Postpartum HemorrhageRUBYNCT04995887
RUBY Post-Market Registry on the Jada® System
An observational study of Postpartum Hemorrhage, run by Alydia Health at 16 sites in United States.
Trial summary
The RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Jada® System
- Type of treatment
- Medical device
- How many people
- 809 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Oct 2020to 30 Apr 2022
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients included are all identified through review of the medical charts as having received Jada treatment starting from the center's first commercial use of the Jada System. This chart review will be ongoing until the specified date or until a minimum of 100 patients are enrolled in each of the groups described below (whichever occurs first): 1. ≥ 1500 mL estimated blood loss (EBL) at time of Jada insertion (C-S) 2. < 1500 mL EBL at time of Jada insertion (C-S) 3. ≥ 1000 mL EBL at time of Jada insertion (vaginal) 4. < 1000 mL EBL at time of Jada insertion (vaginal) Up to a maximum of 50 sites can be included in this registry. Each IRB approval constitutes a "site."
Who may be able to join
- Use of the Jada System (inserted into the patient and connected to vacuum).
- NOTE: There is no Exclusion Criteria in this protocol.
Who cannot join
None listed.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Charleston Area Medical Center
Charleston, West Virginia, 25302
University Hospitals
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University
Columbus, Ohio, 43210
Ohio Health
Gahanna, Ohio, 43230
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Loma Linda University
Loma Linda, California, 92354
Allina (Abbott Northwestern)
Minneapolis, Minnesota, 55409
Charleston Birth Place
Mt. Pleasant, South Carolina, 29464
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Oshsner Baptist
New Orleans, Louisiana, 70115
Mount Sinai
New York, New York, 10029
Nyph/Cumc
New York, New York, 10032
ChristianaCare
Newark, Delaware, 19718
UPMC - Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: RUBY: Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage With the Jada® System - A Post-Market Registry
The RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting.
Read the detailed description
The purpose of this registry is to collect observational data on patients treated with the Jada System in the post-market setting. Data collection will include observations of effectiveness and safety of the device. Additional outcome data related to resource utilization will also be included.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Jada® System
- Keywords
- Vacuum-Induced Hemorrhage-Control (VHC), Jada, Postpartum Hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jada® SystemDevice
Also called Vacuum-induced Hemorrhage Control, Obstetric-Gynecologic Specialized Manual Instrument
The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.
| Study group | Role | What they receive |
|---|---|---|
| C-Section Delivery with EBL ≥ 1500 mL | Patients with ≥ 1500 mL estimated blood loss (EBL) at time of Jada insertion for cesarean delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). Receives: Device: Jada® System | |
| C-Section Delivery with EBL < 1500 mL | Patients with < 1500 mL EBL at time of Jada insertion for cesarean delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). Receives: Device: Jada® System | |
| Vaginal Delivery with EBL ≥ 1000 mL | Patients with ≥ 1000 mL EBL at time of Jada insertion for vaginal delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). Receives: Device: Jada® System | |
| Vaginal Delivery with EBL < 1000 mL | Patients with < 1000 mL EBL at time of Jada insertion for vaginal delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). Receives: Device: Jada® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Cessation of PPH
Proportion of patients with atony-related abnormal postpartum uterine bleeding or PPH successfully treated with the Jada System. Treatment success is defined as the avoidance of escalated non-surgical or surgical intervention to control abnormal postpartum uterine bleeding or PPH after the Jada System was used.
Note: Concomitant treatment with uterotonics or uterine compression sutures does not constitute escalation (i.e., failure). However, if the Jada treatment was aborted to instead administer treatment with compression sutures for ongoing bleeding, then the event does meet the escalation (i.e., failure) definition.
Measured: 24 hours
Safety: device-related Adverse Events
Rates of procedure- and device-related adverse events.
Measured: 24 hours through time of discharge.
Secondary outcomes (5)
Rate of non-surgical or surgical procedures other than Jada
Rate of non-surgical or surgical procedures other than Jada for atony-related bleeding after Jada was used
Measured: 24 hours
Transfusion rates
Rate of blood transfusions
Measured: 24 hours through time of discharge.
In-dwelling time of Jada during treatment
In-dwelling time (i.e., insertion of Jada to removal of Jada)
Measured: 24 hours
Time spent in care settings
Time spent in care settings (e.g., L\&D, OR, Delivery Room, Postpartum Room, ICU, Other) from Jada treatment through discharge
Measured: 24 hours through time of discharge.
Length of stay
Length of stay (LOS) from delivery to discharge
Measured: 24 hours through time of discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Oct 2020
- Primary completion31 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 809 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alydia Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dena Goffman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995887
- Sponsor's protocol ID
- CIP-05 v1.0
- Other IDs
- Protocol No. PPH-05
- Acronym
- RUBY
- Status last verified
- Aug 2022
- First submitted
- 13 Jul 2021
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Gulmezoglu AM, Lawrie TA, Hezelgrave N, Oladapo OT, Souza JP, Gielen M, Lawn JE, Bahl R, Althabe F, Colaci D, Hofmeyr GJ. Interventions to Reduce Maternal and Newborn Morbidity and Mortality. In: Black RE, Laxminarayan R, Temmerman M, Walker N, editors. Reproductive, Maternal, Newborn, and Child Health: Disease Control Priorities, Third Edition (Volume 2). Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2016 Apr 5. Chapter 7. Available from http://www.ncbi.nlm.nih.gov/books/NBK361904/
PubMed 27227224Callaghan WM, Kuklina EV, Berg CJ. Trends in postpartum hemorrhage: United States, 1994-2006. Am J Obstet Gynecol. 2010 Apr;202(4):353.e1-6. doi: 10.1016/j.ajog.2010.01.011.
PubMed 20350642Mulic-Lutvica A, Bekuretsion M, Bakos O, Axelsson O. Ultrasonic evaluation of the uterus and uterine cavity after normal, vaginal delivery. Ultrasound Obstet Gynecol. 2001 Nov;18(5):491-8. doi: 10.1046/j.0960-7692.2001.00561.x.
PubMed 11844171Andersen HF, Hopkins MP. Chapter 80: postpartum hemorrhage. In: Sciarra JJ, editor. Gynecology and obstetrics, volume 2. Philadelphia, PA: Lippincott Williams & Wilkins; 2004.
Lyon DS. Chapter 90: postpartum care. In: Sciarra JJ, editor. Gynecology and obstetrics, volume 2. Philadelphia, PA: Lippincott Williams & Wilkins; 2004.
Baskett TF. A flux of the reds: evolution of active management of the third stage of labour. J R Soc Med. 2000 Sep;93(9):489-93. doi: 10.1177/014107680009300913. No abstract available.
PubMed 11089490Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS; National Partnership for Maternal Safety; Council on Patient Safety in Women's Health Care. National Partnership for Maternal Safety: Consensus Bundle on Obstetric Hemorrhage. Obstet Gynecol. 2015 Jul;126(1):155-62. doi: 10.1097/AOG.0000000000000869.
PubMed 26241269Goffman D, Ananth CV, Fleischer A, D'Alton M, Lavery JA, Smiley R, Zielinski K, Chazotte C; Safe Motherhood Initiative Obstetric Hemorrhage Work Group. The New York State Safe Motherhood Initiative: Early Impact of Obstetric Hemorrhage Bundle Implementation. Am J Perinatol. 2019 Nov;36(13):1344-1350. doi: 10.1055/s-0038-1676976. Epub 2019 Jan 4.
PubMed 30609429Shields LE, Smalarz K, Reffigee L, Mugg S, Burdumy TJ, Propst M. Comprehensive maternal hemorrhage protocols improve patient safety and reduce utilization of blood products. Am J Obstet Gynecol. 2011 Oct;205(4):368.e1-8. doi: 10.1016/j.ajog.2011.06.084. Epub 2011 Jun 29.
PubMed 22083059Rossen J, Okland I, Nilsen OB, Eggebo TM. Is there an increase of postpartum hemorrhage, and is severe hemorrhage associated with more frequent use of obstetric interventions? Acta Obstet Gynecol Scand. 2010 Oct;89(10):1248-55. doi: 10.3109/00016349.2010.514324.
PubMed 20809871Della Torre M, Kilpatrick SJ, Hibbard JU, Simonson L, Scott S, Koch A, Schy D, Geller SE. Assessing preventability for obstetric hemorrhage. Am J Perinatol. 2011 Dec;28(10):753-60. doi: 10.1055/s-0031-1280856. Epub 2011 Jun 22.
PubMed 21698554American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage. Obstet Gynecol. 2006 Oct;108(4):1039-47. doi: 10.1097/00006250-200610000-00046.
PubMed 17012482Zelop CM. Postpartum hemorrhage: becoming more evidence-based. Obstet Gynecol. 2011 Jan;117(1):3-5. doi: 10.1097/AOG.0b013e318202ec9a. No abstract available.
PubMed 21173639Purwosunu Y, Sarkoen W, Arulkumaran S, Segnitz J. Control of Postpartum Hemorrhage Using Vacuum-Induced Uterine Tamponade. Obstet Gynecol. 2016 Jul;128(1):33-36. doi: 10.1097/AOG.0000000000001473.
PubMed 27275795D'Alton ME, Rood KM, Smid MC, Simhan HN, Skupski DW, Subramaniam A, Gibson KS, Rosen T, Clark SM, Dudley D, Iqbal SN, Paglia MJ, Duzyj CM, Chien EK, Gibbins KJ, Wine KD, Bentum NAA, Kominiarek MA, Tuuli MG, Goffman D. Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2020 Nov;136(5):882-891. doi: 10.1097/AOG.0000000000004138.
PubMed 32909970
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RUBY: Treating Abnormal Postpartum Uterine Bleeding or Postpartum Hemorrhage With the Jada® System - A Post-Market Registry
- ClinicalTrials.gov ID
- NCT04995887
- Acronym / sponsor ID
- RUBY / CIP-05 v1.0
- Conditions
- Postpartum Hemorrhage
- Keywords
- Vacuum-Induced Hemorrhage-Control (VHC), Jada, Postpartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 809 participants (actual)
- Lead sponsor
- Alydia HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 9 Aug 2021 (actual)
- 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 RUBY Study is a multicenter, observational, post-market registry designed to collect observational data on patients treated with the Jada System in the post-market setting.
Detailed description
The purpose of this registry is to collect observational data on patients treated with the Jada System in the post-market setting. Data collection will include observations of effectiveness and safety of the device. Additional outcome data related to resource utilization will also be included.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| C-Section Delivery with EBL ≥ 1500 mL | – | Device: Jada® SystemPatients with ≥ 1500 mL estimated blood loss (EBL) at time of Jada insertion for cesarean delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). |
| C-Section Delivery with EBL < 1500 mL | – | Device: Jada® SystemPatients with < 1500 mL EBL at time of Jada insertion for cesarean delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). |
| Vaginal Delivery with EBL ≥ 1000 mL | – | Device: Jada® SystemPatients with ≥ 1000 mL EBL at time of Jada insertion for vaginal delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). |
| Vaginal Delivery with EBL < 1000 mL | – | Device: Jada® SystemPatients with < 1000 mL EBL at time of Jada insertion for vaginal delivery; data collection will continue until a minimum of 100 patients are enrolled in each group/category or until March 31, 2022 (whichever occurs first). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients included are all identified through review of the medical charts as having received Jada treatment starting from the center's first commercial use of the Jada System. This chart review will be ongoing until the specified date or until a minimum of 100 patients are enrolled in each of the groups described below (whichever occurs first): 1. ≥ 1500 mL estimated blood loss (EBL) at time of Jada insertion (C-S) 2. < 1500 mL EBL at time of Jada insertion (C-S) 3. ≥ 1000 mL EBL at time of Jada insertion (vaginal) 4. < 1000 mL EBL at time of Jada insertion (vaginal) Up to a maximum of 50 sites can be included in this registry. Each IRB approval constitutes a "site."
Key inclusion criteria (2 listed)
- Use of the Jada System (inserted into the patient and connected to vacuum).
- NOTE: There is no Exclusion Criteria in this protocol.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Jada® SystemAlso: Vacuum-induced Hemorrhage Control, Obstetric-Gynecologic Specialized Manual InstrumentThe Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops. | Device | C-Section Delivery with EBL < 1500 mL, C-Section Delivery with EBL ≥ 1500 mL, Vaginal Delivery with EBL < 1000 mL, Vaginal Delivery with EBL ≥ 1000 mL |
Primary outcome
Efficacy: Cessation of PPH
Time frame: 24 hours
Proportion of patients with atony-related abnormal postpartum uterine bleeding or PPH successfully treated with the Jada System. Treatment success is defined as the avoidance of escalated non-surgical or surgical intervention to control abnormal postpartum uterine bleeding or PPH after the Jada System was used. Note: Concomitant treatment with uterotonics or uterine compression sutures does not constitute escalation (i.e., failure). However, if the Jada treatment was aborted to instead administer treatment with compression sutures for ongoing bleeding, then the event does meet the escalation (i.e., failure) definition.
Safety: device-related Adverse Events
Time frame: 24 hours through time of discharge.
Rates of procedure- and device-related adverse events.
5 secondary outcomes
Rate of non-surgical or surgical procedures other than Jada
Time frame: 24 hours
Transfusion rates
Time frame: 24 hours through time of discharge.
In-dwelling time of Jada during treatment
Time frame: 24 hours
Time spent in care settings
Time frame: 24 hours through time of discharge.
Length of stay
Time frame: 24 hours through time of discharge.
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 22 Aug 2022.
- Background: PubMed 27227224Gulmezoglu AM, Lawrie TA, Hezelgrave N, Oladapo OT, Souza JP, Gielen M, Lawn JE, Bahl R, Althabe F, Colaci D, Hofmeyr GJ. Interventions to Reduce Maternal and Newborn Morbidity and Mortality. In: Black RE, Laxminarayan R, Temmerman M, Walker N, editors. Reproductive, Maternal, Newborn, and Child Health: Disease Control Priorities, Third Edition (Volume 2). Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2016 Apr 5. Chapter 7. Available from http://www.ncbi.nlm.nih.gov/books/NBK361904/
- Background: PubMed 20350642Callaghan WM, Kuklina EV, Berg CJ. Trends in postpartum hemorrhage: United States, 1994-2006. Am J Obstet Gynecol. 2010 Apr;202(4):353.e1-6. doi: 10.1016/j.ajog.2010.01.011.
- Background: PubMed 11844171Mulic-Lutvica A, Bekuretsion M, Bakos O, Axelsson O. Ultrasonic evaluation of the uterus and uterine cavity after normal, vaginal delivery. Ultrasound Obstet Gynecol. 2001 Nov;18(5):491-8. doi: 10.1046/j.0960-7692.2001.00561.x.
- BackgroundAndersen HF, Hopkins MP. Chapter 80: postpartum hemorrhage. In: Sciarra JJ, editor. Gynecology and obstetrics, volume 2. Philadelphia, PA: Lippincott Williams & Wilkins; 2004.
- BackgroundLyon DS. Chapter 90: postpartum care. In: Sciarra JJ, editor. Gynecology and obstetrics, volume 2. Philadelphia, PA: Lippincott Williams & Wilkins; 2004.
- Background: PubMed 11089490Baskett TF. A flux of the reds: evolution of active management of the third stage of labour. J R Soc Med. 2000 Sep;93(9):489-93. doi: 10.1177/014107680009300913. No abstract available.
- Background: PubMed 26241269Main EK, Goffman D, Scavone BM, Low LK, Bingham D, Fontaine PL, Gorlin JB, Lagrew DC, Levy BS; National Partnership for Maternal Safety; Council on Patient Safety in Women's Health Care. National Partnership for Maternal Safety: Consensus Bundle on Obstetric Hemorrhage. Obstet Gynecol. 2015 Jul;126(1):155-62. doi: 10.1097/AOG.0000000000000869.
- Background: PubMed 30609429Goffman D, Ananth CV, Fleischer A, D'Alton M, Lavery JA, Smiley R, Zielinski K, Chazotte C; Safe Motherhood Initiative Obstetric Hemorrhage Work Group. The New York State Safe Motherhood Initiative: Early Impact of Obstetric Hemorrhage Bundle Implementation. Am J Perinatol. 2019 Nov;36(13):1344-1350. doi: 10.1055/s-0038-1676976. Epub 2019 Jan 4.
- Background: PubMed 22083059Shields LE, Smalarz K, Reffigee L, Mugg S, Burdumy TJ, Propst M. Comprehensive maternal hemorrhage protocols improve patient safety and reduce utilization of blood products. Am J Obstet Gynecol. 2011 Oct;205(4):368.e1-8. doi: 10.1016/j.ajog.2011.06.084. Epub 2011 Jun 29.
- Background: PubMed 20809871Rossen J, Okland I, Nilsen OB, Eggebo TM. Is there an increase of postpartum hemorrhage, and is severe hemorrhage associated with more frequent use of obstetric interventions? Acta Obstet Gynecol Scand. 2010 Oct;89(10):1248-55. doi: 10.3109/00016349.2010.514324.
- Background: PubMed 21698554Della Torre M, Kilpatrick SJ, Hibbard JU, Simonson L, Scott S, Koch A, Schy D, Geller SE. Assessing preventability for obstetric hemorrhage. Am J Perinatol. 2011 Dec;28(10):753-60. doi: 10.1055/s-0031-1280856. Epub 2011 Jun 22.
- Background: PubMed 17012482American College of Obstetricians and Gynecologists. ACOG Practice Bulletin: Clinical Management Guidelines for Obstetrician-Gynecologists Number 76, October 2006: postpartum hemorrhage. Obstet Gynecol. 2006 Oct;108(4):1039-47. doi: 10.1097/00006250-200610000-00046.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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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.
Dena Goffman, MD principal investigator
Columbia University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage, run by Alydia Health at 16 sites 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 2 inclusion and 0 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 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
Efficacy: Cessation of PPH (time frame: 24 hours). 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 NCT04995887, which also lists 17 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 22 Aug 2022.