Postpartum HemorrhageNCT06192836
Placental Removal Method And Uterine Massage On Preventing Postpartum Hemorrhage
An observational study of Postpartum Hemorrhage and Cesarean Section Complications, run by Busra Lekesiz at 1 site in Turkey (Türkiye).
Trial summary
Postpartum hemorrhage is the leading cause of maternal deaths in all over the world, especially in developing and underdeveloped countries. Medical and surgical methods exist for management of bleeding. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postpartum Hemorrhage, Cesarean Section Complications, Uterine Atony
- What is being tested?
- Manual Removal 1 and Manual Removal 2
- Type of treatment
- Surgery or procedure
- How many people
- 361 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2024to 14 Jul 2026
- Phase
- Observational
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: In our study, data of patients who underwent emergency cesarean delivery at the Department of Obstetrics and Gynecology, Ankara Etlik City Hospital, will be collected prospectively
Who may be able to join
- Live singleton pregnancy of 37 0/7 weeks or more
- Without history of previous uterine atony
- No comorbidities
- No gestational hypertension or gestational diabetes mellitus
Who cannot join
- In utero fetal death
- Multiple gestation
- History of uterine atony
- Vaginal birth
- Previous history of cesarean delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Placental Removal Method and Uterine Massage at Cesarean Delivery on Preventing Postpartum Hemorrhage
Postpartum hemorrhage is the leading cause of maternal deaths in all over the world, especially in developing and underdeveloped countries. Medical and surgical methods exist for management of bleeding.
There are two surgical techniques for removal of the placenta on cesarean delivery, which are called manual removal and controlled cord traction. In manual removal group, the duration of surgery time might be shorter theoretically. Nevertheless, there are studies showing that manual removal of the placenta may increase postpartum endometritis and postpartum hemorrhage. The optimal method for removal of the placenta during the cesarean delivery remains uncertain (1).
It is a known fact that uterine massage after vaginal birth lowers the risk of postpartum hemorrhage (2) However, there is no study on how effective uterine massage is during cesarean delivery. In 2018, Saccone and colleagues wanted to publish a meta-analysis on the role of uterine massage in reducing postpartum bleeding during cesarean delivery, but when they examined the literature on the subject, they could not find a study which included only the group that gave birth by cesarean section and was free from bias. In the same publication, it was mentioned that it was necessary to investigate the effectiveness of uterine massage, which is a cost-free method that can reduce maternal morbidity in underdeveloped countries where maternal deaths due to postpartum bleeding are high, in cesarean section. (3)
Read the detailed description
In this study, data of patients who underwent emergency cesarean delivery in the Department of Obstetrics and Gynecology, Ankara Etlik City Hospital, will be collected
The parameters to be examined in the research are as follows:
- Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
- Volume of diuresis at postoperative first six hours
- Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
- Duration of the surgery.
- Need for additional dose of uterotonics
- Need for surgical methods to manage postpartum bleeding
- Duration of hospital stay
The sample size of this study was calculated with the Gpower3.1 computer program.
The total number of samples with 90% power and 95% confidence interval was calculated as 338 patients. The number of volunteers to participate in our study is planned to be 360 in total, 60 volunteers for each group, across 6 groups. Results will be considered statistically significant for p< 0,05.
- Being tested
- Manual Removal 1, Manual Removal 2, Controlled Cord Traction 1, Controlled Cord Traction 2, Controlled Cord Traction+Uterine Massage 1
- Keywords
- Postpartum Atony, Uterine massage, Hemorrhage, Placenta, Cesarean
- Medical subject headings
- Postpartum Hemorrhage, Uterine Inertia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Removal 1Procedure or surgery
- Placenta will be removed manually
- Uterine incision will be repaired as double layered
- No uterine massage will be performed
Manual Removal 2Procedure or surgery
- Placenta will be removed manually
- Uterine incision will be repaired as double layered
- Uterine massage will be performed for one minute duration, after uterine incision is closed
Controlled Cord Traction 1Procedure or surgery
- Placenta will be delivered via controlled cord traction
- Uterine incision will be repaired as double layered
- No uterine massage will be performed
Controlled Cord Traction 2Procedure or surgery
- Placenta will be delivered via controlled cord traction
- Uterine incision will be repaired as double layered
- Uterine massage will be performed for one minute duration, after uterine incision is closed
Controlled Cord Traction+Uterine Massage 1Procedure or surgery
- Placenta will be delivered via controlled cord traction plus uterine massage
- Uterine incision will be repaired as double layered
- No uterine massage will be performed after placental delivery
Controlled Cord Traction+Uterine Massage 2Procedure or surgery
- Placenta will be delivered via controlled cord traction plus uterine massage
- Uterine incision will be repaired as double layered
- Additional uterine massage for one minute duration will be performed after uterine incision is closed
| Study group | Role | What they receive |
|---|---|---|
| Group 1- | Operation will be performed by Dr BL
1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay Receives: Procedure: Manual Removal 1 | |
| Group 2 | Operation will be performed by Dr AC
1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay Receives: Procedure: Manual Removal 2 | |
| Group 3 | Operation will be performed by Dr SM
1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay Receives: Procedure: Controlled Cord Traction 1 | |
| Group 4 | Operation will be performed by Dr AS
1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay Receives: Procedure: Controlled Cord Traction 2 | |
| Group 5 | Operation will be performed by Dr EDD
1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay Receives: Procedure: Controlled Cord Traction+Uterine Massage 1 | |
| Group 6 | Operation will be performed by Dr SKE
1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
2. Volume of diuresis at postoperative first six hours
3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
4. Duration of the surgery.
5. Need for additional dose of uterotonics
6. Need for surgical methods to manage postpartum bleeding
7. Duration of hospital stay Receives: Procedure: Controlled Cord Traction+Uterine Massage 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patients' preoperative and postoperative hemoglobin levels
The basal hemoglobin levels ( gr/dL) of the patients will be compared with the hemoglobin levels at 2nd, 6th and 24th hours.
Measured: 24 hours
Comparison of patients' preoperative and postoperative hematocrit levels
The basal hematocrit levels (%) of the patients will be compared with the hematocrit levels at 2nd, 6th and 24th hours
Measured: 24 hours
Comparison of patients' postoperative shock indexes
Postoperative 30th minute, 1st and 2nd hour shock indices (heart rate (beats per minute) / systolic blood pressure(mmHg) ) will be compared
Measured: 2 hours
Secondary outcomes (2)
Comparison of the patients' postoperative heart rate
Patients postoperative 30th minute, 1st and 2nd hour heart rate (beats in minute) will be compared
Measured: 2 hours
Comparison of the patients' postoperative systolic and diastolic blood pressure
Patients postoperative 30th minute, 1st and 2nd hour systolic and diastolic blood pressure (mmHg) will be compared
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Jan 2024
- Primary completion14 Jul 2026
- Study completion14 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Busra Lekesiz
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Busra Lekesiz, Ankara Etlik City Hospital
- Investigators
- Busra Lekesiz, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192836
- Sponsor's protocol ID
- AEŞH-EK1-2023-562
- Status last verified
- Jun 2026
- First submitted
- 21 Dec 2023
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anorlu RI, Maholwana B, Hofmeyr GJ. Methods of delivering the placenta at caesarean section. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD004737. doi: 10.1002/14651858.CD004737.pub2.
PubMed 18646109Hofmeyr GJ, Abdel-Aleem H, Abdel-Aleem MA. Uterine massage for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2013 Jul 1;2013(7):CD006431. doi: 10.1002/14651858.CD006431.pub3.
PubMed 23818022Saccone G, Caissutti C, Ciardulli A, Berghella V. Uterine massage for preventing postpartum hemorrhage at cesarean delivery: Which evidence? Eur J Obstet Gynecol Reprod Biol. 2018 Apr;223:64-67. doi: 10.1016/j.ejogrb.2018.02.023. Epub 2018 Feb 23.
PubMed 29499526
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Placental Removal Method and Uterine Massage at Cesarean Delivery on Preventing Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT06192836
- Acronym / sponsor ID
- AEŞH-EK1-2023-562
- Keywords
- Postpartum Atony, Uterine massage, Hemorrhage, Placenta, Cesarean
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Busra LekesizOther government
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 14 Jul 2026 (actual)
- Study completion
- 14 Jul 2026 (actual)
- First posted
- 5 Jan 2024 (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.
Postpartum hemorrhage is the leading cause of maternal deaths in all over the world, especially in developing and underdeveloped countries. Medical and surgical methods exist for management of bleeding.
There are two surgical techniques for removal of the placenta on cesarean delivery, which are called manual removal and controlled cord traction. In manual removal group, the duration of surgery time might be shorter theoretically. Nevertheless, there are studies showing that manual removal of the placenta may increase postpartum endometritis and postpartum hemorrhage. The optimal method for removal of the placenta during the cesarean delivery remains uncertain (1).
It is a known fact that uterine massage after vaginal birth lowers the risk of postpartum hemorrhage (2) However, there is no study on how effective uterine massage is during cesarean delivery. In 2018, Saccone and colleagues wanted to publish a meta-analysis on the role of uterine massage in reducing postpartum bleeding during cesarean delivery, but when they examined the literature on the subject, they could not find a study which included only the group that gave birth by cesarean section and was free from bias. In the same publication, it was mentioned that it was necessary to investigate the effectiveness of uterine massage, which is a cost-free method that can reduce maternal morbidity in underdeveloped countries where maternal deaths due to postpartum bleeding are high, in cesarean section. (3)
Detailed description
In this study, data of patients who underwent emergency cesarean delivery in the Department of Obstetrics and Gynecology, Ankara Etlik City Hospital, will be collected
The parameters to be examined in the research are as follows:
- Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes
- Volume of diuresis at postoperative first six hours
- Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively.
- Duration of the surgery.
- Need for additional dose of uterotonics
- Need for surgical methods to manage postpartum bleeding
- Duration of hospital stay
The sample size of this study was calculated with the Gpower3.1 computer program.
The total number of samples with 90% power and 95% confidence interval was calculated as 338 patients. The number of volunteers to participate in our study is planned to be 360 in total, 60 volunteers for each group, across 6 groups. Results will be considered statistically significant for p< 0,05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1- | – | Procedure: Manual Removal 1Operation will be performed by Dr BL 1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes 2. Volume of diuresis at postoperative first six hours 3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively. 4. Duration of the surgery. 5. Need for additional dose of uterotonics 6. Need for surgical methods to manage postpartum bleeding 7. Duration of hospital stay |
| Group 2 | – | Procedure: Manual Removal 2Operation will be performed by Dr AC 1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes 2. Volume of diuresis at postoperative first six hours 3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively. 4. Duration of the surgery. 5. Need for additional dose of uterotonics 6. Need for surgical methods to manage postpartum bleeding 7. Duration of hospital stay |
| Group 3 | – | Procedure: Controlled Cord Traction 1Operation will be performed by Dr SM 1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes 2. Volume of diuresis at postoperative first six hours 3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively. 4. Duration of the surgery. 5. Need for additional dose of uterotonics 6. Need for surgical methods to manage postpartum bleeding 7. Duration of hospital stay |
| Group 4 | – | Procedure: Controlled Cord Traction 2Operation will be performed by Dr AS 1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes 2. Volume of diuresis at postoperative first six hours 3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively. 4. Duration of the surgery. 5. Need for additional dose of uterotonics 6. Need for surgical methods to manage postpartum bleeding 7. Duration of hospital stay |
| Group 5 | – | Procedure: Controlled Cord Traction+Uterine Massage 1Operation will be performed by Dr EDD 1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes 2. Volume of diuresis at postoperative first six hours 3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively. 4. Duration of the surgery. 5. Need for additional dose of uterotonics 6. Need for surgical methods to manage postpartum bleeding 7. Duration of hospital stay |
| Group 6 | – | Procedure: Controlled Cord Traction+Uterine Massage 2Operation will be performed by Dr SKE 1. Patients' postoperative 30th minute, 1st and 2nd hour systolic blood pressure, diastolic blood pressure, pulse rate, shock indexes 2. Volume of diuresis at postoperative first six hours 3. Hemoglobin and hematocrit values at preoperatively and 2nd, 6th, 24th hours postoperatively. 4. Duration of the surgery. 5. Need for additional dose of uterotonics 6. Need for surgical methods to manage postpartum bleeding 7. Duration of hospital stay |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- In our study, data of patients who underwent emergency cesarean delivery at the Department of Obstetrics and Gynecology, Ankara Etlik City Hospital, will be collected prospectively
Key inclusion criteria (4 listed)
- Live singleton pregnancy of 37 0/7 weeks or more
- Without history of previous uterine atony
- No comorbidities
- No gestational hypertension or gestational diabetes mellitus
Key exclusion criteria (5 listed)
- In utero fetal death
- Multiple gestation
- History of uterine atony
- Vaginal birth
- Previous history of cesarean delivery
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 |
|---|---|---|
| Manual Removal 11. Placenta will be removed manually 2. Uterine incision will be repaired as double layered 3. No uterine massage will be performed | Procedure or surgery | Group 1- |
| Manual Removal 21. Placenta will be removed manually 2. Uterine incision will be repaired as double layered 3. Uterine massage will be performed for one minute duration, after uterine incision is closed | Procedure or surgery | Group 2 |
| Controlled Cord Traction 11. Placenta will be delivered via controlled cord traction 2. Uterine incision will be repaired as double layered 3. No uterine massage will be performed | Procedure or surgery | Group 3 |
| Controlled Cord Traction 21. Placenta will be delivered via controlled cord traction 2. Uterine incision will be repaired as double layered 3. Uterine massage will be performed for one minute duration, after uterine incision is closed | Procedure or surgery | Group 4 |
| Controlled Cord Traction+Uterine Massage 11. Placenta will be delivered via controlled cord traction plus uterine massage 2. Uterine incision will be repaired as double layered 3. No uterine massage will be performed after placental delivery | Procedure or surgery | Group 5 |
| Controlled Cord Traction+Uterine Massage 21. Placenta will be delivered via controlled cord traction plus uterine massage 2. Uterine incision will be repaired as double layered 3. Additional uterine massage for one minute duration will be performed after uterine incision is closed | Procedure or surgery | Group 6 |
Primary outcome
Comparison of patients' preoperative and postoperative hemoglobin levels
Time frame: 24 hours
The basal hemoglobin levels ( gr/dL) of the patients will be compared with the hemoglobin levels at 2nd, 6th and 24th hours.
Comparison of patients' preoperative and postoperative hematocrit levels
Time frame: 24 hours
The basal hematocrit levels (%) of the patients will be compared with the hematocrit levels at 2nd, 6th and 24th hours
Comparison of patients' postoperative shock indexes
Time frame: 2 hours
Postoperative 30th minute, 1st and 2nd hour shock indices (heart rate (beats per minute) / systolic blood pressure(mmHg) ) will be compared
2 secondary outcomes
Comparison of the patients' postoperative heart rate
Time frame: 2 hours
Comparison of the patients' postoperative systolic and diastolic blood pressure
Time frame: 2 hours
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 2026.
- Background: PubMed 18646109Anorlu RI, Maholwana B, Hofmeyr GJ. Methods of delivering the placenta at caesarean section. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD004737. doi: 10.1002/14651858.CD004737.pub2.
- Background: PubMed 23818022Hofmeyr GJ, Abdel-Aleem H, Abdel-Aleem MA. Uterine massage for preventing postpartum haemorrhage. Cochrane Database Syst Rev. 2013 Jul 1;2013(7):CD006431. doi: 10.1002/14651858.CD006431.pub3.
- Background: PubMed 29499526Saccone G, Caissutti C, Ciardulli A, Berghella V. Uterine massage for preventing postpartum hemorrhage at cesarean delivery: Which evidence? Eur J Obstet Gynecol Reprod Biol. 2018 Apr;223:64-67. doi: 10.1016/j.ejogrb.2018.02.023. Epub 2018 Feb 23.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Busra Lekesiz principal investigator
Ankara Etlik City Hospital
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 Hemorrhage and Cesarean Section Complications, run by Busra Lekesiz 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 4 inclusion and 5 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 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?
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?
Comparison of patients' preoperative and postoperative hemoglobin levels (time frame: 24 hours). 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 NCT06192836, which also lists 3 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 2026; AzTrials last refreshed its copy on 7 Nov 2026.