PregnancyNCT01990625
A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings
A study testing Antenatal Ultrasound Scan in people with Pregnancy and Eclampsia, run by NICHD Global Network for Women's and Children's Health at 5 sites in 5 countries.
Trial summary
In many low-income countries, the use of ultrasound by medical officers and non-physician health care staff (e.g., midwives) for antenatal identification of high risk pregnancies is a new intervention requiring authoritative investigation. Read more about this study
- Who is it for?
- Ages 12 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Eclampsia, Placenta Previa
- What is being tested?
- Antenatal Ultrasound Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45,038 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Apr 2014to Sep 2016
- 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 12 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women who provide consent
- Resident of study cluster
- Enrolled/eligible for the Global Network Maternal and Neonatal Health Registry
- Women >16 weeks gestation at enrollment
Who cannot join
- Women who are in labor at time of consent
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Republic of the Congo1 site
Kinshasa School of Public Health
Gemena, Equateur
About this study
Official title: Global Network First Look: A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings
In many low-income countries, the use of ultrasound by medical officers and non-physician health care staff (e.g., midwives) for antenatal identification of high risk pregnancies is a new intervention requiring authoritative investigation. The primary hypothesis to be assessed in this study is that antenatal ultrasound screenings performed by medical officers and non-physician health care staff will significantly reduce a composite outcome consisting of maternal mortality and maternal near miss, stillbirth and neonatal mortality in low-resource settings. Underpinning this hypothesis are two assumptions. The first assumption is that antenatal detection of complicated pregnancies will lead to appropriate referral at the right time for complicated pregnancies to comprehensive emergency obstetric and neonatal care (EmONC) facilities. The second assumption is that ultrasound's introduction will increase antenatal attendance leading to greater rates of institutional delivery. To assess these underlying assumptions beyond the composite end point, this study will investigate the health system impact of compact ultrasound. Secondary outcomes include antenatal attendance rates, institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC facilities, cesarean section rates (both planned and emergent) and an assessment of medical officers and non-physician health care provider ultrasound competence and training quality.
Read the detailed description
The use of ultrasound by physician and non-physician health care staff for antenatal identification of complicated pregnancies is a potentially effective intervention; however, authoritative investigation in many low-resource settings is needed to establish its potential impact. The investigators propose to undertake a multi-country, cluster randomized trial to assess the impact of antenatal ultrasound screening performed by community physician and non-physician health care staff on a composite outcome consisting of maternal mortality and near miss maternal mortality, stillbirth and neonatal mortality in low-resource settings. Underpinning this objective are several assumptions. The first assumption is that ultrasound's introduction will increase antenatal attendance and improved outcomes due to the antenatal care alone, and greater rates of institutional delivery. The second assumption is that ultrasound use will lead to antenatal detection of complicated pregnancies and timely and appropriate referral for complicated pregnancies to comprehensive emergency obstetric and neonatal care (EmONC) facilities. Increases in antenatal care utilization and referral will result in a decrease in a composite outcome including maternal mortality and near miss mortality, stillbirth and neonatal death. Secondary outcomes to be evaluated include antenatal attendance rates, institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC facilities, cesarean section rates (both planned and emergent), an assessment of community physician and non-physician health care provider ultrasound training and competence and the cost-effectiveness of ultrasound in community health facilities. The investigators will also determine causes for non-compliance with recommendations for referral.
In summary, this trial will evaluate whether training antenatal health care providers to perform basic obstetric ultrasonography, and using these trainees to provide routine ultrasounds in primary care clinics and to refer appropriately will improve pregnancy outcomes in low-resource settings.
To assess the impact of ultrasound, the investigators propose to utilize an existing research infrastructure, the Global Network for Women's and Children's Health Research (Global Network), which currently includes 7 sites in 6 countries, India (2), Pakistan, Kenya, Zambia, DRC and Guatemala. The investigators of the Global Network have an ongoing maternal and newborn health registry to document all pregnancies and their outcomes to 6 weeks post-delivery in more than 100 communities. Thus, population-based rates of maternal mortality and morbidity, stillbirth, and neonatal mortality and morbidity, as well as health care utilization, are being obtained. A sub-set of these clusters will be utilized for the ultrasound trial.
RTI International serves as the data coordinating center for the Global Network to help facilitate the design and conduct of the trial, manage the trial related data, and provide statistical analyses of the trial results. GE Healthcare will provide the ultrasound equipment, and will also fund the University of Washington to provide training and technical support on the implementation of ultrasound in community settings. Together, the Global Network with the support of the University of Washington and GE Healthcare will maximize the resources necessary to conduct a definitive trial on the potential impact of ultrasound to reduce maternal and newborn mortality and maternal morbidity in low-resource settings.
- Conditions
- Pregnancy, Eclampsia, Placenta Previa, Stillbirth, Fetal Growth Restriction
- Being tested
- Antenatal Ultrasound Scan
- Keywords
- Maternal Near Miss Morbidity, Maternal Mortality, Neonatal Mortality, Gestational Age Dating, Pregnancy Complications, Ultrasound, Stillbirth
- Medical subject headings
- Eclampsia, Placenta Previa, Stillbirth, Fetal Growth Retardation, Maternal Death, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal Ultrasound ScanDevice
Women in the intervention arm will be provided two ultrasound scans to screen for pregnancy complications.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound scan | Experimental | The group is pregnant women who reside in an intervention cluster who receive at least one antenatal ultrasound scan during antenatal care during the study time period. Receives: Device: Antenatal Ultrasound Scan |
| Routine antenatal care | No intervention | The group is pregnant women that reside in the control clusters during the study time period. The group received routine antenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome
Introduction of ultrasound will decrease the composite outcome of maternal mortality and near miss maternal mortality events and stillbirths plus early neonatal mortality.
Measured: Up to 30 months
Secondary outcomes (1)
Rate of Women with Complicated Deliveries at Health Facilities
Introduction of ultrasound will significantly increase the percentage of women with complicated pregnancies such as twins, breeches, etc. who deliver in a hospital.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45,038 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Bill and Melinda Gates Foundation, GE Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990625
- Sponsor's protocol ID
- GN First Look Ultrasound
- Status last verified
- Sep 2016
- First submitted
- 15 Nov 2013
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nathan R, Swanson JO, Marks W, Goldsmith N, Vance C, Sserwanga NB, Swanson D, McClure EM, Franklin H, Mirza W, Mwenechanya M, Muyodi D, Figuero L, Bolamba VL, Goldenberg RL, Pineda IS. Screening obstetric ultrasound training for a 5-country cluster randomized controlled trial. Ultrasound Q. 2014 Dec;30(4):262-6. doi: 10.1097/RUQ.0000000000000096.
PubMed 25415862McClure EM, Nathan RO, Saleem S, Esamai F, Garces A, Chomba E, Tshefu A, Swanson D, Mabeya H, Figuero L, Mirza W, Muyodi D, Franklin H, Lokangaka A, Bidashimwa D, Pasha O, Mwenechanya M, Bose CL, Carlo WA, Hambidge KM, Liechty EA, Krebs N, Wallace DD, Swanson J, Koso-Thomas M, Widmer R, Goldenberg RL. First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings. BMC Pregnancy Childbirth. 2014 Feb 17;14:73. doi: 10.1186/1471-2393-14-73.
PubMed 24533878Bresnahan BW, Vodicka E, Babigumira JB, Malik AM, Yego F, Lokangaka A, Chitah BM, Bauer Z, Chavez H, Moore JL, Garrison LP, Swanson JO, Swanson D, McClure EM, Goldenberg RL, Esamai F, Garces AL, Chomba E, Saleem S, Tshefu A, Bose CL, Bauserman M, Carlo W, Bucher S, Liechty EA, Nathan RO. Cost estimation alongside a multi-regional, multi-country randomized trial of antenatal ultrasound in five low-and-middle-income countries. BMC Public Health. 2021 May 20;21(1):952. doi: 10.1186/s12889-021-10750-8.
PubMed 34016085Figueroa L, McClure EM, Swanson J, Nathan R, Garces AL, Moore JL, Krebs NF, Hambidge KM, Bauserman M, Lokangaka A, Tshefu A, Mirza W, Saleem S, Naqvi F, Carlo WA, Chomba E, Liechty EA, Esamai F, Swanson D, Bose CL, Goldenberg RL. Oligohydramnios: a prospective study of fetal, neonatal and maternal outcomes in low-middle income countries. Reprod Health. 2020 Jan 30;17(1):19. doi: 10.1186/s12978-020-0854-y.
PubMed 32000798Bauserman M, Nathan R, Lokangaka A, McClure EM, Moore J, Ishoso D, Tshefu A, Figueroa L, Garces A, Harrison MS, Wallace D, Saleem S, Mirza W, Krebs N, Hambidge M, Carlo W, Chomba E, Miodovnik M, Koso-Thomas M, Liechty EA, Esamai F, Swanson J, Swanson D, Goldenberg RL, Bose C. Polyhydramnios among women in a cluster-randomized trial of ultrasound during prenatal care within five low and low-middle income countries: a secondary analysis of the first look study. BMC Pregnancy Childbirth. 2019 Jul 22;19(1):258. doi: 10.1186/s12884-019-2412-6.
PubMed 31331296Franklin HL, Mirza W, Swanson DL, Newman JE, Goldenberg RL, Muyodi D, Figueroa L, Nathan RO, Swanson JO, Goldsmith N, Kanaiza N, Naqvi F, Pineda IS, Lopez-Gomez W, Hamsumonde D, Bolamba VL, Fogleman EV, Saleem S, Esamai F, Liechty EA, Garces AL, Krebs NF, Michael Hambidge K, Chomba E, Mwenechanya M, Carlo WA, Tshefu A, Lokangaka A, Bose CL, Koso-Thomas M, Miodovnik M, McClure EM. Factors influencing referrals for ultrasound-diagnosed complications during prenatal care in five low and middle income countries. Reprod Health. 2018 Dec 12;15(1):204. doi: 10.1186/s12978-018-0647-8.
PubMed 30541560
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Network First Look: A Cluster-Randomized Trial of Ultrasound Use to Improve Pregnancy Outcomes in Low Income Country Settings
- ClinicalTrials.gov ID
- NCT01990625
- Acronym / sponsor ID
- GN First Look Ultrasound
- Conditions
- Pregnancy, Eclampsia, Placenta Previa, Stillbirth, Fetal Growth Restriction
- Keywords
- Maternal Near Miss Morbidity, Maternal Mortality, Neonatal Mortality, Gestational Age Dating, Pregnancy Complications, Ultrasound, Stillbirth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45,038 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Bill and Melinda Gates Foundation, GE Healthcare
- Study start
- Apr 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 21 Nov 2013 (estimated)
- 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.
In many low-income countries, the use of ultrasound by medical officers and non-physician health care staff (e.g., midwives) for antenatal identification of high risk pregnancies is a new intervention requiring authoritative investigation. The primary hypothesis to be assessed in this study is that antenatal ultrasound screenings performed by medical officers and non-physician health care staff will significantly reduce a composite outcome consisting of maternal mortality and maternal near miss, stillbirth and neonatal mortality in low-resource settings. Underpinning this hypothesis are two assumptions. The first assumption is that antenatal detection of complicated pregnancies will lead to appropriate referral at the right time for complicated pregnancies to comprehensive emergency obstetric and neonatal care (EmONC) facilities. The second assumption is that ultrasound's introduction will increase antenatal attendance leading to greater rates of institutional delivery. To assess these underlying assumptions beyond the composite end point, this study will investigate the health system impact of compact ultrasound. Secondary outcomes include antenatal attendance rates, institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC facilities, cesarean section rates (both planned and emergent) and an assessment of medical officers and non-physician health care provider ultrasound competence and training quality.
Detailed description
The use of ultrasound by physician and non-physician health care staff for antenatal identification of complicated pregnancies is a potentially effective intervention; however, authoritative investigation in many low-resource settings is needed to establish its potential impact. The investigators propose to undertake a multi-country, cluster randomized trial to assess the impact of antenatal ultrasound screening performed by community physician and non-physician health care staff on a composite outcome consisting of maternal mortality and near miss maternal mortality, stillbirth and neonatal mortality in low-resource settings. Underpinning this objective are several assumptions. The first assumption is that ultrasound's introduction will increase antenatal attendance and improved outcomes due to the antenatal care alone, and greater rates of institutional delivery. The second assumption is that ultrasound use will lead to antenatal detection of complicated pregnancies and timely and appropriate referral for complicated pregnancies to comprehensive emergency obstetric and neonatal care (EmONC) facilities. Increases in antenatal care utilization and referral will result in a decrease in a composite outcome including maternal mortality and near miss mortality, stillbirth and neonatal death. Secondary outcomes to be evaluated include antenatal attendance rates, institutional delivery rates at basic EmONC facilities, referral rates to comprehensive EmONC facilities, cesarean section rates (both planned and emergent), an assessment of community physician and non-physician health care provider ultrasound training and competence and the cost-effectiveness of ultrasound in community health facilities. The investigators will also determine causes for non-compliance with recommendations for referral.
In summary, this trial will evaluate whether training antenatal health care providers to perform basic obstetric ultrasonography, and using these trainees to provide routine ultrasounds in primary care clinics and to refer appropriately will improve pregnancy outcomes in low-resource settings.
To assess the impact of ultrasound, the investigators propose to utilize an existing research infrastructure, the Global Network for Women's and Children's Health Research (Global Network), which currently includes 7 sites in 6 countries, India (2), Pakistan, Kenya, Zambia, DRC and Guatemala. The investigators of the Global Network have an ongoing maternal and newborn health registry to document all pregnancies and their outcomes to 6 weeks post-delivery in more than 100 communities. Thus, population-based rates of maternal mortality and morbidity, stillbirth, and neonatal mortality and morbidity, as well as health care utilization, are being obtained. A sub-set of these clusters will be utilized for the ultrasound trial.
RTI International serves as the data coordinating center for the Global Network to help facilitate the design and conduct of the trial, manage the trial related data, and provide statistical analyses of the trial results. GE Healthcare will provide the ultrasound equipment, and will also fund the University of Washington to provide training and technical support on the implementation of ultrasound in community settings. Together, the Global Network with the support of the University of Washington and GE Healthcare will maximize the resources necessary to conduct a definitive trial on the potential impact of ultrasound to reduce maternal and newborn mortality and maternal morbidity in low-resource settings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound scan | Experimental | Device: Antenatal Ultrasound ScanThe group is pregnant women who reside in an intervention cluster who receive at least one antenatal ultrasound scan during antenatal care during the study time period. |
| Routine antenatal care | No intervention | –The group is pregnant women that reside in the control clusters during the study time period. The group received routine antenatal care. |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pregnant women who provide consent
- Resident of study cluster
- Enrolled/eligible for the Global Network Maternal and Neonatal Health Registry
- Women >16 weeks gestation at enrollment
Key exclusion criteria (1 listed)
- Women who are in labor at time of consent
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 |
|---|---|---|
| Antenatal Ultrasound ScanWomen in the intervention arm will be provided two ultrasound scans to screen for pregnancy complications. | Device | Ultrasound scan |
Primary outcome
Composite outcome
Time frame: Up to 30 months
Introduction of ultrasound will decrease the composite outcome of maternal mortality and near miss maternal mortality events and stillbirths plus early neonatal mortality.
1 secondary outcome
Rate of Women with Complicated Deliveries at Health Facilities
Time frame: Up to 30 months
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 29 Sep 2016.
- Background: PubMed 25415862Nathan R, Swanson JO, Marks W, Goldsmith N, Vance C, Sserwanga NB, Swanson D, McClure EM, Franklin H, Mirza W, Mwenechanya M, Muyodi D, Figuero L, Bolamba VL, Goldenberg RL, Pineda IS. Screening obstetric ultrasound training for a 5-country cluster randomized controlled trial. Ultrasound Q. 2014 Dec;30(4):262-6. doi: 10.1097/RUQ.0000000000000096.
- Background: PubMed 24533878McClure EM, Nathan RO, Saleem S, Esamai F, Garces A, Chomba E, Tshefu A, Swanson D, Mabeya H, Figuero L, Mirza W, Muyodi D, Franklin H, Lokangaka A, Bidashimwa D, Pasha O, Mwenechanya M, Bose CL, Carlo WA, Hambidge KM, Liechty EA, Krebs N, Wallace DD, Swanson J, Koso-Thomas M, Widmer R, Goldenberg RL. First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings. BMC Pregnancy Childbirth. 2014 Feb 17;14:73. doi: 10.1186/1471-2393-14-73.
- Derived from this study: PubMed 34016085Bresnahan BW, Vodicka E, Babigumira JB, Malik AM, Yego F, Lokangaka A, Chitah BM, Bauer Z, Chavez H, Moore JL, Garrison LP, Swanson JO, Swanson D, McClure EM, Goldenberg RL, Esamai F, Garces AL, Chomba E, Saleem S, Tshefu A, Bose CL, Bauserman M, Carlo W, Bucher S, Liechty EA, Nathan RO. Cost estimation alongside a multi-regional, multi-country randomized trial of antenatal ultrasound in five low-and-middle-income countries. BMC Public Health. 2021 May 20;21(1):952. doi: 10.1186/s12889-021-10750-8.
- Derived from this study: PubMed 32000798Figueroa L, McClure EM, Swanson J, Nathan R, Garces AL, Moore JL, Krebs NF, Hambidge KM, Bauserman M, Lokangaka A, Tshefu A, Mirza W, Saleem S, Naqvi F, Carlo WA, Chomba E, Liechty EA, Esamai F, Swanson D, Bose CL, Goldenberg RL. Oligohydramnios: a prospective study of fetal, neonatal and maternal outcomes in low-middle income countries. Reprod Health. 2020 Jan 30;17(1):19. doi: 10.1186/s12978-020-0854-y.
- Derived from this study: PubMed 31331296Bauserman M, Nathan R, Lokangaka A, McClure EM, Moore J, Ishoso D, Tshefu A, Figueroa L, Garces A, Harrison MS, Wallace D, Saleem S, Mirza W, Krebs N, Hambidge M, Carlo W, Chomba E, Miodovnik M, Koso-Thomas M, Liechty EA, Esamai F, Swanson J, Swanson D, Goldenberg RL, Bose C. Polyhydramnios among women in a cluster-randomized trial of ultrasound during prenatal care within five low and low-middle income countries: a secondary analysis of the first look study. BMC Pregnancy Childbirth. 2019 Jul 22;19(1):258. doi: 10.1186/s12884-019-2412-6.
- Derived from this study: PubMed 30541560Franklin HL, Mirza W, Swanson DL, Newman JE, Goldenberg RL, Muyodi D, Figueroa L, Nathan RO, Swanson JO, Goldsmith N, Kanaiza N, Naqvi F, Pineda IS, Lopez-Gomez W, Hamsumonde D, Bolamba VL, Fogleman EV, Saleem S, Esamai F, Liechty EA, Garces AL, Krebs NF, Michael Hambidge K, Chomba E, Mwenechanya M, Carlo WA, Tshefu A, Lokangaka A, Bose CL, Koso-Thomas M, Miodovnik M, McClure EM. Factors influencing referrals for ultrasound-diagnosed complications during prenatal care in five low and middle income countries. Reprod Health. 2018 Dec 12;15(1):204. doi: 10.1186/s12978-018-0647-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal Ultrasound Scan in people with Pregnancy and Eclampsia, run by NICHD Global Network for Women's and Children's Health at 5 sites in 5 countries.
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 1 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 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Guatemala, Kenya, Pakistan, Republic of the Congo, Zambia. 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?
Composite outcome (time frame: Up to 30 months). 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 NCT01990625, which also lists 6 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 29 Sep 2016.