First Child Delivery With EpiduralPhase 2NCT02705872
Comparison of Two Methods of Administration of the Epidural, by Programmed Intermittent Bolus or Continuous Perfusion, on the Incidence of Cesarean Sections and Instrumented Deliveries in Primiparous Women
A Phase 2 study testing Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml/h and Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml each 60 minutes in people with First Child Delivery With Epidural, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
The epidural has been recognized for many years as the most effective analgesia method for obstetrical labor. Several different administration protocols have been evaluated over the years with the aim of reducing side effects. Epidurals have been incriminated in the increase of instrumented births. 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
- First Child Delivery With Epidural
- What is being tested?
- Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml/h and Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml each 60 minutes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Mar 2016to 20 Mar 2018
- Phase
- Phase 2
- 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
- Women over 18 years of age
- Primiparous
- Pregnancy over 36 weeks of gestational age and <42 weeks of gestational age
- Written informed consent
- Cervical dilatation between 3 and 6 cm at recruitment
- Single pregnancy
- Foetus in cephalic position
Who cannot join
- Participation refusal or epidural contra-indication
- Multiparous
- Allergy to the products used
- Twin pregnancy
- Height <1m55 and/or narrow pelvis, as shown by imagery
- Language barrier
Show all 10Show fewer
- Patients with a BMI superior or equal to 35 (computed with the weight at the beginning of the pregnancy)
- Cervical dilatation at recruitment <3 or >6 cm
- ASA score (American Society of Anesthesiologists) 3 or 4
- Foetus in transverse or seat position
Trial locations and contacts
1 site in 1 country.
About this study
The epidural has been recognized for many years as the most effective analgesia method for obstetrical labor. Several different administration protocols have been evaluated over the years with the aim of reducing side effects.
Epidurals have been incriminated in the increase of instrumented births. It is indeed possible that the motor block induced by the epidural reduces the pelvic tonus and the ability of the mother to push during the second stage of the labor. Furthermore, this motor block might lead to a ill rotation of the foetal head within the pelvis, which could lead to instrumentation (suction cups, forceps).
Read more
In the investigator's institution, an ongoing study also provided interim that showed that the use of a low concentration of local anesthetics (as opposed to a higher concentration) tends to decrease the instrumentation and cesarean sections rate in the institution's population.However, the optimal administration mode of the local anesthetic in the epidural remains unknown.
In the last few years, there has been a growing interest for a new method of administration of the solution within the epidural, by programmed intermittent bolus. This method allows a better distribution of the local anesthetics in the epidural space, compared to a continuous perfusion.
This study therefore focuses on the relationship between the use of epidural with programmed intermittent boluses and the rate of instrumented deliveries and cesarean sections.
The exact mode of administration of boluses is also subject to discussion in the literature. One can question whether it is preferable to administer smaller boluses more frequently or larger less frequent boluses. A few studies have investigated this issue and recommend to administer larger and more spaced bolus (10 mL to 60 minutes).This better matches the sought after physiology (ie a wider distribution in the epidural space) and provides equivalent analgesia to smaller, more frequent boluses.
Read the detailed description
The epidural has been recognized for many years as the most effective analgesia method for obstetrical labor. Several different administration protocols have been evaluated over the years with the aim of reducing side effects.
Epidurals have been incriminated in the increase of instrumented births. It is indeed possible that the motor block induced by the epidural reduces the pelvic tonus and the ability of the mother to push during the second stage of the labor. Furthermore, this motor block might lead to a ill rotation of the foetal head within the pelvis, which could lead to instrumentation (suction cups, forceps).
In 2001, the COMET study showed that the use of low anesthetics concentrations decreases the motor bloc and allows to increase the rate of vaginal deliveries and decrease the rate of instrumented births.
In the investigator's institution, an ongoing study also provided interim that showed that the use of a low concentration of local anesthetics (as opposed to a higher concentration) tends to decrease the instrumentation and cesarean sections rate in the institution's population.
However, the optimal administration mode of the local anesthetic in the epidural remains unknown.
In the last few years, there has been a growing interest for a new method of administration of the solution within the epidural, by programmed intermittent bolus. This method allows a better distribution of the local anesthetics in the epidural space, compared to a continuous perfusion.
Several studies have been performed and show that this mode of administration allows to decrease the local anesthetics injected dosis and gives a better maternal satisfaction. A meta-analysis performed in 2013 also shows a tendency towards the decrease of instrumented deliveries with this method. Sadly, no studies up to this date have the needed power to prove this point with certainty.
This study therefore focuses on the relationship between the use of epidural with programmed intermittent boluses and the rate of instrumented deliveries and cesarean sections.
The exact mode of administration of boluses is also subject to discussion in the literature. One can question whether it is preferable to administer smaller boluses more frequently or larger less frequent boluses. A few studies have investigated this issue and recommend to administer larger and more spaced bolus (10 mL to 60 minutes).This better matches the sought after physiology (ie a wider distribution in the epidural space) and provides equivalent analgesia to smaller, more frequent boluses.
- Conditions
- First Child Delivery With Epidural
- Being tested
- Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml/h, Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml each 60 minutes
- Keywords
- Epidural, Programmed intermittent boluses, Cesarian section, Instrumented delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml/hDrug
Continuous epidural perfusion: Chirocaine 0.07% + Sufentanil 0.3 mcg/ml with a 10ml/hour rate
Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml each 60 minutesDrug
Injection of programmed intermittent boluses in the epidural space, without continuous perfusion, of the same solution (Chirocaine 0.07% + Sufentanil 0.3 mcg/ml): 10ml each 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Programmed intermittent boluses | Experimental | Epidural analgesia performed with programmed intermittent boluses. Receives: Drug: Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml each 60 minutes |
| Continuous perfusion | Active comparator | Epidural analgesia performed with a continuous perfusion. Receives: Drug: Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of instrumented deliveries (suction pumps, forceps)
Number of deliveries requiring instrumentation (suction pumps, forceps)
Measured: 24h after the baby's birth
Rate of cesarian sections
Number of deliveries requiring a cesarian section
Measured: 24h after the baby's birth
Secondary outcomes (3)
Number of anesthesist interventions
Number of visits of the anesthesist, either requested by the patient (request for additional analgesia by the patient because of pain during labor: the pain itself is not measured), either necessary because of side effects (nausea, pruritus).
Measured: Starting from the first injection of the epidural till the baby's birth
Maternal satisfaction
Will be assessed by means of a questionnaire (0 to 100 visual scale)
Measured: 24h after the baby's birth
Presence of a motor block
Assessed by the anesthesist with the Bromage modified scale
Measured: At the precise moment when the cervix reaches complete dilatation (10 cm opening) during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study start8 Mar 2016
- Primary completion20 Mar 2018
- Study completion20 Mar 2018
Why it stopped: Change in guidelines
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for First Child Delivery With EpiduralStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe VAN DER LINDEN, Brugmann University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705872
- Sponsor's protocol ID
- CHUB-PIB
- Status last verified
- May 2018
- First submitted
- 2 Mar 2016
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Howell CJ. Epidural versus non-epidural analgesia for pain relief in labour. Cochrane Database Syst Rev. 2000;(2):CD000331. doi: 10.1002/14651858.CD000331.
PubMed 10796196George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
PubMed 23223119Thorp JA, Hu DH, Albin RM, McNitt J, Meyer BA, Cohen GR, Yeast JD. The effect of intrapartum epidural analgesia on nulliparous labor: a randomized, controlled, prospective trial. Am J Obstet Gynecol. 1993 Oct;169(4):851-8. doi: 10.1016/0002-9378(93)90015-b.
PubMed 8238138Comparative Obstetric Mobile Epidural Trial (COMET) Study Group UK. Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial. Lancet. 2001 Jul 7;358(9275):19-23. doi: 10.1016/S0140-6736(00)05251-X.
PubMed 11454372Kaynar AM, Shankar KB. Epidural infusion: continuous or bolus? Anesth Analg. 1999 Aug;89(2):534. doi: 10.1097/00000539-199908000-00063. No abstract available.
PubMed 10439786Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.
PubMed 16492849Sia AT, Leo S, Ocampo CE. A randomised comparison of variable-frequency automated mandatory boluses with a basal infusion for patient-controlled epidural analgesia during labour and delivery. Anaesthesia. 2013 Mar;68(3):267-75. doi: 10.1111/anae.12093. Epub 2012 Dec 20.
PubMed 23278328Lim Y, Chakravarty S, Ocampo CE, Sia AT. Comparison of automated intermittent low volume bolus with continuous infusion for labour epidural analgesia. Anaesth Intensive Care. 2010 Sep;38(5):894-9. doi: 10.1177/0310057X1003800514.
PubMed 20865875Wong CA, McCarthy RJ, Hewlett B. The effect of manipulation of the programmed intermittent bolus time interval and injection volume on total drug use for labor epidural analgesia: a randomized controlled trial. Anesth Analg. 2011 Apr;112(4):904-11. doi: 10.1213/ANE.0b013e31820e7c2f.
PubMed 21430035Breen TW, Shapiro T, Glass B, Foster-Payne D, Oriol NE. Epidural anesthesia for labor in an ambulatory patient. Anesth Analg. 1993 Nov;77(5):919-24. doi: 10.1213/00000539-199311000-00008.
PubMed 8214727
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods of Administration of the Epidural, by Programmed Intermittent Bolus or Continuous Perfusion, on the Incidence of Cesarean Sections and Instrumented Deliveries in Primiparous Women
- ClinicalTrials.gov ID
- NCT02705872
- Acronym / sponsor ID
- CHUB-PIB
- Conditions
- First Child Delivery With Epidural
- Keywords
- Epidural, Programmed intermittent boluses, Cesarian section, Instrumented delivery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in guidelines
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 11 Mar 2016 (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.
The epidural has been recognized for many years as the most effective analgesia method for obstetrical labor. Several different administration protocols have been evaluated over the years with the aim of reducing side effects.
Epidurals have been incriminated in the increase of instrumented births. It is indeed possible that the motor block induced by the epidural reduces the pelvic tonus and the ability of the mother to push during the second stage of the labor. Furthermore, this motor block might lead to a ill rotation of the foetal head within the pelvis, which could lead to instrumentation (suction cups, forceps).
In the investigator's institution, an ongoing study also provided interim that showed that the use of a low concentration of local anesthetics (as opposed to a higher concentration) tends to decrease the instrumentation and cesarean sections rate in the institution's population.However, the optimal administration mode of the local anesthetic in the epidural remains unknown.
In the last few years, there has been a growing interest for a new method of administration of the solution within the epidural, by programmed intermittent bolus. This method allows a better distribution of the local anesthetics in the epidural space, compared to a continuous perfusion.
This study therefore focuses on the relationship between the use of epidural with programmed intermittent boluses and the rate of instrumented deliveries and cesarean sections.
The exact mode of administration of boluses is also subject to discussion in the literature. One can question whether it is preferable to administer smaller boluses more frequently or larger less frequent boluses. A few studies have investigated this issue and recommend to administer larger and more spaced bolus (10 mL to 60 minutes).This better matches the sought after physiology (ie a wider distribution in the epidural space) and provides equivalent analgesia to smaller, more frequent boluses.
Detailed description
The epidural has been recognized for many years as the most effective analgesia method for obstetrical labor. Several different administration protocols have been evaluated over the years with the aim of reducing side effects.
Epidurals have been incriminated in the increase of instrumented births. It is indeed possible that the motor block induced by the epidural reduces the pelvic tonus and the ability of the mother to push during the second stage of the labor. Furthermore, this motor block might lead to a ill rotation of the foetal head within the pelvis, which could lead to instrumentation (suction cups, forceps).
In 2001, the COMET study showed that the use of low anesthetics concentrations decreases the motor bloc and allows to increase the rate of vaginal deliveries and decrease the rate of instrumented births.
In the investigator's institution, an ongoing study also provided interim that showed that the use of a low concentration of local anesthetics (as opposed to a higher concentration) tends to decrease the instrumentation and cesarean sections rate in the institution's population.
However, the optimal administration mode of the local anesthetic in the epidural remains unknown.
In the last few years, there has been a growing interest for a new method of administration of the solution within the epidural, by programmed intermittent bolus. This method allows a better distribution of the local anesthetics in the epidural space, compared to a continuous perfusion.
Several studies have been performed and show that this mode of administration allows to decrease the local anesthetics injected dosis and gives a better maternal satisfaction. A meta-analysis performed in 2013 also shows a tendency towards the decrease of instrumented deliveries with this method. Sadly, no studies up to this date have the needed power to prove this point with certainty.
This study therefore focuses on the relationship between the use of epidural with programmed intermittent boluses and the rate of instrumented deliveries and cesarean sections.
The exact mode of administration of boluses is also subject to discussion in the literature. One can question whether it is preferable to administer smaller boluses more frequently or larger less frequent boluses. A few studies have investigated this issue and recommend to administer larger and more spaced bolus (10 mL to 60 minutes).This better matches the sought after physiology (ie a wider distribution in the epidural space) and provides equivalent analgesia to smaller, more frequent boluses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Programmed intermittent boluses | Experimental | Drug: Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml each 60 minutesEpidural analgesia performed with programmed intermittent boluses. |
| Continuous perfusion | Active comparator | Drug: Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml/hEpidural analgesia performed with a continuous perfusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women over 18 years of age
- Primiparous
- Pregnancy over 36 weeks of gestational age and <42 weeks of gestational age
- Written informed consent
- Cervical dilatation between 3 and 6 cm at recruitment
Key exclusion criteria (10 listed)
- Participation refusal or epidural contra-indication
- Multiparous
- Allergy to the products used
- Twin pregnancy
- Height <1m55 and/or narrow pelvis, as shown by imagery
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 |
|---|---|---|
| Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml/hContinuous epidural perfusion: Chirocaine 0.07% + Sufentanil 0.3 mcg/ml with a 10ml/hour rate | Drug | Continuous perfusion |
| Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml each 60 minutesInjection of programmed intermittent boluses in the epidural space, without continuous perfusion, of the same solution (Chirocaine 0.07% + Sufentanil 0.3 mcg/ml): 10ml each 60 minutes | Drug | Programmed intermittent boluses |
Primary outcome
Rate of instrumented deliveries (suction pumps, forceps)
Time frame: 24h after the baby's birth
Number of deliveries requiring instrumentation (suction pumps, forceps)
Rate of cesarian sections
Time frame: 24h after the baby's birth
Number of deliveries requiring a cesarian section
3 secondary outcomes
Number of anesthesist interventions
Time frame: Starting from the first injection of the epidural till the baby's birth
Maternal satisfaction
Time frame: 24h after the baby's birth
Presence of a motor block
Time frame: At the precise moment when the cervix reaches complete dilatation (10 cm opening) during labor
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Background: PubMed 10796196Howell CJ. Epidural versus non-epidural analgesia for pain relief in labour. Cochrane Database Syst Rev. 2000;(2):CD000331. doi: 10.1002/14651858.CD000331.
- Background: PubMed 23223119George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
- Background: PubMed 8238138Thorp JA, Hu DH, Albin RM, McNitt J, Meyer BA, Cohen GR, Yeast JD. The effect of intrapartum epidural analgesia on nulliparous labor: a randomized, controlled, prospective trial. Am J Obstet Gynecol. 1993 Oct;169(4):851-8. doi: 10.1016/0002-9378(93)90015-b.
- Background: PubMed 11454372Comparative Obstetric Mobile Epidural Trial (COMET) Study Group UK. Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial. Lancet. 2001 Jul 7;358(9275):19-23. doi: 10.1016/S0140-6736(00)05251-X.
- Background: PubMed 10439786Kaynar AM, Shankar KB. Epidural infusion: continuous or bolus? Anesth Analg. 1999 Aug;89(2):534. doi: 10.1097/00000539-199908000-00063. No abstract available.
- Background: PubMed 16492849Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.
- Background: PubMed 23278328Sia AT, Leo S, Ocampo CE. A randomised comparison of variable-frequency automated mandatory boluses with a basal infusion for patient-controlled epidural analgesia during labour and delivery. Anaesthesia. 2013 Mar;68(3):267-75. doi: 10.1111/anae.12093. Epub 2012 Dec 20.
- Background: PubMed 20865875Lim Y, Chakravarty S, Ocampo CE, Sia AT. Comparison of automated intermittent low volume bolus with continuous infusion for labour epidural analgesia. Anaesth Intensive Care. 2010 Sep;38(5):894-9. doi: 10.1177/0310057X1003800514.
- Background: PubMed 21430035Wong CA, McCarthy RJ, Hewlett B. The effect of manipulation of the programmed intermittent bolus time interval and injection volume on total drug use for labor epidural analgesia: a randomized controlled trial. Anesth Analg. 2011 Apr;112(4):904-11. doi: 10.1213/ANE.0b013e31820e7c2f.
- Background: PubMed 8214727Breen TW, Shapiro T, Glass B, Foster-Payne D, Oriol NE. Epidural anesthesia for labor in an ambulatory patient. Anesth Analg. 1993 Nov;77(5):919-24. doi: 10.1213/00000539-199311000-00008.
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 Phase 2 study testing Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml/h and Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml each 60 minutes in people with First Child Delivery With Epidural, run by Brugmann University Hospital at 1 site in Belgium.
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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 31 May 2018. 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of instrumented deliveries (suction pumps, forceps) (time frame: 24h after the baby's birth). The study lists 2 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 NCT02705872, which also lists 10 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 31 May 2018.