Cesarean SectionPhase 4RIPENCT00383942
Ripening Interventions: Prostaglandins vs EASI Catheter
A Phase 4 study testing Misoprostol and Catheter in people with Cesarean Section, run by Loyola University at 1 site in United States.
Trial summary
The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Misoprostol and Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2006to 18 Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton pregnancy
- Cephalic presentation
- 36 completed weeks of gestation
- Intact membranes
- Unfavorable cervix (defined as Bishop score < 5)
- Indication for induction of labor
- Fetal Station less than or equal to -3
Who cannot join
- Clinically significant vaginal bleeding
- Evidence of spontaneous labor (3 contractions in 10 minutes)
- Contraindication to induction of labor or to use of prostaglandins
- Fetal station higher than -3
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: The RIPE Study: Ripening Interventions: Prostaglandins vs EASI Catheter
The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI catheter are less likely to undergo cesarean section for fetal intolerance of labor when compared to women who receive misoprostol.
Read the detailed description
Induction of labor is a common obstetrical practice. In fact, the rate of induction has risen to 184/1000 live births. It is well known that a favorable Bishop score, defined as Bishop score 5-8, improves the safety and success rate for induction of labor and vaginal delivery. Several methods for cervical ripening, both mechanical and pharmacological, have been developed to improve Bishop score in women eligible for induction of labor with an unfavorable cervix. These methods include: misoprostol, dinoprostone, intracervical catheter with and without extra-amniotic saline infusion, and laminaria.
Several studies have investigated the optimum cervical ripening agent, and review of current literature supports that misoprostol given in a dose of 25 micrograms every 4 hours intravaginally as the most efficacious and inexpensive regimen while maintaining safe maternal and fetal outcomes. Several studies have shown that misoprostol has a significantly shorter time to delivery compared with other methods of ripening. In fact, in a 2003 Cochrane Database Systematic Review, misoprostol was shown to have increased cervical ripening effectiveness and reduced failure to achieve vaginal delivery in 12-24 hours. Further, while uterine hyper-stimulation and tachysystole were more common in the misoprostol groups, no adverse neonatal outcomes were described. However, misoprostol has been shown to have a higher incidence of cesarean section for fetal intolerance to labor compared to other cervical ripening methods including EASI. Several studies support the ideal route of administration and dosage of misoprostol to be 25 micrograms every 4 hours intravaginally. This regimen leads to effective cervical ripening while reducing the dose-dependent effect of misoprostol on uterine tachysystole and hyperstimulation. Another aspect to consider in cervical ripening method is cost. Misoprostol is much less expensive than other methods including dinoprostone. In fact, one article reports that the average cost per patient for misoprostol treatment was $85 compared to $606 for dinoprostone insert.
Extra-amniotic saline infusion (EASI) has been introduced as a mechanical, non-pharmacological cervical ripening method. It involves placement of a Foley catheter through the cervix and is supplemented with continuous extra-amniotic infusion of saline. This is thought to improve prostaglandin release, resulting in shortened duration of labor. Several studies have been performed to determine the safety and efficacy of the EASI method.
Since misoprostol is efficacious, safe, and inexpensive, it is a superior method for cervical ripening and will act as a control for an experimental group undergoing cervical ripening with the EASI catheter. Our hypothesis is that cervical ripening with the EASI method will result in fewer cesarean sections for fetal intolerance to labor as compared to misoprostol. Furthermore, patients undergoing cervical ripening with EASI will experience a shorter time to delivery, have less expense, have fewer adverse effects, and will be more satisfied with EASI catheter than with misoprostol.
- Conditions
- Cesarean Section
- Being tested
- Misoprostol, Catheter
- Keywords
- Pregnancy, Extra amniotic saline infusion, Misoprostol, Labor induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
Misoprostol,25 micrograms every 4 hours.
CatheterDevice
Also called EASI
A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | Patients randomized to this arm will receive 25 micrograms of misoprostol every four hours. Receives: Drug: Misoprostol |
| EASI Catheter | Experimental | Patients randomized to this arm will receive extra amniotic saline infusion (EASI) administered via catheter Receives: Device: Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor
The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study start31 Aug 2006
- Primary completion18 Jun 2008
- Study completion18 Jun 2008
Why it stopped: Change in treatment plan for this population terminated the project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Graziano, Loyola University
- Investigators
- Scott Graziano, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383942
- Sponsor's protocol ID
- 109040
- Acronym
- RIPE
- Status last verified
- Jan 2017
- First submitted
- 2 Oct 2006
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share individual participant data
Publications
Johnson DP, Davis NR, Brown AJ. Risk of cesarean delivery after induction at term in nulliparous women with an unfavorable cervix. Am J Obstet Gynecol. 2003 Jun;188(6):1565-9; discussion 1569-72. doi: 10.1067/mob.2003.458.
PubMed 12824994Afolabi BB, Oyeneyin OL, Ogedengbe OK. Intravaginal misoprostol versus Foley catheter for cervical ripening and induction of labor. Int J Gynaecol Obstet. 2005 Jun;89(3):263-7. doi: 10.1016/j.ijgo.2005.02.010. Epub 2005 Apr 2.
PubMed 15919393Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. doi: 10.1097/01.AOG.0000198629.44186.c8.
PubMed 16449106Sanchez-Ramos L, Peterson DE, Delke I, Gaudier FL, Kaunitz AM. Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: a randomized trial. Obstet Gynecol. 1998 Mar;91(3):401-5. doi: 10.1016/s0029-7844(97)00673-x.
PubMed 9491868Garry D, Figueroa R, Kalish RB, Catalano CJ, Maulik D. Randomized controlled trial of vaginal misoprostol versus dinoprostone vaginal insert for labor induction. J Matern Fetal Neonatal Med. 2003 Apr;13(4):254-9. doi: 10.1080/jmf.13.4.254.259.
PubMed 12854927Adeniji OA, Oladokun A, Olayemi O, Adeniji OI, Odukogbe AA, Ogunbode O, Aimakhu CO, Omigbodun AO, Ilesanmi AO. Pre-induction cervical ripening: transcervical foley catheter versus intravaginal misoprostol. J Obstet Gynaecol. 2005 Feb;25(2):134-9. doi: 10.1080/01443610500040737.
PubMed 15814391Abramovici D, Goldwasser S, Mabie BC, Mercer BM, Goldwasser R, Sibai BM. A randomized comparison of oral misoprostol versus Foley catheter and oxytocin for induction of labor at term. Am J Obstet Gynecol. 1999 Nov;181(5 Pt 1):1108-12. doi: 10.1016/s0002-9378(99)70090-6.
PubMed 10561627Hofmeyr GJ, Gulmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD000941. doi: 10.1002/14651858.CD000941.pub2.
PubMed 20927722le Roux PA, Olarogun JO, Penny J, Anthony J. Oral and vaginal misoprostol compared with dinoprostone for induction of labor: a randomized controlled trial. Obstet Gynecol. 2002 Feb;99(2):201-5. doi: 10.1016/s0029-7844(01)01681-7.
PubMed 11814497Guinn DA, Goepfert AR, Christine M, Owen J, Hauth JC. Extra-amniotic saline, laminaria, or prostaglandin E(2) gel for labor induction with unfavorable cervix: a randomized controlled trial. Obstet Gynecol. 2000 Jul;96(1):106-12. doi: 10.1016/s0029-7844(00)00856-5.
PubMed 10862852Sanchez-Ramos L, Kaunitz AM, Wears RL, Delke I, Gaudier FL. Misoprostol for cervical ripening and labor induction: a meta-analysis. Obstet Gynecol. 1997 Apr;89(4):633-42. doi: 10.1016/S0029-7844(96)00374-2.
PubMed 9083326Meydanli MM, Caliskan E, Burak F, Narin MA, Atmaca R. Labor induction post-term with 25 micrograms vs. 50 micrograms of intravaginal misoprostol. Int J Gynaecol Obstet. 2003 Jun;81(3):249-55. doi: 10.1016/s0020-7292(03)00042-0.
PubMed 12767565Has R, Batukan C, Ermis H, Cevher E, Araman A, Kilic G, Ibrahimoglu L. Comparison of 25 and 50 microg vaginally administered misoprostol for preinduction of cervical ripening and labor induction. Gynecol Obstet Invest. 2002;53(1):16-21. doi: 10.1159/000049405.
PubMed 11803223Diro M, Adra A, Gilles JM, Nassar A, Rodriguez A, Salamat SM, Beydoun SN, O'Sullivan MJ, Yasin SY, Burkett G. A double-blind randomized trial of two dose regimens of misoprostol for cervical ripening and labor induction. J Matern Fetal Med. 1999 May-Jun;8(3):114-8. doi: 10.1002/(SICI)1520-6661(199905/06)8:33.0.CO;2-5.
PubMed 10338065Sharami SH, Milani F, Zahiri Z, Mansour-Ghanaei F. A randomized trial of prostaglandin E2 gel and extra-amniotic saline infusion with high dose oxytocin for cervical ripening. Med Sci Monit. 2005 Aug;11(8):CR381-6. Epub 2005 Jul 25.
PubMed 16049380
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RIPE Study: Ripening Interventions: Prostaglandins vs EASI Catheter
- ClinicalTrials.gov ID
- NCT00383942
- Acronym / sponsor ID
- RIPE / 109040
- Conditions
- Cesarean Section
- Keywords
- Pregnancy, Extra amniotic saline infusion, Misoprostol, Labor induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in treatment plan for this population terminated the project
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- 31 Aug 2006 (actual)
- Primary completion
- 18 Jun 2008 (actual)
- Study completion
- 18 Jun 2008 (actual)
- First posted
- 4 Oct 2006 (estimated)
- Results
- Posted 13 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI catheter are less likely to undergo cesarean section for fetal intolerance of labor when compared to women who receive misoprostol.
Detailed description
Induction of labor is a common obstetrical practice. In fact, the rate of induction has risen to 184/1000 live births. It is well known that a favorable Bishop score, defined as Bishop score 5-8, improves the safety and success rate for induction of labor and vaginal delivery. Several methods for cervical ripening, both mechanical and pharmacological, have been developed to improve Bishop score in women eligible for induction of labor with an unfavorable cervix. These methods include: misoprostol, dinoprostone, intracervical catheter with and without extra-amniotic saline infusion, and laminaria.
Several studies have investigated the optimum cervical ripening agent, and review of current literature supports that misoprostol given in a dose of 25 micrograms every 4 hours intravaginally as the most efficacious and inexpensive regimen while maintaining safe maternal and fetal outcomes. Several studies have shown that misoprostol has a significantly shorter time to delivery compared with other methods of ripening. In fact, in a 2003 Cochrane Database Systematic Review, misoprostol was shown to have increased cervical ripening effectiveness and reduced failure to achieve vaginal delivery in 12-24 hours. Further, while uterine hyper-stimulation and tachysystole were more common in the misoprostol groups, no adverse neonatal outcomes were described. However, misoprostol has been shown to have a higher incidence of cesarean section for fetal intolerance to labor compared to other cervical ripening methods including EASI. Several studies support the ideal route of administration and dosage of misoprostol to be 25 micrograms every 4 hours intravaginally. This regimen leads to effective cervical ripening while reducing the dose-dependent effect of misoprostol on uterine tachysystole and hyperstimulation. Another aspect to consider in cervical ripening method is cost. Misoprostol is much less expensive than other methods including dinoprostone. In fact, one article reports that the average cost per patient for misoprostol treatment was $85 compared to $606 for dinoprostone insert.
Extra-amniotic saline infusion (EASI) has been introduced as a mechanical, non-pharmacological cervical ripening method. It involves placement of a Foley catheter through the cervix and is supplemented with continuous extra-amniotic infusion of saline. This is thought to improve prostaglandin release, resulting in shortened duration of labor. Several studies have been performed to determine the safety and efficacy of the EASI method.
Since misoprostol is efficacious, safe, and inexpensive, it is a superior method for cervical ripening and will act as a control for an experimental group undergoing cervical ripening with the EASI catheter. Our hypothesis is that cervical ripening with the EASI method will result in fewer cesarean sections for fetal intolerance to labor as compared to misoprostol. Furthermore, patients undergoing cervical ripening with EASI will experience a shorter time to delivery, have less expense, have fewer adverse effects, and will be more satisfied with EASI catheter than with misoprostol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Active comparator | Drug: MisoprostolPatients randomized to this arm will receive 25 micrograms of misoprostol every four hours. |
| EASI Catheter | Experimental | Device: CatheterPatients randomized to this arm will receive extra amniotic saline infusion (EASI) administered via catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Singleton pregnancy
- Cephalic presentation
- 36 completed weeks of gestation
- Intact membranes
- Unfavorable cervix (defined as Bishop score < 5)
Key exclusion criteria (4 listed)
- Clinically significant vaginal bleeding
- Evidence of spontaneous labor (3 contractions in 10 minutes)
- Contraindication to induction of labor or to use of prostaglandins
- Fetal station higher than -3
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 |
|---|---|---|
| MisoprostolAlso: CytotecMisoprostol,25 micrograms every 4 hours. | Drug | Misoprostol |
| CatheterAlso: EASIA catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen | Device | EASI Catheter |
Primary outcome
Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor
Time frame: At time of delivery
The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12824994Johnson DP, Davis NR, Brown AJ. Risk of cesarean delivery after induction at term in nulliparous women with an unfavorable cervix. Am J Obstet Gynecol. 2003 Jun;188(6):1565-9; discussion 1569-72. doi: 10.1067/mob.2003.458.
- Background: PubMed 15919393Afolabi BB, Oyeneyin OL, Ogedengbe OK. Intravaginal misoprostol versus Foley catheter for cervical ripening and induction of labor. Int J Gynaecol Obstet. 2005 Jun;89(3):263-7. doi: 10.1016/j.ijgo.2005.02.010. Epub 2005 Apr 2.
- Background: PubMed 16449106Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. doi: 10.1097/01.AOG.0000198629.44186.c8.
- Background: PubMed 9491868Sanchez-Ramos L, Peterson DE, Delke I, Gaudier FL, Kaunitz AM. Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: a randomized trial. Obstet Gynecol. 1998 Mar;91(3):401-5. doi: 10.1016/s0029-7844(97)00673-x.
- Background: PubMed 12854927Garry D, Figueroa R, Kalish RB, Catalano CJ, Maulik D. Randomized controlled trial of vaginal misoprostol versus dinoprostone vaginal insert for labor induction. J Matern Fetal Neonatal Med. 2003 Apr;13(4):254-9. doi: 10.1080/jmf.13.4.254.259.
- Background: PubMed 15814391Adeniji OA, Oladokun A, Olayemi O, Adeniji OI, Odukogbe AA, Ogunbode O, Aimakhu CO, Omigbodun AO, Ilesanmi AO. Pre-induction cervical ripening: transcervical foley catheter versus intravaginal misoprostol. J Obstet Gynaecol. 2005 Feb;25(2):134-9. doi: 10.1080/01443610500040737.
- Background: PubMed 10561627Abramovici D, Goldwasser S, Mabie BC, Mercer BM, Goldwasser R, Sibai BM. A randomized comparison of oral misoprostol versus Foley catheter and oxytocin for induction of labor at term. Am J Obstet Gynecol. 1999 Nov;181(5 Pt 1):1108-12. doi: 10.1016/s0002-9378(99)70090-6.
- Background: PubMed 20927722Hofmeyr GJ, Gulmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD000941. doi: 10.1002/14651858.CD000941.pub2.
- Background: PubMed 11814497le Roux PA, Olarogun JO, Penny J, Anthony J. Oral and vaginal misoprostol compared with dinoprostone for induction of labor: a randomized controlled trial. Obstet Gynecol. 2002 Feb;99(2):201-5. doi: 10.1016/s0029-7844(01)01681-7.
- Background: PubMed 10862852Guinn DA, Goepfert AR, Christine M, Owen J, Hauth JC. Extra-amniotic saline, laminaria, or prostaglandin E(2) gel for labor induction with unfavorable cervix: a randomized controlled trial. Obstet Gynecol. 2000 Jul;96(1):106-12. doi: 10.1016/s0029-7844(00)00856-5.
- Background: PubMed 9083326Sanchez-Ramos L, Kaunitz AM, Wears RL, Delke I, Gaudier FL. Misoprostol for cervical ripening and labor induction: a meta-analysis. Obstet Gynecol. 1997 Apr;89(4):633-42. doi: 10.1016/S0029-7844(96)00374-2.
- Background: PubMed 12767565Meydanli MM, Caliskan E, Burak F, Narin MA, Atmaca R. Labor induction post-term with 25 micrograms vs. 50 micrograms of intravaginal misoprostol. Int J Gynaecol Obstet. 2003 Jun;81(3):249-55. doi: 10.1016/s0020-7292(03)00042-0.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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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.
Scott Graziano, MD principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol and Catheter in people with Cesarean Section, run by Loyola University at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 13 Mar 2017. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor (time frame: At time of delivery). 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 NCT00383942, which also lists 15 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 13 Mar 2017.