Postpartum RecoveryNCT07582289
Labor Epidural Analgesia and Mother-Infant Bonding After Vaginal Delivery
An observational study of Postpartum Recovery and Mother-infant Bonding, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational cohort study aims to evaluate the association between postpartum recovery quality and mother-infant bonding in women undergoing vaginal delivery. Postpartum recovery quality will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire, and mother-infant bonding… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postpartum Recovery, Mother-infant Bonding, Labor Pain
- What is being tested?
- Labor Epidural Analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 17 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with term singleton pregnancy planning vaginal delivery at Atatürk University Research Hospital will be enrolled. Participants will be grouped according to routine clinical labor epidural analgesia preference.
Who may be able to join
- Female participants aged 18 to 40 years
- Term singleton pregnancy (≥37 weeks)
- Planned vaginal delivery
- ASA physical status II
- Ability to understand Turkish
- Written informed consent
Who cannot join
- Contraindications to epidural analgesia including coagulopathy, anticoagulant use, infection, or increased intracranial pressure
- Cesarean delivery
- High-risk pregnancy
- Neonatal intensive care unit requirement
- Major depressive disorder
- Anxiety disorder
- Current psychotropic medication use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ataturk University
Erzurum, 25000
Ayşe Ceren Hilal Güven, assistant doctor, 554-112-25-81, achg1995@gmail.com
About this study
Official title: Association Between Postpartum Recovery Quality Measured by ObsQoR-10 and Mother-Infant Bonding After Vaginal Delivery: The Role of Labor Epidural Analgesia
This prospective observational cohort study aims to evaluate the association between postpartum recovery quality and mother-infant bonding in women undergoing vaginal delivery. Postpartum recovery quality will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire, and mother-infant bonding will be evaluated using the Postpartum Bonding Questionnaire (PBQ).
Participants will be grouped according to routine clinical labor analgesia preference: women receiving labor epidural analgesia and women not receiving epidural analgesia. Additional assessments will include postpartum pain intensity, anxiety, depressive symptoms, and birth satisfaction.
Read more
Baseline psychological assessments will be performed before delivery. The primary postpartum evaluation will be conducted between 6 and 24 hours after delivery. Exploratory follow-up assessments will be performed by telephone during postpartum week 2.
The study aims to better understand the relationship between labor analgesia, postpartum recovery, and early mother-infant bonding outcomes after vaginal delivery.
Read the detailed description
This single-center prospective observational cohort study will be conducted at Atatürk University Research Hospital. The study will include term pregnant women planning vaginal delivery.
Participants will be classified into two cohorts according to routine clinical labor analgesia preference:
Women receiving labor epidural analgesia Women not receiving labor epidural analgesia No experimental intervention will be applied as part of the study protocol. Epidural analgesia, when used, will be administered according to routine clinical practice.
Primary Objective:
To evaluate the association between postpartum recovery quality measured using the ObsQoR-10 questionnaire and mother-infant bonding measured using the Postpartum Bonding Questionnaire (PBQ), and to investigate the role of labor epidural analgesia in this relationship.
Secondary Objectives:
To compare postpartum recovery quality between cohorts To compare mother-infant bonding outcomes between cohorts To evaluate postpartum pain, anxiety, depressive symptoms, and birth satisfaction To assess the association between obstetric variables and postpartum recovery outcomes
Assessments:
Prepartum:
STAIS-5 EPDS
Early postpartum period (6-24 hours):
ObsQoR-10 PBQ STAIS-5 EPDS Pain score (VAS/NRS) Birth satisfaction Likert scale
Postpartum week 2:
PBQ EPDS Participants will provide written informed consent before enrollment. All collected data will be anonymized and analyzed confidentially.
- Conditions
- Postpartum Recovery, Mother-infant Bonding, Labor Pain
- Being tested
- Labor Epidural Analgesia
- Keywords
- Labor Epidural Analgesia, Postpartum Bonding Questionnaire, PBQ, EPDS, STAIS-5, ObsQoR-10, Vaginal Birth, Postpartum Recovery, Maternal Bonding, Obstetric Anesthesia, Postpartum Anxiety, Postpartum Depression
- Medical subject headings
- Labor Pain, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor Epidural AnalgesiaProcedure or surgery
Epidural analgesia administered during labor as part of routine clinical care for pain management during vaginal delivery.
| Study group | Role | What they receive |
|---|---|---|
| Labor Epidural Analgesia | Women undergoing vaginal delivery with labor epidural analgesia as part of routine clinical care. Participants will undergo postpartum recovery, mother-infant bonding, anxiety, depression, pain, and birth satisfaction assessments during the postpartum period. Receives: Procedure: Labor Epidural Analgesia | |
| No Labor Epidural Analgesia | Women undergoing vaginal delivery without labor epidural analgesia as part of routine clinical care. Participants will be evaluated for postpartum recovery quality, mother-infant bonding, anxiety, depressive symptoms, pain intensity, and birth satisfaction during the postpartum period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mother-Infant Bonding Score
Mother-infant bonding will be assessed using the Postpartum Bonding Questionnaire (PBQ), a 25-item scale with a total score ranging from 0 to 125. Lower scores indicate better mother-infant bonding, while higher scores indicate poorer bonding.
Measured: 6 to 24 hours after vaginal delivery
Secondary outcomes (7)
Postpartum Recovery Quality Score
Postpartum recovery quality will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire. Higher scores indicate better postpartum recovery quality.
Measured: 6 to 24 hours after vaginal delivery
Postpartum Pain Intensity
Postpartum pain intensity will be assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS).
Measured: 6 to 24 hours after vaginal delivery
Postpartum Anxiety Level
Postpartum anxiety level will be assessed using the STAIS-5 questionnaire.
Measured: 6 to 24 hours after vaginal delivery
Postpartum Depressive Symptoms
Postpartum depressive symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS).
Measured: 6 to 24 hours after vaginal delivery
Birth Satisfaction Score
Birth satisfaction will be assessed using a 4-point Likert scale.
Measured: 6 to 24 hours after vaginal delivery
Mother-Infant Bonding at Postpartum Week 2
Mother-infant bonding will be reassessed using the Postpartum Bonding Questionnaire (PBQ) during telephone follow-up at postpartum week 2.
Measured: 2 weeks after vaginal delivery
Postpartum Depressive Symptoms at Week 2
Postpartum depressive symptoms will be reassessed using the Edinburgh Postnatal Depression Scale (EPDS) during telephone follow-up at postpartum week 2.
Measured: 2 weeks after vaginal delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start15 May 2026 (estimated)
- Primary completion16 Jun 2029 (estimated)
- Study completion17 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Postpartum RecoveryStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Dostbil, Ataturk University
- Investigators
- Ayşe Ceren Hilal Güven, assistant doctor, Study chair, Ataturk University Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582289
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/234
- Other IDs
- 2026/2
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because of institutional and participant confidentiality policies.
Publications
Doner S, Efe YS, Elmali F. Turkish adaptation of the state-trait anxiety inventory short version (STAIS-5, STAIT-5). Int J Nurs Pract. 2024 Dec;30(6):e13304. doi: 10.1111/ijn.13304. Epub 2024 Sep 25.
PubMed 39323115Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PubMed 3651732Aydin N, Inandi T, Yigit A, Hodoglugil NN. Validation of the Turkish version of the Edinburgh Postnatal Depression Scale among women within their first postpartum year. Soc Psychiatry Psychiatr Epidemiol. 2004 Jun;39(6):483-6. doi: 10.1007/s00127-004-0770-4.
PubMed 15205733Brockington IF, Oates J, George S, et al. A screening questionnaire for mother-infant bonding disorders. Archives of Women's Mental Health. 2001;3(4):133-140. doi:10.1007/s007370170010
Dissiz M, Bayri Bingol F, Demirgoz Bal M, Karacam Yilmaz ZD, Karakoc A, Bilgin Z. The Turkish version of the Postpartum Bonding Questionnaire (PBQ): Examination of the validity and reliability and scale structure. J Pediatr Nurs. 2024 Jul-Aug;77:131-139. doi: 10.1016/j.pedn.2024.03.012. Epub 2024 Mar 21.
PubMed 38518689Bell AF, Andersson E. The birth experience and women's postnatal depression: A systematic review. Midwifery. 2016 Aug;39:112-23. doi: 10.1016/j.midw.2016.04.014. Epub 2016 May 7.
PubMed 27321728Waldenstrom U. Women's memory of childbirth at two months and one year after the birth. Birth. 2003 Dec;30(4):248-54. doi: 10.1046/j.1523-536x.2003.00254.x.
PubMed 14992155Hodnett ED. Pain and women's satisfaction with the experience of childbirth: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S160-72. doi: 10.1067/mob.2002.121141.
PubMed 12011880Labor S, Maguire S. The Pain of Labour. Rev Pain. 2008 Dec;2(2):15-9. doi: 10.1177/204946370800200205.
PubMed 26526404Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
PubMed 29781504Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.
PubMed 12011870Simkin P. Just another day in a woman's life? Women's long-term perceptions of their first birth experience. Part I. Birth. 1991 Dec;18(4):203-10. doi: 10.1111/j.1523-536x.1991.tb00103.x.
PubMed 1764149Feldman R. Mother-infant synchrony and the development of moral orientation in childhood and adolescence: direct and indirect mechanisms of developmental continuity. Am J Orthopsychiatry. 2007 Oct;77(4):582-97. doi: 10.1037/0002-9432.77.4.582.
PubMed 18194038Brockington IF, Fraser C, Wilson D. The Postpartum Bonding Questionnaire: a validation. Arch Womens Ment Health. 2006 Sep;9(5):233-42. doi: 10.1007/s00737-006-0132-1. Epub 2006 May 4.
PubMed 16673041Sultan P, Kamath N, Carvalho B, Bansal P, Elkhateb R, Dougan S, Whittington J, Guo N, El-Sayed Y, Mhyre J, Sharawi N. Evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery-10 patient-reported outcome measure: a single-center observational study. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100202. doi: 10.1016/j.ajogmf.2020.100202. Epub 2020 Aug 17.
PubMed 33345919
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Postpartum Recovery Quality Measured by ObsQoR-10 and Mother-Infant Bonding After Vaginal Delivery: The Role of Labor Epidural Analgesia
- ClinicalTrials.gov ID
- NCT07582289
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/234
- Conditions
- Postpartum Recovery, Mother-infant Bonding, Labor Pain
- Keywords
- Labor Epidural Analgesia, Postpartum Bonding Questionnaire, PBQ, EPDS, STAIS-5, ObsQoR-10, Vaginal Birth, Postpartum Recovery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 16 Jun 2029 (estimated)
- Study completion
- 17 Jun 2029 (estimated)
- First posted
- 12 May 2026 (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.
This prospective observational cohort study aims to evaluate the association between postpartum recovery quality and mother-infant bonding in women undergoing vaginal delivery. Postpartum recovery quality will be assessed using the Obstetric Quality of Recovery-10 (ObsQoR-10) questionnaire, and mother-infant bonding will be evaluated using the Postpartum Bonding Questionnaire (PBQ).
Participants will be grouped according to routine clinical labor analgesia preference: women receiving labor epidural analgesia and women not receiving epidural analgesia. Additional assessments will include postpartum pain intensity, anxiety, depressive symptoms, and birth satisfaction.
Baseline psychological assessments will be performed before delivery. The primary postpartum evaluation will be conducted between 6 and 24 hours after delivery. Exploratory follow-up assessments will be performed by telephone during postpartum week 2.
The study aims to better understand the relationship between labor analgesia, postpartum recovery, and early mother-infant bonding outcomes after vaginal delivery.
Detailed description
This single-center prospective observational cohort study will be conducted at Atatürk University Research Hospital. The study will include term pregnant women planning vaginal delivery.
Participants will be classified into two cohorts according to routine clinical labor analgesia preference:
Women receiving labor epidural analgesia Women not receiving labor epidural analgesia No experimental intervention will be applied as part of the study protocol. Epidural analgesia, when used, will be administered according to routine clinical practice.
Primary Objective:
To evaluate the association between postpartum recovery quality measured using the ObsQoR-10 questionnaire and mother-infant bonding measured using the Postpartum Bonding Questionnaire (PBQ), and to investigate the role of labor epidural analgesia in this relationship.
Secondary Objectives:
To compare postpartum recovery quality between cohorts To compare mother-infant bonding outcomes between cohorts To evaluate postpartum pain, anxiety, depressive symptoms, and birth satisfaction To assess the association between obstetric variables and postpartum recovery outcomes
Assessments:
Prepartum:
STAIS-5 EPDS
Early postpartum period (6-24 hours):
ObsQoR-10 PBQ STAIS-5 EPDS Pain score (VAS/NRS) Birth satisfaction Likert scale
Postpartum week 2:
PBQ EPDS Participants will provide written informed consent before enrollment. All collected data will be anonymized and analyzed confidentially.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labor Epidural Analgesia | – | Procedure: Labor Epidural AnalgesiaWomen undergoing vaginal delivery with labor epidural analgesia as part of routine clinical care. Participants will undergo postpartum recovery, mother-infant bonding, anxiety, depression, pain, and birth satisfaction assessments during the postpartum period. |
| No Labor Epidural Analgesia | – | –Women undergoing vaginal delivery without labor epidural analgesia as part of routine clinical care. Participants will be evaluated for postpartum recovery quality, mother-infant bonding, anxiety, depressive symptoms, pain intensity, and birth satisfaction during the postpartum period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with term singleton pregnancy planning vaginal delivery at Atatürk University Research Hospital will be enrolled. Participants will be grouped according to routine clinical labor epidural analgesia preference.
Key inclusion criteria (6 listed)
- Female participants aged 18 to 40 years
- Term singleton pregnancy (≥37 weeks)
- Planned vaginal delivery
- ASA physical status II
- Ability to understand Turkish
Key exclusion criteria (7 listed)
- Contraindications to epidural analgesia including coagulopathy, anticoagulant use, infection, or increased intracranial pressure
- Cesarean delivery
- High-risk pregnancy
- Neonatal intensive care unit requirement
- Major depressive disorder
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 |
|---|---|---|
| Labor Epidural AnalgesiaEpidural analgesia administered during labor as part of routine clinical care for pain management during vaginal delivery. | Procedure or surgery | Labor Epidural Analgesia |
Primary outcome
Mother-Infant Bonding Score
Time frame: 6 to 24 hours after vaginal delivery
Mother-infant bonding will be assessed using the Postpartum Bonding Questionnaire (PBQ), a 25-item scale with a total score ranging from 0 to 125. Lower scores indicate better mother-infant bonding, while higher scores indicate poorer bonding.
7 secondary outcomes
Postpartum Recovery Quality Score
Time frame: 6 to 24 hours after vaginal delivery
Postpartum Pain Intensity
Time frame: 6 to 24 hours after vaginal delivery
Postpartum Anxiety Level
Time frame: 6 to 24 hours after vaginal delivery
Postpartum Depressive Symptoms
Time frame: 6 to 24 hours after vaginal delivery
Birth Satisfaction Score
Time frame: 6 to 24 hours after vaginal delivery
Mother-Infant Bonding at Postpartum Week 2
Time frame: 2 weeks after vaginal delivery
Postpartum Depressive Symptoms at Week 2
Time frame: 2 weeks after vaginal delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Background: PubMed 39323115Doner S, Efe YS, Elmali F. Turkish adaptation of the state-trait anxiety inventory short version (STAIS-5, STAIT-5). Int J Nurs Pract. 2024 Dec;30(6):e13304. doi: 10.1111/ijn.13304. Epub 2024 Sep 25.
- Background: PubMed 3651732Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Background: PubMed 15205733Aydin N, Inandi T, Yigit A, Hodoglugil NN. Validation of the Turkish version of the Edinburgh Postnatal Depression Scale among women within their first postpartum year. Soc Psychiatry Psychiatr Epidemiol. 2004 Jun;39(6):483-6. doi: 10.1007/s00127-004-0770-4.
- BackgroundBrockington IF, Oates J, George S, et al. A screening questionnaire for mother-infant bonding disorders. Archives of Women's Mental Health. 2001;3(4):133-140. doi:10.1007/s007370170010
- Background: PubMed 38518689Dissiz M, Bayri Bingol F, Demirgoz Bal M, Karacam Yilmaz ZD, Karakoc A, Bilgin Z. The Turkish version of the Postpartum Bonding Questionnaire (PBQ): Examination of the validity and reliability and scale structure. J Pediatr Nurs. 2024 Jul-Aug;77:131-139. doi: 10.1016/j.pedn.2024.03.012. Epub 2024 Mar 21.
- Background: PubMed 27321728Bell AF, Andersson E. The birth experience and women's postnatal depression: A systematic review. Midwifery. 2016 Aug;39:112-23. doi: 10.1016/j.midw.2016.04.014. Epub 2016 May 7.
- Background: PubMed 14992155Waldenstrom U. Women's memory of childbirth at two months and one year after the birth. Birth. 2003 Dec;30(4):248-54. doi: 10.1046/j.1523-536x.2003.00254.x.
- Background: PubMed 12011880Hodnett ED. Pain and women's satisfaction with the experience of childbirth: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S160-72. doi: 10.1067/mob.2002.121141.
- Background: PubMed 26526404Labor S, Maguire S. The Pain of Labour. Rev Pain. 2008 Dec;2(2):15-9. doi: 10.1177/204946370800200205.
- Background: PubMed 29781504Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.
- Background: PubMed 12011870Lowe NK. The nature of labor pain. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S16-24. doi: 10.1067/mob.2002.121427.
- Background: PubMed 1764149Simkin P. Just another day in a woman's life? Women's long-term perceptions of their first birth experience. Part I. Birth. 1991 Dec;18(4):203-10. doi: 10.1111/j.1523-536x.1991.tb00103.x.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because of institutional and participant confidentiality policies.
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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.
Ayşe Ceren Hilal Güven, assistant doctor study chair
Ataturk University Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Recovery and Mother-infant Bonding, run by Ataturk 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 3 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşenur Dostbil, Associate Professor (+90 533 367 66 96, adostbil@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mother-Infant Bonding Score (time frame: 6 to 24 hours after vaginal delivery). 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 NCT07582289, which also lists 17 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 3 Jun 2026.