform patient care plans,
- Distinguishing statuses and care plans for the mother, fetus, and labor progress, and
- Setting shared expectations for the next planned evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implemented Health Facility | Other | Behavioral: Exposed study siteHealth facility that has piloted the "Team Birth Project" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposed study siteThe 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. | Behavioural | Implemented Health Facility |
Primary outcome
Percent of Clinicians Recommending TeamBirth Project
Time frame: 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.
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.
Percent of Patients With the Role They Wanted in Decision-Making
Time frame: 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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pregnancy Complications
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber Weiseth, DNP, RN principal investigator
Harvard School of Public Health (HSPH)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposed study site in people with Pregnancy Complications and Cesarean Section Complications, run by Harvard School of Public Health (HSPH) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Clinicians Recommending TeamBirth Project (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.