Shoulder DystociaNCT07009626
Simulation in Shoulder Dystocia Management
A study testing Computer-based high-validity birth simulator in people with Shoulder Dystocia and Simulation Based Medical Education, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Shoulder dystocia is an unpredictable and unpredictable emergency obstetric condition that causes serious maternal and neonatal complications. Therefore, it requires immediate and effective intervention. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Shoulder Dystocia, Simulation Based Medical Education, Midwifery
- What is being tested?
- Computer-based high-validity birth simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Registered in the midwifery department,
- Attending the risky birth and postpartum period course,
- Agreeing to participate in the study
Who cannot join
- Those who have previously taken the risky birth and postpartum period course and failed the course,
- Those who did not attend the shoulder dystocia management course,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Simulation in Shoulder Dystocia Management Education: A Randomized-Controlled Trial
Shoulder dystocia is an unpredictable and unpredictable emergency obstetric condition that causes serious maternal and neonatal complications. Therefore, it requires immediate and effective intervention. It is known as the condition in which the shoulders cannot be released from the pelvis and remain stuck after the fetal head is born during delivery. Fetal macrosomia is shown as the most important risk factor for shoulder dystocia. The intervention to be performed for shoulder dystocia should start from the least invasive and progress to the more invasive. Detection and management of shoulder dystocia requires sufficient technical knowledge, skills and experience. Simulation-based learning in midwifery education and practice provides students with the opportunity to manage and develop skills in many risky situations close to reality outside the hospital environment. In addition, the fact that the application can be repeated many times without harming people also affects the anxiety and self-efficacy levels of students before real clinical experience. As a result, it is understood that shoulder dystocia is an important condition that cannot be predicted and prevented, has very serious maternal and neonatal consequences, and a systematic approach should be used in its prevention, early diagnosis and management. The aim of this study is to evaluate the effect of a computer-based simulation training model on the knowledge level, management skills and anxiety levels of midwifery students about shoulder dystocia. The study will be conducted with all students enrolled in the "Risky Birth and Postpartum Period" course at the Department of Midwifery, Faculty of Health Sciences, Sakarya University in the 2024-2025 academic year. Data in the study will be collected through the Student Identification Form, Shoulder Dystocia and Management Information Form, Shoulder Dystocia Management Individual Assessment Form and Shoulder Dystocia Management Skills Assessment Form. The analysis of the data obtained from the study will be done with the SPSS program. It is thought that the study will make a significant contribution to the literature in terms of evaluating the effect of the computer-based simulation training model on shoulder dystocia management.
Read the detailed description
Shoulder dystocia is defined as failure to deliver the shoulders after the delivery of the fetal head. This condition may occur as a result of a mismatch between the fetal shoulder size and the pelvic inlet, and may develop as an anterior or posterior shoulder attachment, or it may be seen in both shoulders. This condition is an unpredictable and unavoidable obstetric emergency, occurring in 0.6% to 1.4% of births. Shoulder dystocia usually includes risk factors such as maternal obesity, fetal macrosomia, maternal diabetes, prolonged labor, advanced age, use of epidural anesthesia, and a history of dystocia in previous births. Transient brachial plexus injury (BPI) is the most common fetal complication due to shoulder dystocia. Other fetal complications include clavicle and humerus injuries, permanent BPI, hypoxic ischemic encephalopathy and death. Maternal complications can lead to vaginal and cervical lacerations, postpartum hemorrhage, II.-III.-IV. degree perineal tears, and even late-term fistulas. Therefore, it is vital to know the risk factors in advance and to ensure the order of maneuvers to be performed and the correct application skills for difficult births that occur. Simulation education has been used in the health field for many years. Simulators help with rapid critical thinking and management of situations that cause confusion. In skill-based midwifery education, simulation-based learning focuses on many risky situations such as postpartum hemorrhage, shoulder impingement, and emergency breech delivery. The use of computer-based simulators allows students to practice and develop their skills in an environment that is almost like a hospital before going to hospital practice. Computer-based simulators are quite educational for students because they provide opportunities for realistic errors and realistic error attempts. Simulators are also known to increase learning satisfaction, improve communication skills and increase self-efficacy. In this study, it was aimed to evaluate the effect of the computer-based simulation training model on the knowledge level, management skills and anxiety levels of midwifery students about shoulder dystocia.
- Being tested
- Computer-based high-validity birth simulator
- Keywords
- shoulder dystocia, simulation, midwifery education, anxiety
- Medical subject headings
- Shoulder Dystocia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based high-validity birth simulatorOther
Computer-based high-validity birth simulator: All students in the intervention group underwent the same scenario of birth. Initially, the aim was to diagnose shoulder dystocia by ensuring that the shoulders were not delivered after the fetal head was delivered.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Control group: The instructor will position the pelvic mannequin so that the fetus is in vertex presentation. A person independent of the research and training will facilitate the descent of the baby into the pelvic mannequin. After the delivery of the baby's head, the baby's descent will be stopped and the instructor will not allow the baby to be born. Each student will be given the opportunity to practice the process on the mannequin according to the steps of shoulder dystocia management. Each practice session will last approximately 10 minutes. The researcher will observe each student and provide feedback on their performance, including discussion of any errors made. |
| Computer-based high-validity birth simulator group | Experimental | Computer-based high-validity birth simulator group: The instructor will place the fetus in a computer-based full-body birthing manikin in vertex presentation. In addition, the pregnant woman will be vocalized to increase realism and the patient's vital signs, fetal heart rate, etc. will be displayed on the patient monitor. The same scenario will be initiated for each student in the simulation group. Each student will be given the opportunity to practice the process on the simulation model in accordance with the shoulder dystocia delivery management steps. Each practice session will last 15-20 minutes. The researcher will observe each student and provide feedback on their performance, including discussion of any errors made. Receives: Other: Computer-based high-validity birth simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Dystocia and Management Information Form
This is a questionnaire form developed by researchers in line with the information in the guide developed by RCOG for the management of shoulder dystocia. This form, which will be applied before and after the training, consists of 18 questions. It was used to determine the knowledge levels of students about shoulder dystocia and its management. One point was given for each correct answer given to the questions in the survey. The maximum total score that can be obtained is 18. Students will mark the questions in the shoulder dystocia and its management information form as true, false or I have no idea.
Measured: pre-intervention, 1 hour after intervention
State Anxiety Inventory
The inventory developed by Spielberger and colleagues (1970) is a self-assessment questionnaire consisting of short assessments (Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983). The validity and reliability of the inventory in Turkey was conducted by Öner and Lecompte (1983) (Öner \& Le Compte, 1983). The State Anxiety Inventory consists of 20 items and requires the individual to answer how he/she feels at a certain moment and under certain conditions, taking into account his/her feelings about the situation he/she is in. The scale is a Likert-type scale with four points ranging from "Not at all" to "Completely". High scores indicate a high level of anxiety, and low scores indicate a low level of anxiety. In the validity and reliability study of the inventory, the Cronbach Alpha coefficient for the SAI was between 0.94 and 0.96 (Öner \& Le Compte, 1983).
Measured: pre-intervention, 1 hour after intervention
Shoulder Dystocia Management Skills Assessment Form
It is a form that evaluates students' implementation of the steps in shoulder dystocia management.
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start15 Apr 2025
- Primary completion15 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Shoulder DystociaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yasemin hamlacı başkaya, Sakarya University
- Investigators
- Yasemin Hamlacı Başkaya, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009626
- Sponsor's protocol ID
- 28052025
- Status last verified
- Jul 2025
- First submitted
- 28 May 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grobman WA. Shoulder dystocia: simulation and a team-centered protocol. Semin Perinatol. 2014 Jun;38(4):205-9. doi: 10.1053/j.semperi.2014.04.006.
PubMed 24863026Gurewitsch Allen ED. Simulation of Shoulder Dystocia for Skill Acquisition and Competency Assessment: A Systematic Review and Gap Analysis. Simul Healthc. 2018 Aug;13(4):268-283. doi: 10.1097/SIH.0000000000000292.
PubMed 29381590Hill DA, Lense J, Roepcke F. Shoulder Dystocia: Managing an Obstetric Emergency. Am Fam Physician. 2020 Jul 15;102(2):84-90.
PubMed 32667171Hill MG, Cohen WR. Shoulder dystocia: prediction and management. Womens Health (Lond). 2016;12(2):251-61. doi: 10.2217/whe.15.103. Epub 2016 Feb 22.
PubMed 26901875Behram, M., ve Eyi, EGY. Vajinal Doğum Sırasında Omuz Distosisi Gelişen Olguların Değerlendirilmesi. Internatıonal Anatolıa Academıc Onlıne Journal, Health Scıences, 2021; 7(2), 109-118.
Nassar AK, Al-Manaseer F, Knowlton LM, Tuma F. Virtual reality (VR) as a simulation modality for technical skills acquisition. Ann Med Surg (Lond). 2021 Oct 27;71:102945. doi: 10.1016/j.amsu.2021.102945. eCollection 2021 Nov.
PubMed 34840738Padilha JM, Machado PP, Ribeiro A, Ramos J, Costa P. Clinical Virtual Simulation in Nursing Education: Randomized Controlled Trial. J Med Internet Res. 2019 Mar 18;21(3):e11529. doi: 10.2196/11529.
PubMed 30882355Şenoğlu, A., ve Karaçam, Z. Omuz Distosisi: Ebelik Eğitim ve Uygulamalarındaki Yeri. Lokman Hekim Dergisi, 2019;9 (2): 147-159 DOI: 10.31020/mutftd.522365
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Simulation in Shoulder Dystocia Management Education: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT07009626
- Acronym / sponsor ID
- 28052025
- Keywords
- shoulder dystocia, simulation, midwifery education, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shoulder dystocia is an unpredictable and unpredictable emergency obstetric condition that causes serious maternal and neonatal complications. Therefore, it requires immediate and effective intervention. It is known as the condition in which the shoulders cannot be released from the pelvis and remain stuck after the fetal head is born during delivery. Fetal macrosomia is shown as the most important risk factor for shoulder dystocia. The intervention to be performed for shoulder dystocia should start from the least invasive and progress to the more invasive. Detection and management of shoulder dystocia requires sufficient technical knowledge, skills and experience. Simulation-based learning in midwifery education and practice provides students with the opportunity to manage and develop skills in many risky situations close to reality outside the hospital environment. In addition, the fact that the application can be repeated many times without harming people also affects the anxiety and self-efficacy levels of students before real clinical experience. As a result, it is understood that shoulder dystocia is an important condition that cannot be predicted and prevented, has very serious maternal and neonatal consequences, and a systematic approach should be used in its prevention, early diagnosis and management. The aim of this study is to evaluate the effect of a computer-based simulation training model on the knowledge level, management skills and anxiety levels of midwifery students about shoulder dystocia. The study will be conducted with all students enrolled in the "Risky Birth and Postpartum Period" course at the Department of Midwifery, Faculty of Health Sciences, Sakarya University in the 2024-2025 academic year. Data in the study will be collected through the Student Identification Form, Shoulder Dystocia and Management Information Form, Shoulder Dystocia Management Individual Assessment Form and Shoulder Dystocia Management Skills Assessment Form. The analysis of the data obtained from the study will be done with the SPSS program. It is thought that the study will make a significant contribution to the literature in terms of evaluating the effect of the computer-based simulation training model on shoulder dystocia management.
Detailed description
Shoulder dystocia is defined as failure to deliver the shoulders after the delivery of the fetal head. This condition may occur as a result of a mismatch between the fetal shoulder size and the pelvic inlet, and may develop as an anterior or posterior shoulder attachment, or it may be seen in both shoulders. This condition is an unpredictable and unavoidable obstetric emergency, occurring in 0.6% to 1.4% of births. Shoulder dystocia usually includes risk factors such as maternal obesity, fetal macrosomia, maternal diabetes, prolonged labor, advanced age, use of epidural anesthesia, and a history of dystocia in previous births. Transient brachial plexus injury (BPI) is the most common fetal complication due to shoulder dystocia. Other fetal complications include clavicle and humerus injuries, permanent BPI, hypoxic ischemic encephalopathy and death. Maternal complications can lead to vaginal and cervical lacerations, postpartum hemorrhage, II.-III.-IV. degree perineal tears, and even late-term fistulas. Therefore, it is vital to know the risk factors in advance and to ensure the order of maneuvers to be performed and the correct application skills for difficult births that occur. Simulation education has been used in the health field for many years. Simulators help with rapid critical thinking and management of situations that cause confusion. In skill-based midwifery education, simulation-based learning focuses on many risky situations such as postpartum hemorrhage, shoulder impingement, and emergency breech delivery. The use of computer-based simulators allows students to practice and develop their skills in an environment that is almost like a hospital before going to hospital practice. Computer-based simulators are quite educational for students because they provide opportunities for realistic errors and realistic error attempts. Simulators are also known to increase learning satisfaction, improve communication skills and increase self-efficacy. In this study, it was aimed to evaluate the effect of the computer-based simulation training model on the knowledge level, management skills and anxiety levels of midwifery students about shoulder dystocia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group: The instructor will position the pelvic mannequin so that the fetus is in vertex presentation. A person independent of the research and training will facilitate the descent of the baby into the pelvic mannequin. After the delivery of the baby's head, the baby's descent will be stopped and the instructor will not allow the baby to be born. Each student will be given the opportunity to practice the process on the mannequin according to the steps of shoulder dystocia management. Each practice session will last approximately 10 minutes. The researcher will observe each student and provide feedback on their performance, including discussion of any errors made. |
| Computer-based high-validity birth simulator group | Experimental | Other: Computer-based high-validity birth simulatorComputer-based high-validity birth simulator group: The instructor will place the fetus in a computer-based full-body birthing manikin in vertex presentation. In addition, the pregnant woman will be vocalized to increase realism and the patient's vital signs, fetal heart rate, etc. will be displayed on the patient monitor. The same scenario will be initiated for each student in the simulation group. Each student will be given the opportunity to practice the process on the simulation model in accordance with the shoulder dystocia delivery management steps. Each practice session will last 15-20 minutes. The researcher will observe each student and provide feedback on their performance, including discussion of any errors made. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Registered in the midwifery department,
- Attending the risky birth and postpartum period course,
- Agreeing to participate in the study
Key exclusion criteria (2 listed)
- Those who have previously taken the risky birth and postpartum period course and failed the course,
- Those who did not attend the shoulder dystocia management course,
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 |
|---|---|---|
| Computer-based high-validity birth simulatorComputer-based high-validity birth simulator: All students in the intervention group underwent the same scenario of birth. Initially, the aim was to diagnose shoulder dystocia by ensuring that the shoulders were not delivered after the fetal head was delivered. | Other | Computer-based high-validity birth simulator group |
Primary outcome
Shoulder Dystocia and Management Information Form
Time frame: pre-intervention, 1 hour after intervention
This is a questionnaire form developed by researchers in line with the information in the guide developed by RCOG for the management of shoulder dystocia. This form, which will be applied before and after the training, consists of 18 questions. It was used to determine the knowledge levels of students about shoulder dystocia and its management. One point was given for each correct answer given to the questions in the survey. The maximum total score that can be obtained is 18. Students will mark the questions in the shoulder dystocia and its management information form as true, false or I have no idea.
State Anxiety Inventory
Time frame: pre-intervention, 1 hour after intervention
The inventory developed by Spielberger and colleagues (1970) is a self-assessment questionnaire consisting of short assessments (Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983). The validity and reliability of the inventory in Turkey was conducted by Öner and Lecompte (1983) (Öner \& Le Compte, 1983). The State Anxiety Inventory consists of 20 items and requires the individual to answer how he/she feels at a certain moment and under certain conditions, taking into account his/her feelings about the situation he/she is in. The scale is a Likert-type scale with four points ranging from "Not at all" to "Completely". High scores indicate a high level of anxiety, and low scores indicate a low level of anxiety. In the validity and reliability study of the inventory, the Cronbach Alpha coefficient for the SAI was between 0.94 and 0.96 (Öner \& Le Compte, 1983).
Shoulder Dystocia Management Skills Assessment Form
Time frame: 1 hours
It is a form that evaluates students' implementation of the steps in shoulder dystocia management.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Background: PubMed 24863026Grobman WA. Shoulder dystocia: simulation and a team-centered protocol. Semin Perinatol. 2014 Jun;38(4):205-9. doi: 10.1053/j.semperi.2014.04.006.
- Background: PubMed 29381590Gurewitsch Allen ED. Simulation of Shoulder Dystocia for Skill Acquisition and Competency Assessment: A Systematic Review and Gap Analysis. Simul Healthc. 2018 Aug;13(4):268-283. doi: 10.1097/SIH.0000000000000292.
- Background: PubMed 32667171Hill DA, Lense J, Roepcke F. Shoulder Dystocia: Managing an Obstetric Emergency. Am Fam Physician. 2020 Jul 15;102(2):84-90.
- Background: PubMed 26901875Hill MG, Cohen WR. Shoulder dystocia: prediction and management. Womens Health (Lond). 2016;12(2):251-61. doi: 10.2217/whe.15.103. Epub 2016 Feb 22.
- BackgroundBehram, M., ve Eyi, EGY. Vajinal Doğum Sırasında Omuz Distosisi Gelişen Olguların Değerlendirilmesi. Internatıonal Anatolıa Academıc Onlıne Journal, Health Scıences, 2021; 7(2), 109-118.
- Background: PubMed 34840738Nassar AK, Al-Manaseer F, Knowlton LM, Tuma F. Virtual reality (VR) as a simulation modality for technical skills acquisition. Ann Med Surg (Lond). 2021 Oct 27;71:102945. doi: 10.1016/j.amsu.2021.102945. eCollection 2021 Nov.
- Background: PubMed 30882355Padilha JM, Machado PP, Ribeiro A, Ramos J, Costa P. Clinical Virtual Simulation in Nursing Education: Randomized Controlled Trial. J Med Internet Res. 2019 Mar 18;21(3):e11529. doi: 10.2196/11529.
- BackgroundŞenoğlu, A., ve Karaçam, Z. Omuz Distosisi: Ebelik Eğitim ve Uygulamalarındaki Yeri. Lokman Hekim Dergisi, 2019;9 (2): 147-159 DOI: 10.31020/mutftd.522365
- Individual participant dataSharing planned: No
Related trials for Shoulder Dystocia
Not yet recruiting
TelesDystocia: Tele-Support vs. Cognitive Aid in Simulated Shoulder Dystocia
Shoulder Dystocia
Not yet recruitingObservational study
Evalution of the Effectiveness of a Shoulder Dystocia Training Program Designed With Inverted Learning Supported by Generative Artificial Intelligence
Shoulder Dystocia Training Using AI-supported Flipped Learning in Midwifery Education
Recruiting
Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
Shoulder Dystocia
RecruitingObservational study
Role of HbA1c in Predicting Adverse Pregnancy Outcomes
Gestational Diabetes
Not yet recruitingObservational study
Fetal Clavicular Measurement to Predict Fetal Macrosomia
Macrosomia, Fetal, Large for Gestational Age
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.
Yasemin Hamlacı Başkaya principal investigator
Sakarya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-based high-validity birth simulator in people with Shoulder Dystocia and Simulation Based Medical Education, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Shoulder Dystocia and Management Information Form (time frame: pre-intervention, 1 hour after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07009626, which also lists 8 linked publications.
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 15 Jul 2025.