Post Partum HaemorrhagePhase 3IMoxNCT02216383
Intramuscular Oxytocics: A Randomised Control Trial
A Phase 3 study testing Carbetocin, Syntocinon and Syntometrine in people with Post Partum Haemorrhage, run by North Bristol NHS Trust at 5 sites in United Kingdom.
Trial summary
A quarter of all pregnancy and child-birth related deaths are due to excessive bleeding after the birth, "post-partum haemorrhage" (PPH). In the UK, PPH affects approx 10% of new mothers. PPH can be frightening for women and cause them to need additional treatments prolonging their hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Haemorrhage
- What is being tested?
- Carbetocin, Syntocinon and Syntometrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,798 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Feb 2015to 30 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age at time of delivery
- Singleton pregnancy
- Vaginal birth (spontaneous and instrumental)
- >24 weeks gestation
Who cannot join
- Significant APH (>50ml) or suspected or proven placenta abruption
- Maternal coagulation disorder
- Intrauterine fetal death
- Patients who would decline blood products if required
- Known or suspected hypertensive disorders, including pre-eclampsia, pregnancy induced hypertension, essential hypertension (even if blood pressure well controlled)
- Hypertension in labour, or patients who have not had their blood pressure checked in labour
Show all 9Show fewer
- Patients with peripheral, hepatic or cardiac disease
- Patients with an allergy or hypersensitivity to any of the active ingredients in Carbetocin, Syntometrine or Syntocinon
- Epilepsy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Royal United Hospital NHS Trust
Bath, Somerset, BA1 3NG
North Bristol NHS Trust
Bristol, Avon, BS10 5NB
Gloucestershire Hospitals NHS Trust
Gloucester, Gloucestershire, GL1 3NN
Nottingham University Hospitals NHS Trust
Nottingham
Great Western Hospital
Swindon, SN3 6BB
About this study
Official title: Intramuscular Oxytocics: A Randomised Control Trial of Intramuscular Carbetocin, Syntocinon and Syntometrine for the Third Stage of Labour Following Vaginal Birth
A quarter of all pregnancy and child-birth related deaths are due to excessive bleeding after the birth, "post-partum haemorrhage" (PPH). In the UK, PPH affects approx 10% of new mothers. PPH can be frightening for women and cause them to need additional treatments prolonging their hospital stay.
Commonly PPH is caused by an inadequately contracted womb after childbirth. Giving the mother an injection of "uterotonic" medicine following the birth of their baby can prevent this. It reduces the risk of PPH by 66%.
Read more
In the UK, the two medicines most commonly used are Syntocinon and Syntometrine. Syntometrine is longer acting, but a published review of trials concluded that Syntometrine is no better at preventing severe blood loss. Syntometrine is associated with more side effects including nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases of stroke. All guidelines therefore recommend Syntocinon for preventing PPH.Following a telephone survey of all maternity units in the UK, 71.4% of units still routinely use Syntometrine.
Carbetocin is a newer medicine, already widely used after caesarean section, but not yet after vaginal birth. Other studies have shown that Carbetocin is slightly better at preventing bleeding after birth when compared to Syntometrine, has fewer side effects than Syntometrine, and that it may be just as good as Syntocinon at preventing PPH. No studies have directly compared all three medicines or compared their overall cost; information vital to the NHS.
Investigators propose a trial of 5712 women over 13 months, in four maternity units to compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin, for women having a vaginal birth.
Women will be randomly allocated to receive one of these drugs. Women and staff will not know which drug they receive. Staff will collect data such as the number of extra drugs and treatments needed and the volume of blood lost. Women will be asked to complete a side effects questionnaire. Investigators will perform an analysis of cost effectiveness once all results are available.
Aim: To directly compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin given intramuscularly to prevent PPH in the 3rd stage of labour.
Read the detailed description
BACKGROUND Around a quarter of all global pregnancy and child-birth related deaths are due to excessive bleeding after the birth of the baby and placenta, or "post-partum haemorrhage" (PPH). In the UK, PPH affects approximately 10% of new mothers. PPH can be extremely frightening for women and can cause them to need additional treatments including blood transfusion and removal of the womb as well as prolonging their hospital stay.
The most common cause of PPH is an inadequately contracted womb after childbirth. Giving the mother an injection of "uterotonic" medicine following the birth of their baby can prevent this. It reduces the risk of PPH by 66% and this should routinely be offered to all labouring women.
In the UK, the two medicines most commonly used for this purpose are Syntocinon and Syntometrine. Both mimic natural hormones. Syntometrine is longer acting, but a published review of trials comparing these two medicines concluded that Syntometrine is no better at preventing severe blood loss. Syntometrine is associated with more side effects including nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases of stroke. All guidelines therefore recommend Syntocinon for preventing PPH.
Our group conducted a telephone survey of all maternity units in the UK, and found that 71.4% of units still routinely use Syntometrine. Investigators estimate that 40,000-70,000 women per year are experiencing distressing nausea and vomiting in the emotionally important first few hours following childbirth. These women are also receiving a medicine with the potential to cause dangerous high blood pressure.
Carbetocin is a newer medicine, already widely used after caesarean section, but not yet after vaginal birth. Other studies have shown that Carbetocin is slightly better at preventing bleeding after birth when compared to Syntometrine, that it has fewer side effects than Syntometrine, and that it may be just as good as Syntocinon at preventing PPH. No studies have directly compared all three medicines or compared their overall cost; information vital to the NHS.
METHOD Investigators propose a trial of 5712 women over 13 months, in four maternity units in the South-West to compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin, for women having a vaginal birth.
Women will be randomly allocated to receive one of these drugs. Women and staff will not know which drug they receive, so as not to influence the results collected. Staff will collect data such as the number of extra drugs and treatments needed and the volume of blood lost. Women will be asked to complete a side effects questionnaire. Investigators will perform an analysis of cost effectiveness once all results are available.
AIMS To directly compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin given intramuscularly to prevent PPH in the 3rd stage of labour.
- Conditions
- Post Partum Haemorrhage
- Being tested
- Carbetocin, Syntocinon, Syntometrine
- Keywords
- Post partum haemorrhage, Active Management of Third Stage of Labour, Carbetocin, Syntocinon, Syntometrine, Birth experience, Labour
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Pabal
The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Carbetocin, listed here, is one of the of the three study drugs.
SyntocinonDrug
Also called Oxytocin
The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Syntocinon, listed here, is one of the of the three study drugs.
SyntometrineDrug
Also called Syntometrine 500 micrograms/5 IU Solution for Injection
The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Syntometrine, listed here, is one of the of the three study drugs.
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin | Experimental | One dose of 100 micrograms intramuscular Carbetocin given for active management of the third stage of labour, immediately after the birth of the baby Receives: Drug: Carbetocin |
| Syntocinon | Active comparator | One dose of 10 International Units intramuscular Syntocinon given for active management of the third stage of labour, immediately after the birth of the baby Receives: Drug: Syntocinon |
| Syntometrine | Active comparator | One dose of 500micrograms/5 International Units intramuscular Syntometrine given for active management of the third stage of labour, immediately after the birth of the baby Receives: Drug: Syntometrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement for additional uterotonic drugs within 24 hours of birth
Proportion of patients requiring additional uterotonic drugs after administration of study drug
Measured: From administration of prophylactic uterotonic agent to discharge from labour ward, within an expected average of 6 hours.
Secondary outcomes (12)
Estimated volume of blood loss at delivery
Estimated volume of blood loss at delivery
Measured: Within 24 hours of delivery
Transfusion of blood products (type and number of units given)
Number of units of blood transfused, or volume of own blood returned to patient if intraoperative cell salvage used
Measured: From delivery until transfer from Labour Ward, within an expected average of 6 hours.
Manual removal of placenta in theatre
The requirement for the placenta to be removed in theatre
Measured: From delivery until transfer from Labour Ward
Requirement for surgical intervention to manage PPH
As a result of significant PPH a surgical intervention was required to manage the PPH
Measured: From delivery until transfer from Labour Ward, within an expected average of 2 days
Maternal hypertension
Hypertension
Measured: First two postnatal hours following administration of study drug
Maternal hypotension
BP <90/60
Measured: In first two postnatal hours
Maternally-reported health-related quality of life
health-related quality of life reported by mother
Measured: 24 hours after delivery and 14 days after delivery
Abdominal pain in the first two postnatal hours, recorded in Case Report Form (CRF) by midwife
Patient reported secondary outcome
Measured: First 2 post natal hours
Post-partum vomiting
Patient reported secondary outcome
Measured: First 2 post natal hours
Need for anti-emetic
Patient reported secondary outcome
By definition, labour starts when the patient is at least 3-4cm dilated with regular, painful contractions.
Measured: First 2 post natal hours
Headache
Patient reported secondary outcome
Measured: First two post natal hours
Maternal experience of side effects
Captured using maternal side effects questionnaire
Measured: In first two post natal hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startFeb 2015
- Primary completion31 Aug 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Partum HaemorrhageStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,798 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Bristol NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals, University of Bristol, University of the West of England, Royal United Hospital Bath NHS Trust, Gloucestershire Hospitals NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Tim Draycott, BMBS, Study director, North Bristol NHS Trust/University of BristolHelen van der Nelson, BMBS, Study chair, North Bristol NHS Trust/University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216383
- Sponsor's protocol ID
- 3344
- Other IDs
- 2014-001948-37, 2014
- Acronym
- IMox
- Status last verified
- Aug 2018
- First submitted
- 25 Jul 2014
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Nelson H, O'Brien S, Lenguerrand E, Marques E, Alvarez M, Mayer M, Burnard S, Siassakos D, Draycott T. Intramuscular oxytocin versus oxytocin/ergometrine versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: study protocol for a randomised controlled trial (the IMox study). Trials. 2019 Jan 3;20(1):4. doi: 10.1186/s13063-018-3109-2.
PubMed 30606246
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intramuscular Oxytocics: A Randomised Control Trial of Intramuscular Carbetocin, Syntocinon and Syntometrine for the Third Stage of Labour Following Vaginal Birth
- ClinicalTrials.gov ID
- NCT02216383
- Acronym / sponsor ID
- IMox / 3344
- Conditions
- Post Partum Haemorrhage
- Keywords
- Post partum haemorrhage, Active Management of Third Stage of Labour, Carbetocin, Syntocinon, Syntometrine, Birth experience, Labour
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,798 participants (actual)
- Lead sponsor
- North Bristol NHS TrustUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals, University of Bristol, University of the West of England, Royal United Hospital Bath NHS Trust, Gloucestershire Hospitals NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust
- Study start
- Feb 2015
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 15 Aug 2014 (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.
A quarter of all pregnancy and child-birth related deaths are due to excessive bleeding after the birth, "post-partum haemorrhage" (PPH). In the UK, PPH affects approx 10% of new mothers. PPH can be frightening for women and cause them to need additional treatments prolonging their hospital stay.
Commonly PPH is caused by an inadequately contracted womb after childbirth. Giving the mother an injection of "uterotonic" medicine following the birth of their baby can prevent this. It reduces the risk of PPH by 66%.
In the UK, the two medicines most commonly used are Syntocinon and Syntometrine. Syntometrine is longer acting, but a published review of trials concluded that Syntometrine is no better at preventing severe blood loss. Syntometrine is associated with more side effects including nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases of stroke. All guidelines therefore recommend Syntocinon for preventing PPH.Following a telephone survey of all maternity units in the UK, 71.4% of units still routinely use Syntometrine.
Carbetocin is a newer medicine, already widely used after caesarean section, but not yet after vaginal birth. Other studies have shown that Carbetocin is slightly better at preventing bleeding after birth when compared to Syntometrine, has fewer side effects than Syntometrine, and that it may be just as good as Syntocinon at preventing PPH. No studies have directly compared all three medicines or compared their overall cost; information vital to the NHS.
Investigators propose a trial of 5712 women over 13 months, in four maternity units to compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin, for women having a vaginal birth.
Women will be randomly allocated to receive one of these drugs. Women and staff will not know which drug they receive. Staff will collect data such as the number of extra drugs and treatments needed and the volume of blood lost. Women will be asked to complete a side effects questionnaire. Investigators will perform an analysis of cost effectiveness once all results are available.
Aim: To directly compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin given intramuscularly to prevent PPH in the 3rd stage of labour.
Detailed description
BACKGROUND Around a quarter of all global pregnancy and child-birth related deaths are due to excessive bleeding after the birth of the baby and placenta, or "post-partum haemorrhage" (PPH). In the UK, PPH affects approximately 10% of new mothers. PPH can be extremely frightening for women and can cause them to need additional treatments including blood transfusion and removal of the womb as well as prolonging their hospital stay.
The most common cause of PPH is an inadequately contracted womb after childbirth. Giving the mother an injection of "uterotonic" medicine following the birth of their baby can prevent this. It reduces the risk of PPH by 66% and this should routinely be offered to all labouring women.
In the UK, the two medicines most commonly used for this purpose are Syntocinon and Syntometrine. Both mimic natural hormones. Syntometrine is longer acting, but a published review of trials comparing these two medicines concluded that Syntometrine is no better at preventing severe blood loss. Syntometrine is associated with more side effects including nausea, vomiting, and high blood pressure, and has been linked with rare, but fatal, cases of stroke. All guidelines therefore recommend Syntocinon for preventing PPH.
Our group conducted a telephone survey of all maternity units in the UK, and found that 71.4% of units still routinely use Syntometrine. Investigators estimate that 40,000-70,000 women per year are experiencing distressing nausea and vomiting in the emotionally important first few hours following childbirth. These women are also receiving a medicine with the potential to cause dangerous high blood pressure.
Carbetocin is a newer medicine, already widely used after caesarean section, but not yet after vaginal birth. Other studies have shown that Carbetocin is slightly better at preventing bleeding after birth when compared to Syntometrine, that it has fewer side effects than Syntometrine, and that it may be just as good as Syntocinon at preventing PPH. No studies have directly compared all three medicines or compared their overall cost; information vital to the NHS.
METHOD Investigators propose a trial of 5712 women over 13 months, in four maternity units in the South-West to compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin, for women having a vaginal birth.
Women will be randomly allocated to receive one of these drugs. Women and staff will not know which drug they receive, so as not to influence the results collected. Staff will collect data such as the number of extra drugs and treatments needed and the volume of blood lost. Women will be asked to complete a side effects questionnaire. Investigators will perform an analysis of cost effectiveness once all results are available.
AIMS To directly compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin given intramuscularly to prevent PPH in the 3rd stage of labour.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Carbetocin | Experimental | Drug: CarbetocinOne dose of 100 micrograms intramuscular Carbetocin given for active management of the third stage of labour, immediately after the birth of the baby |
| Syntocinon | Active comparator | Drug: SyntocinonOne dose of 10 International Units intramuscular Syntocinon given for active management of the third stage of labour, immediately after the birth of the baby |
| Syntometrine | Active comparator | Drug: SyntometrineOne dose of 500micrograms/5 International Units intramuscular Syntometrine given for active management of the third stage of labour, immediately after the birth of the baby |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age at time of delivery
- Singleton pregnancy
- Vaginal birth (spontaneous and instrumental)
- >24 weeks gestation
Key exclusion criteria (9 listed)
- Significant APH (>50ml) or suspected or proven placenta abruption
- Maternal coagulation disorder
- Intrauterine fetal death
- Patients who would decline blood products if required
- Known or suspected hypertensive disorders, including pre-eclampsia, pregnancy induced hypertension, essential hypertension (even if blood pressure well controlled)
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 |
|---|---|---|
| CarbetocinAlso: PabalThe intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Carbetocin, listed here, is one of the of the three study drugs. | Drug | Carbetocin |
| SyntocinonAlso: OxytocinThe intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Syntocinon, listed here, is one of the of the three study drugs. | Drug | Syntocinon |
| SyntometrineAlso: Syntometrine 500 micrograms/5 IU Solution for InjectionThe intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Syntometrine, listed here, is one of the of the three study drugs. | Drug | Syntometrine |
Primary outcome
Requirement for additional uterotonic drugs within 24 hours of birth
Time frame: From administration of prophylactic uterotonic agent to discharge from labour ward, within an expected average of 6 hours.
Proportion of patients requiring additional uterotonic drugs after administration of study drug
12 secondary outcomes
Estimated volume of blood loss at delivery
Time frame: Within 24 hours of delivery
Transfusion of blood products (type and number of units given)
Time frame: From delivery until transfer from Labour Ward, within an expected average of 6 hours.
Manual removal of placenta in theatre
Time frame: From delivery until transfer from Labour Ward
Requirement for surgical intervention to manage PPH
Time frame: From delivery until transfer from Labour Ward, within an expected average of 2 days
Maternal hypertension
Time frame: First two postnatal hours following administration of study drug
Maternal hypotension
Time frame: In first two postnatal hours
Maternally-reported health-related quality of life
Time frame: 24 hours after delivery and 14 days after delivery
Abdominal pain in the first two postnatal hours, recorded in Case Report Form (CRF) by midwife
Time frame: First 2 post natal hours
Post-partum vomiting
Time frame: First 2 post natal hours
Need for anti-emetic
Time frame: First 2 post natal hours
Headache
Time frame: First two post natal hours
Maternal experience of side effects
Time frame: In first two post natal 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 14 Nov 2018.
- Derived from this study: PubMed 30606246van der Nelson H, O'Brien S, Lenguerrand E, Marques E, Alvarez M, Mayer M, Burnard S, Siassakos D, Draycott T. Intramuscular oxytocin versus oxytocin/ergometrine versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: study protocol for a randomised controlled trial (the IMox study). Trials. 2019 Jan 3;20(1):4. doi: 10.1186/s13063-018-3109-2.
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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.
Tim Draycott, BMBS study director
North Bristol NHS Trust/University of Bristol
Helen van der Nelson, BMBS study chair
North Bristol NHS Trust/University of Bristol
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carbetocin, Syntocinon and Syntometrine in people with Post Partum Haemorrhage, run by North Bristol NHS Trust at 5 sites in United Kingdom.
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 9 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 14 Nov 2018. 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 United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Requirement for additional uterotonic drugs within 24 hours of birth (time frame: From administration of prophylactic uterotonic agent to discharge from labour ward, within an expected average of 6 hours.). 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 NCT02216383, which also lists 1 linked publication.
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 14 Nov 2018.