NCT06926504 TeamBirth-SWE - a Care Process to Improve Safe and Person-centered Intrapartum Care
| NCT ID | NCT06926504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Person Centered Care |
| Study Type | OBSERVATIONAL |
| Enrollment | 800,000 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2028-09-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800,000 participants in total. It began in 2024-02-05 with a primary completion date of 2028-09-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this project is to enhance understanding of intrapartum patient safety and person-centered care through the evaluation of an intervention designed to improve team communication and patient involvement during childbirth, thereby positively impacting maternal and infant health. Despite various efforts to improve safety in intrapartum care, women and their infants are still harmed. Most adverse events within intrapartum care stem from communication and teamwork failures. Despite national and international recommendations, few interventions target patient safety by incorporating person-centered care. This project will investigate the effectiveness and implementation of the TeamBirth care process developed by Ariadne Labs Boston, U.S. to improve communication and teamwork among caregivers and women during childbirth. The Swedish version of this care process (TeamBirth-SWE) was adapted, tested, and piloted at Karolinska University Hospital during 2021. Hypothesis: We hypothesize that the TeamBirth-SWE intervention will have a positive impact on interprofessional teamwork, communication, information sharing, patient involvement, and shared decision-making during labor and birth. These improvements are expected to result in improved maternal and infant outcomes, process measures i.e., patient safety climate, interprofessional collaboration, and improved patient reported measures such as patient involvement, shared-decision-making, and satisfaction with care.
Eligibility Criteria
Inclusion criteria: * Spontaneous onset of labor * Induction of labort * Gestational week \>22+0 Exclusion criteria: * Planned cesarean section * Intrauterine Fetal Demise * Gestational week \<22+0, .
Frequently Asked Questions
Who can join the NCT06926504 clinical trial?
This trial is open to female participants only, aged 15 Years or older, studying Person Centered Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06926504 currently recruiting?
Yes, NCT06926504 is actively recruiting participants. Visit ClinicalTrials.gov or contact Karolinska Institutet to inquire about joining.
Where is the NCT06926504 trial being conducted?
This trial is being conducted at Halmstad, Sweden, Varberg, Sweden, Östersund, Sweden, Lund, Sweden and 3 additional locations.
Who is sponsoring the NCT06926504 clinical trial?
NCT06926504 is sponsored by Karolinska Institutet. The trial plans to enroll 800,000 participants.