Labor InductionNCT03039036
Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
A study testing Amniotomy, Foley Catheter and Misoprostol in people with Labor Induction, run by Northwestern University at 1 site in United States.
Trial summary
Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Induction
- What is being tested?
- Amniotomy, Foley Catheter and Misoprostol
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2017to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- English speaking
- Women age 18 years old or greater
- Nulliparous
- Pregnant with a singleton gestation that is greater than or equal to 37 weeks
- Undergoing induction of labor with Foley catheter
Who cannot join
- Women not meeting above criteria
- Fetus in non-cephalic position
- Intrauterine fetal demise
- Fetus with major anomalies
- HIV, hepatitis B or C infection
- Planned use of oxytocin during the Foley catheter ripening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least 4 hours after Foley catheter removal). Other aims include the relationship between timing of amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar score <7 at 5 minutes, neonatal need for intensive care.
The investigators hypothesize that induction of labor with Foley catheters followed by early amniotomy will result in a decreased duration of labor compared to those who undergo delayed amniotomy.
Read the detailed description
This randomized clinical trial of consenting nulliparous women undergoing induction of labor with a Foley catheter seeks to determine whether use of early amniotomy (defined as amniotomy within 1 hour of Foley catheter removal) improves obstetrical outcomes when compared with delayed amniotomy (defined as amniotomy at least 4 hours following Foley catheter removal).
This project will include 110 women recruited from the obstetrical service at Prentice Women's Hospital. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter. Following removal of Foley catheter, women will be assessed for safety of amniotomy and if appropriate, randomized to either early amniotomy or delayed amniotomy.
Women will be randomized with equal probability to the intervention group using block randomization stratified by use of Foley catheter alone or Foley catheter-misoprostol use.
Women in the early amniotomy group will undergo amniotomy within 1 hour of Foley catheter removal. Women in the delayed amniotomy group will undergo amniotomy at least 4 hours following Foley removal. The remainder of labor management will be at the discretion of each woman's obstetric provider.
Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
- Conditions
- Labor Induction
- Being tested
- Amniotomy, Foley Catheter, Misoprostol
- Keywords
- Labor Induction, Early Amniotomy, Foley catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmniotomyProcedure or surgery
Artificially rupturing membranes
Foley CatheterDevice
Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline. It is removed when either 1. it falls out under gentile traction during labor checks or 2. it is de-inflated at 12 hours after placement. If at the time of de-inflation at 12 hours, the desired affect has not been achieved, the provider may choose to place another foley balloon or use an alternative method of induction (misoprostol). This is an eligibility criteria and only patients who are undergoing induction with a Foley Catheter will be approached for enrollment.
MisoprostolDrug
Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg. Use of this medication will be decided by the provider.
| Study group | Role | What they receive |
|---|---|---|
| Early Amniotomy | Experimental | Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy within 1 hour of Foley catheter removal. Receives: Procedure: Amniotomy; Device: Foley Catheter; Drug: Misoprostol |
| Delayed Amniotomy | Active comparator | Patients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy no sooner than 4 hours following removal of Foley catheter. Receives: Procedure: Amniotomy; Device: Foley Catheter; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval from Foley catheter removal to delivery
Hours
Measured: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
Secondary outcomes (11)
Cesarean delivery
binary; yes/no
Measured: At time of delivery
Chorioamnionitis
Maternal Temperature of >/= 39 degrees Celsius or >/= 38 degrees Celsius on two occasions greater than 30 minutes apart and at least one of the following: Fetal tachycardia (defined as sustained (>10 min) fetal heart rate >160), White Bood Cell Count >15, purulent fluid from cervical os, or receipt of antibiotics and diagnosis written in the chart
Measured: From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours
Postpartum Fever
Temperature >/= 38 degrees celsius on 2 separate occasions greater than 6 hours apart
Measured: From time of delivery to time of hospital discharge; up to 6 weeks
Wound infection
Cellulitis or erythema and induration around the incision and purulent discharge from the incision site with or without fever
Measured: From time of delivery to time of hospital discharge; up to 6 weeks
Endometritis
fundal tenderness and fever that required treatment with antibiotics
Measured: From time of delivery to time of hospital discharge; up to 6 weeks
5 minute Apgar Score less than 7 out of 10
Neonatal Apgar scores consist of measurements of neonatal skin color, respiratory rate, heart rate, muscle tone, and irritability. Each parameter is given a score of 0, 1 or 2 based on standardized parameters. It is standard to perform this on all neonates at 1 minute and 5 minutes of life. Apgar scores are performed and calculated by nursing staff or members of the pediatric team. For this outcome, we are interested in scores less than 7 out of 10 at 5 minutes of life.
Measured: 5 minutes following delivery; 5 minutes of neonatal life.
Neonatal intensive care unit admission
Admission to the neonatal intensive care unit for greater than 24 hours
Measured: From time of delivery to hospital discharge; up to 6 weeks
Length of Labor
hours
Measured: Time from placement of Foley catheter to time of delivery of neonate; up to 5 days
Suspected or confirmed neonatal sepsis
As clinical suspected by the neonatology team or with positive cultures
Measured: From time of delivery to hospital discharge; up to 6 weeks
Postpartum hemorrhage
Delivery estimated blood loss of > 500 cc for vaginal delivery or > 1000 cc for cesarean delivery
Measured: From time of delivery to time of hospital discharge; up to 6 weeks
Delivery time less than 24 hours
binary; yes/no
Measured: From time of placement of Foley catheter to time of delivery of neonate; within 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study start12 Sep 2017
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Miller, Northwestern University
- Investigators
- Emily Miller, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039036
- Sponsor's protocol ID
- STU00204292
- Status last verified
- Mar 2023
- First submitted
- 15 Dec 2016
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8.
PubMed 24941926Maslow AS, Sweeny AL. Elective induction of labor as a risk factor for cesarean delivery among low-risk women at term. Obstet Gynecol. 2000 Jun;95(6 Pt 1):917-22. doi: 10.1016/s0029-7844(00)00794-8.
PubMed 10831992Garcia-Simon R, Montanes A, Clemente J, Del Pino MD, Romero MA, Fabre E, Oros D. Economic implications of labor induction. Int J Gynaecol Obstet. 2016 Apr;133(1):112-5. doi: 10.1016/j.ijgo.2015.08.022. Epub 2015 Dec 18.
PubMed 26868065Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
PubMed 23303106Smyth RM, Markham C, Dowswell T. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2013 Jun 18;2013(6):CD006167. doi: 10.1002/14651858.CD006167.pub4.
PubMed 23780653Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol. 2006 Sep;49(3):642-57. doi: 10.1097/00003081-200609000-00022.
PubMed 16885669Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
PubMed 22419277Mizrachi Y, Levy M, Bar J, Kovo M. Induction of labor in nulliparous women with unfavorable cervix: a comparison of Foley catheter and vaginal prostaglandin E2. Arch Gynecol Obstet. 2016 Oct;294(4):725-30. doi: 10.1007/s00404-016-4026-9. Epub 2016 Feb 2.
PubMed 26837386Levy R, Ferber A, Ben-Arie A, Paz B, Hazan Y, Blickstein I, Hagay ZJ. A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter. BJOG. 2002 Feb;109(2):168-72. doi: 10.1111/j.1471-0528.2002.01137.x.
PubMed 11888099Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
PubMed 27500341Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
PubMed 27824758
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction
- ClinicalTrials.gov ID
- NCT03039036
- Acronym / sponsor ID
- STU00204292
- Conditions
- Labor Induction
- Keywords
- Labor Induction, Early Amniotomy, Foley catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 1 Feb 2017 (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.
Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least 4 hours after Foley catheter removal). Other aims include the relationship between timing of amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar score <7 at 5 minutes, neonatal need for intensive care.
The investigators hypothesize that induction of labor with Foley catheters followed by early amniotomy will result in a decreased duration of labor compared to those who undergo delayed amniotomy.
Detailed description
This randomized clinical trial of consenting nulliparous women undergoing induction of labor with a Foley catheter seeks to determine whether use of early amniotomy (defined as amniotomy within 1 hour of Foley catheter removal) improves obstetrical outcomes when compared with delayed amniotomy (defined as amniotomy at least 4 hours following Foley catheter removal).
This project will include 110 women recruited from the obstetrical service at Prentice Women's Hospital. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter. Following removal of Foley catheter, women will be assessed for safety of amniotomy and if appropriate, randomized to either early amniotomy or delayed amniotomy.
Women will be randomized with equal probability to the intervention group using block randomization stratified by use of Foley catheter alone or Foley catheter-misoprostol use.
Women in the early amniotomy group will undergo amniotomy within 1 hour of Foley catheter removal. Women in the delayed amniotomy group will undergo amniotomy at least 4 hours following Foley removal. The remainder of labor management will be at the discretion of each woman's obstetric provider.
Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Amniotomy | Experimental | Procedure: Amniotomy, Device: Foley Catheter, Drug: MisoprostolPatients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy within 1 hour of Foley catheter removal. |
| Delayed Amniotomy | Active comparator | Procedure: Amniotomy, Device: Foley Catheter, Drug: MisoprostolPatients undergoing induction of labor with foley catheter, with or without concurrent use of misoprostol, will undergo amniotomy no sooner than 4 hours following removal of Foley catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to provide informed consent
- English speaking
- Women age 18 years old or greater
- Nulliparous
- Pregnant with a singleton gestation that is greater than or equal to 37 weeks
Key exclusion criteria (6 listed)
- Women not meeting above criteria
- Fetus in non-cephalic position
- Intrauterine fetal demise
- Fetus with major anomalies
- HIV, hepatitis B or C infection
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 |
|---|---|---|
| AmniotomyArtificially rupturing membranes | Procedure or surgery | Delayed Amniotomy, Early Amniotomy |
| Foley CatheterFoley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline. It is removed when either 1. it falls out under gentile traction during labor checks or 2. it is de-inflated at 12 hours after placement. If at the time of de-inflation at 12 hours, the desired affect has not been achieved, the provider may choose to place another foley balloon or use an alternative method of induction (misoprostol). This is an eligibility criteria and only patients who are undergoing induction with a Foley Catheter will be approached for enrollment. | Device | Delayed Amniotomy, Early Amniotomy |
| MisoprostolMisoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg. Use of this medication will be decided by the provider. | Drug | Delayed Amniotomy, Early Amniotomy |
Primary outcome
Time interval from Foley catheter removal to delivery
Time frame: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 hours.
Hours
11 secondary outcomes
Cesarean delivery
Time frame: At time of delivery
Chorioamnionitis
Time frame: From time of admission to Labor and Delivery unit to delivery of neonate; up to 72 hours
Postpartum Fever
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
Wound infection
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
Endometritis
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
5 minute Apgar Score less than 7 out of 10
Time frame: 5 minutes following delivery; 5 minutes of neonatal life.
Neonatal intensive care unit admission
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Length of Labor
Time frame: Time from placement of Foley catheter to time of delivery of neonate; up to 5 days
Suspected or confirmed neonatal sepsis
Time frame: From time of delivery to hospital discharge; up to 6 weeks
Postpartum hemorrhage
Time frame: From time of delivery to time of hospital discharge; up to 6 weeks
Delivery time less than 24 hours
Time frame: From time of placement of Foley catheter to time of delivery of neonate; within 24 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 3 Apr 2023.
- Background: PubMed 24941926Osterman MJ, Martin JA. Recent declines in induction of labor by gestational age. NCHS Data Brief. 2014 Jun;(155):1-8.
- Background: PubMed 10831992Maslow AS, Sweeny AL. Elective induction of labor as a risk factor for cesarean delivery among low-risk women at term. Obstet Gynecol. 2000 Jun;95(6 Pt 1):917-22. doi: 10.1016/s0029-7844(00)00794-8.
- Background: PubMed 26868065Garcia-Simon R, Montanes A, Clemente J, Del Pino MD, Romero MA, Fabre E, Oros D. Economic implications of labor induction. Int J Gynaecol Obstet. 2016 Apr;133(1):112-5. doi: 10.1016/j.ijgo.2015.08.022. Epub 2015 Dec 18.
- Background: PubMed 23303106Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
- Background: PubMed 23780653Smyth RM, Markham C, Dowswell T. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2013 Jun 18;2013(6):CD006167. doi: 10.1002/14651858.CD006167.pub4.
- Background: PubMed 16885669Gelber S, Sciscione A. Mechanical methods of cervical ripening and labor induction. Clin Obstet Gynecol. 2006 Sep;49(3):642-57. doi: 10.1097/00003081-200609000-00022.
- Background: PubMed 22419277Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
- Background: PubMed 26837386Mizrachi Y, Levy M, Bar J, Kovo M. Induction of labor in nulliparous women with unfavorable cervix: a comparison of Foley catheter and vaginal prostaglandin E2. Arch Gynecol Obstet. 2016 Oct;294(4):725-30. doi: 10.1007/s00404-016-4026-9. Epub 2016 Feb 2.
- Background: PubMed 11888099Levy R, Ferber A, Ben-Arie A, Paz B, Hazan Y, Blickstein I, Hagay ZJ. A randomised comparison of early versus late amniotomy following cervical ripening with a Foley catheter. BJOG. 2002 Feb;109(2):168-72. doi: 10.1111/j.1471-0528.2002.01137.x.
- Background: PubMed 27500341Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
- Background: PubMed 27824758Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
- Individual participant dataSharing planned: No
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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.
Emily Miller, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotomy, Foley Catheter and Misoprostol in people with Labor Induction, run by Northwestern 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 6 inclusion and 6 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 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
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?
Time interval from Foley catheter removal to delivery (time frame: Number of hours from removal of Foley catheter to delivery of neonate; up to 72 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 NCT03039036, which also lists 11 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 3 Apr 2023.