Supine Hypotensive SyndromeNCT05654324
The Effect of Pelvic Floor Muscle Exercises on the Inferior Vena Cava
A study testing pelvic floor muscle exercises in people with Supine Hypotensive Syndrome, run by Izmir University of Economics at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of pelvic floor muscle exercises on the hemodynamic responses of the vena cava inferior in pregnant and non-pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Supine Hypotensive Syndrome
- What is being tested?
- pelvic floor muscle exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 2 Oct 2023
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Experimental group
- Being pregnant between the ages of 18-40,
- At least primary school graduate and able to read and write,
- The gestational age is 20-40 weeks,
- Not having any mental problems that prevent cooperation and understanding.
- Control group
Show all 9Show fewer
- Being a non-pregnant woman who is in the same age range as the experimental group,
- At least primary school graduate and able to read and write,
- Not having any mental problems that prevent cooperation and understanding.
Who cannot join
- Pregnant women with acute or chronic diseases with poor placental adaptation and vascular damage such as diabetes, chronic arterial hypertension and preeclampsia, as the fetus is closer to the threshold of hypoxia and acidemia and adaptive phenomena may fail,
- Pregnant women with intra-uterine growth restriction and fetal anomaly,
- Pregnant women with cardiovascular disease,
- Pregnant women considered as high risk by the obstetrician,
- Pregnant women with premature, premature birth or miscarriage risk,
- Pregnant women diagnosed with neurological disease,
Show all 13Show fewer
- Obese women (body mass index > 30),
- Women whose IVC measurements cannot be made with ultrasonography,
- Women with severe low back pain (not able to do housework regularly),
- Women who have been diagnosed with a psychiatric illness,
- Women with a history of gynecological surgery,
- Women with pelvic floor dysfunction,
- Women who cannot lie in the supine position.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University İzmir Tepecik Education and Research Hospital Gynecology and Obstetrics Clinic
Izmir
About this study
Official title: Investigation of Acute Effect of Pelvic Floor Muscle Exercises on Inferior Vena Cava
The aim of this study is to examine the effect of pelvic floor muscle exercises on the hemodynamic responses of the vena cava inferior in pregnant and non-pregnant women.
Read the detailed description
The IVC is responsible for approximately two-thirds of the total venous return to the heart. The blood flow in the IVC is affected by the respiratory and cardiac cycle. One of the factors affecting blood flow is pregnancy. Studies have shown that the hemodynamic responses of the IVC may vary depending on the position, and that the supine position puts pressure on the IVC during pregnancy.
Compression of the growing fetus against the IVC can cause supine hypotensive syndrome and fetal danger. However, there is no definite finding about the effects of exercise performed in the supine position. Jefferys et al. reported that the reduction in blood flow at rest is twice that that occurs during exercise and that the level of blood flow should not be a cause for concern in healthy asymptomatic women who choose to exercise in the supine position in late pregnancy. Based on this information, we predict that pelvic floor muscle exercises can change the hemodynamic responses of the IVC and reduce the compression on it.
In order to evaluate the effect of pelvic floor muscle exercises on hemodynamic responses of IVC and compression on it, pregnant and non-pregnant women will be measured by ultrasonography. Women eligible for the study will be seated and rested for 30 minutes before taking the measurement. Then, he will be taken to the supine position, rested for 2 minutes, and the first measurements will be taken at the 3rd minute. pelvic floor muscle exercises will be applied for 5 minutes as stated in the literature. Ultrasonographic measurements will be repeated in the supine position immediately after the pelvic floor exercises and 5 minutes after the exercise. Measurements will be applied to all participants in the same order. During the exercises blood pressure, heart rate and peripheral oxygen saturation will be monitored. Before and after the exercises, the heart rate and blood pressure parameters of the women will be recorded.
- Conditions
- Supine Hypotensive Syndrome
- Being tested
- pelvic floor muscle exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic floor muscle exercisesOther
Before the pelvic floor exercises are taught to all women participating in the study, a brief informational training about the function and structure of the pelvic floor and pelvis will be given using visuals. The application protocol will be given by experienced specialist physiotherapists who have received special training on pelvic floor muscle training. In this study, the training protocol described by Mørkved et al and Bø et al will be used. An exercise series will consist of slow and fast muscle contractions of the pelvic floor muscles. The exercise series will include 10 reps of maximum pelvic floor muscle contraction held for 6 seconds followed by three rapid muscle contractions. A 10-second rest period will be given between each exercise series. A total of 5 minutes, 4 repetitions of pelvic floor muscle contraction series will be applied, including the rest period.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Experimental | Pregnant women aged 18-40, 20-40 weeks of gestation. Receives: Other: pelvic floor muscle exercises |
| Non-Pregnant | Active comparator | Being a non-pregnant woman who is in the same age range as the experimental group. Receives: Other: pelvic floor muscle exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the collapsibility index (%) of IVC
The collapsibility index (%) of IVC will be calculated using the formula:
[(Maximum IVC diameter - Minimum IVC diameter)/Maximum IVC diameter] × 100.
Measured: immediately after the intervention
Change of Pulsatility index of IVC
Doppler (Toshiba Medical Systems, Aplio 400, Berlin) flow velocimetry will be evaluated.
Measured: immediately after the intervention
Changes of IVC diameters
M mode ultrasonography will be used for expiratory (IVC d min) and end-inspiratory (IVC d min) diameter measurement.
Measured: immediately after the intervention
Secondary outcomes (3)
Change of the collapsibility index (%) of IVC
The collapsibility index (%) of IVC will be calculated using the formula:
[(Maximum IVC diameter - Minimum IVC diameter)/Maximum IVC diameter] × 100.
Measured: 5 minutes after the intervention
Change of Pulsatility index of IVC
Doppler (Toshiba Medical Systems, Aplio 400, Berlin) flow velocimetry will be evaluated.
Measured: 5 minutes after the intervention
Changes of IVC diameters
M mode ultrasonography will be used for expiratory (IVC d min) and end-inspiratory (IVC d min) diameter measurement.
Measured: 5 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 May 2023
- Primary completion1 Oct 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Supine Hypotensive SyndromeStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This research is a prospective and controlled study. The data of the study will be collected from pregnant women (Experimental group) and non-pregnant women (Control group).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir University of Economics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Yakit Yesilyurt, Izmir University of Economics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654324
- Sponsor's protocol ID
- İEÜ_SYY
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2022
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klein-Weigel PF, Elitok S, Ruttloff A, Reinhold S, Nielitz J, Steindl J, Lutfi P, Rehmenklau-Bremer L, Hillner B, Fuchs H, Wrase C, Herold T, Beyer L. Inferior vena cava-syndrome. Vasa. 2021 Jul;50(4):250-264. doi: 10.1024/0301-1526/a000919. Epub 2021 Jan 18.
PubMed 33459041Gagne MP, Richebe P, Loubert C, Drolet P, Gobert Q, Denault A, Zaphiratos V. Ultrasound evaluation of inferior vena cava compression in tilted and supine term parturients. Can J Anaesth. 2021 Oct;68(10):1507-1513. doi: 10.1007/s12630-021-02051-w. Epub 2021 Jul 1.
PubMed 34212308Fields JM, Catallo K, Au AK, Rotte M, Leventhal D, Weiner S, Ku BS. Resuscitation of the pregnant patient: What is the effect of patient positioning on inferior vena cava diameter? Resuscitation. 2013 Mar;84(3):304-8. doi: 10.1016/j.resuscitation.2012.11.011. Epub 2012 Nov 21.
PubMed 23178869Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
PubMed 26580836Supine lying during pregnancy. Journal of Pelvic, Obstetric and Gynaecological Physiotherapy. 2018; 122:77-83
Jeffreys RM, Stepanchak W, Lopez B, Hardis J, Clapp JF 3rd. Uterine blood flow during supine rest and exercise after 28 weeks of gestation. BJOG. 2006 Nov;113(11):1239-47. doi: 10.1111/j.1471-0528.2006.01056.x. Epub 2006 Sep 15.
PubMed 16978230Kim DR, Wang E. Prevention of supine hypotensive syndrome in pregnant women treated with transcranial magnetic stimulation. Psychiatry Res. 2014 Aug 15;218(1-2):247-8. doi: 10.1016/j.psychres.2014.04.001. Epub 2014 Apr 12.
PubMed 24768354Finnerty NM, Panchal AR, Boulger C, Vira A, Bischof JJ, Amick C, Way DP, Bahner DP. Inferior Vena Cava Measurement with Ultrasound: What Is the Best View and Best Mode? West J Emerg Med. 2017 Apr;18(3):496-501. doi: 10.5811/westjem.2016.12.32489. Epub 2017 Feb 24.
PubMed 28435502Shailja S, Gupta I, Suri V. Inferior vena cava diameters in pregnant women for prediction of pregnancy-induced hypertension. Int J Gynaecol Obstet. 2004 Feb;84(2):164-5. doi: 10.1016/S0020-7292(03)00157-7. No abstract available.
PubMed 14871520Singh Y, Anand RK, Gupta S, Chowdhury SR, Maitra S, Baidya DK, Singh AK. Role of IVC collapsibility index to predict post spinal hypotension in pregnant women undergoing caesarean section. An observational trial. Saudi J Anaesth. 2019 Oct-Dec;13(4):312-317. doi: 10.4103/sja.SJA_27_19.
PubMed 31572075Dodhy AA. Inferior Vena Cava Collapsibility Index and Central Venous Pressure for Fluid Assessment in the Critically Ill Patient. J Coll Physicians Surg Pak. 2021 Nov;31(11):1273-1277. doi: 10.29271/jcpsp.2021.11.1273.
PubMed 34689482Morkved S, Bo K, Schei B, Salvesen KA. Pelvic floor muscle training during pregnancy to prevent urinary incontinence: a single-blind randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):313-9. doi: 10.1016/s0029-7844(02)02711-4.
PubMed 12576255Yakit Yesilyurt S, Ramazanoglu I, Tosun G, Ozer M, Celiker Tosun O. Does Pelvic Floor Muscle Exercise Change the Hemodynamic Responses of the Inferior Vena Cava in Pregnant Women? A Prospective-Controlled Study. Int Urogynecol J. 2024 Aug;35(8):1653-1662. doi: 10.1007/s00192-024-05860-x. Epub 2024 Jul 4.
PubMed 38963506
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Acute Effect of Pelvic Floor Muscle Exercises on Inferior Vena Cava
- ClinicalTrials.gov ID
- NCT05654324
- Acronym / sponsor ID
- İEÜ_SYY
- Conditions
- Supine Hypotensive Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Izmir University of EconomicsUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 16 Dec 2022 (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.
The aim of this study is to examine the effect of pelvic floor muscle exercises on the hemodynamic responses of the vena cava inferior in pregnant and non-pregnant women.
Detailed description
The IVC is responsible for approximately two-thirds of the total venous return to the heart. The blood flow in the IVC is affected by the respiratory and cardiac cycle. One of the factors affecting blood flow is pregnancy. Studies have shown that the hemodynamic responses of the IVC may vary depending on the position, and that the supine position puts pressure on the IVC during pregnancy.
Compression of the growing fetus against the IVC can cause supine hypotensive syndrome and fetal danger. However, there is no definite finding about the effects of exercise performed in the supine position. Jefferys et al. reported that the reduction in blood flow at rest is twice that that occurs during exercise and that the level of blood flow should not be a cause for concern in healthy asymptomatic women who choose to exercise in the supine position in late pregnancy. Based on this information, we predict that pelvic floor muscle exercises can change the hemodynamic responses of the IVC and reduce the compression on it.
In order to evaluate the effect of pelvic floor muscle exercises on hemodynamic responses of IVC and compression on it, pregnant and non-pregnant women will be measured by ultrasonography. Women eligible for the study will be seated and rested for 30 minutes before taking the measurement. Then, he will be taken to the supine position, rested for 2 minutes, and the first measurements will be taken at the 3rd minute. pelvic floor muscle exercises will be applied for 5 minutes as stated in the literature. Ultrasonographic measurements will be repeated in the supine position immediately after the pelvic floor exercises and 5 minutes after the exercise. Measurements will be applied to all participants in the same order. During the exercises blood pressure, heart rate and peripheral oxygen saturation will be monitored. Before and after the exercises, the heart rate and blood pressure parameters of the women will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This research is a prospective and controlled study. The data of the study will be collected from pregnant women (Experimental group) and non-pregnant women (Control group).
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Experimental | Other: pelvic floor muscle exercisesPregnant women aged 18-40, 20-40 weeks of gestation. |
| Non-Pregnant | Active comparator | Other: pelvic floor muscle exercisesBeing a non-pregnant woman who is in the same age range as the experimental group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Experimental group
- Being pregnant between the ages of 18-40,
- At least primary school graduate and able to read and write,
- The gestational age is 20-40 weeks,
- Not having any mental problems that prevent cooperation and understanding.
Key exclusion criteria (13 listed)
- Pregnant women with acute or chronic diseases with poor placental adaptation and vascular damage such as diabetes, chronic arterial hypertension and preeclampsia, as the fetus is closer to the threshold of hypoxia and acidemia and adaptive phenomena may fail,
- Pregnant women with intra-uterine growth restriction and fetal anomaly,
- Pregnant women with cardiovascular disease,
- Pregnant women considered as high risk by the obstetrician,
- Pregnant women with premature, premature birth or miscarriage risk,
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 |
|---|---|---|
| pelvic floor muscle exercisesBefore the pelvic floor exercises are taught to all women participating in the study, a brief informational training about the function and structure of the pelvic floor and pelvis will be given using visuals. The application protocol will be given by experienced specialist physiotherapists who have received special training on pelvic floor muscle training. In this study, the training protocol described by Mørkved et al and Bø et al will be used. An exercise series will consist of slow and fast muscle contractions of the pelvic floor muscles. The exercise series will include 10 reps of maximum pelvic floor muscle contraction held for 6 seconds followed by three rapid muscle contractions. A 10-second rest period will be given between each exercise series. A total of 5 minutes, 4 repetitions of pelvic floor muscle contraction series will be applied, including the rest period. | Other | Non-Pregnant, Pregnant women |
Primary outcome
Change of the collapsibility index (%) of IVC
Time frame: immediately after the intervention
The collapsibility index (%) of IVC will be calculated using the formula: [(Maximum IVC diameter - Minimum IVC diameter)/Maximum IVC diameter] × 100.
Change of Pulsatility index of IVC
Time frame: immediately after the intervention
Doppler (Toshiba Medical Systems, Aplio 400, Berlin) flow velocimetry will be evaluated.
Changes of IVC diameters
Time frame: immediately after the intervention
M mode ultrasonography will be used for expiratory (IVC d min) and end-inspiratory (IVC d min) diameter measurement.
3 secondary outcomes
Change of the collapsibility index (%) of IVC
Time frame: 5 minutes after the intervention
Change of Pulsatility index of IVC
Time frame: 5 minutes after the intervention
Changes of IVC diameters
Time frame: 5 minutes after the intervention
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 2 Nov 2023.
- Background: PubMed 33459041Klein-Weigel PF, Elitok S, Ruttloff A, Reinhold S, Nielitz J, Steindl J, Lutfi P, Rehmenklau-Bremer L, Hillner B, Fuchs H, Wrase C, Herold T, Beyer L. Inferior vena cava-syndrome. Vasa. 2021 Jul;50(4):250-264. doi: 10.1024/0301-1526/a000919. Epub 2021 Jan 18.
- Background: PubMed 34212308Gagne MP, Richebe P, Loubert C, Drolet P, Gobert Q, Denault A, Zaphiratos V. Ultrasound evaluation of inferior vena cava compression in tilted and supine term parturients. Can J Anaesth. 2021 Oct;68(10):1507-1513. doi: 10.1007/s12630-021-02051-w. Epub 2021 Jul 1.
- Background: PubMed 23178869Fields JM, Catallo K, Au AK, Rotte M, Leventhal D, Weiner S, Ku BS. Resuscitation of the pregnant patient: What is the effect of patient positioning on inferior vena cava diameter? Resuscitation. 2013 Mar;84(3):304-8. doi: 10.1016/j.resuscitation.2012.11.011. Epub 2012 Nov 21.
- Background: PubMed 26580836Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
- BackgroundSupine lying during pregnancy. Journal of Pelvic, Obstetric and Gynaecological Physiotherapy. 2018; 122:77-83
- Background: PubMed 16978230Jeffreys RM, Stepanchak W, Lopez B, Hardis J, Clapp JF 3rd. Uterine blood flow during supine rest and exercise after 28 weeks of gestation. BJOG. 2006 Nov;113(11):1239-47. doi: 10.1111/j.1471-0528.2006.01056.x. Epub 2006 Sep 15.
- Background: PubMed 24768354Kim DR, Wang E. Prevention of supine hypotensive syndrome in pregnant women treated with transcranial magnetic stimulation. Psychiatry Res. 2014 Aug 15;218(1-2):247-8. doi: 10.1016/j.psychres.2014.04.001. Epub 2014 Apr 12.
- Background: PubMed 28435502Finnerty NM, Panchal AR, Boulger C, Vira A, Bischof JJ, Amick C, Way DP, Bahner DP. Inferior Vena Cava Measurement with Ultrasound: What Is the Best View and Best Mode? West J Emerg Med. 2017 Apr;18(3):496-501. doi: 10.5811/westjem.2016.12.32489. Epub 2017 Feb 24.
- Background: PubMed 14871520Shailja S, Gupta I, Suri V. Inferior vena cava diameters in pregnant women for prediction of pregnancy-induced hypertension. Int J Gynaecol Obstet. 2004 Feb;84(2):164-5. doi: 10.1016/S0020-7292(03)00157-7. No abstract available.
- Background: PubMed 31572075Singh Y, Anand RK, Gupta S, Chowdhury SR, Maitra S, Baidya DK, Singh AK. Role of IVC collapsibility index to predict post spinal hypotension in pregnant women undergoing caesarean section. An observational trial. Saudi J Anaesth. 2019 Oct-Dec;13(4):312-317. doi: 10.4103/sja.SJA_27_19.
- Background: PubMed 34689482Dodhy AA. Inferior Vena Cava Collapsibility Index and Central Venous Pressure for Fluid Assessment in the Critically Ill Patient. J Coll Physicians Surg Pak. 2021 Nov;31(11):1273-1277. doi: 10.29271/jcpsp.2021.11.1273.
- Background: PubMed 12576255Morkved S, Bo K, Schei B, Salvesen KA. Pelvic floor muscle training during pregnancy to prevent urinary incontinence: a single-blind randomized controlled trial. Obstet Gynecol. 2003 Feb;101(2):313-9. doi: 10.1016/s0029-7844(02)02711-4.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pelvic floor muscle exercises in people with Supine Hypotensive Syndrome, run by Izmir University of Economics 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 9 inclusion and 13 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 2 Nov 2023. 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?
Change of the collapsibility index (%) of IVC (time frame: immediately after the 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 NCT05654324, which also lists 13 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 2 Nov 2023.