Post-partum HemorrhageREBOA-PPHNCT05598502
REBOA in Life-threatening Postpartum Hemorrhage (PPH) in Uganda
A study testing REBOA, Resuscitative Endovascular Occlusion of the Aorta and National guidelines in people with Post-partum Hemorrhage, run by Centre For International Health at 1 site in Uganda.
Trial summary
Background Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum haemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda. Read more about this study
- Who is it for?
- Ages 15 to 60 years, women only
- Conditions the study is for
- Post-partum Hemorrhage
- What is being tested?
- REBOA, Resuscitative Endovascular Occlusion of the Aorta and National guidelines
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUganda
- Study dates
- 17 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with life-threatening PPH, defined as either:
- Ongoing PPH and a systolic blood pressure equal to or less than 80 mm Hg, or
- Ongoing PPH, a systolic blood pressure equal to or less than 90 mg Hg and the administration of vasoactive drugs, or
- Ongoing PPH and a systolic blood pressure equal to or less than 90 mg Hg as well as a pulse greater than or equal to 120 beats per minute recorded simultaneously
- and
- Consent, Deferred consent since 3rd September 2024
Who cannot join
- Prior cardiac arrest
- Intra-abdominal pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Open-label, Randomized Clinical Trial to Evaluate Efficacy and Safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Life-threatening Postpartum Hemorrhage in Reducing Adverse Maternal Outcome in Uganda
Background Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum haemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda.
Large parts of the monitoring of mothers during active management of third stage of labour is aiming to prevent and early detect PPH and take relevant actions. In spite of this and sometimes in referring mothers to tertiary hospitals, mothers will end up in a challenging condition where quick action is needed. A new method has proven successful for such instances, the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). This is a procedure commonly used for trauma of the lower part of the body but rarely used for PPH. A balloon catheter is inserted via the femoral artery in the groin into the aorta and then being inflated. This will prevent blood from passing to the lower part of the body, including the uterus. It will stop the bleeding and allow for the obstetrician to take relevant action. This is a safe procedure for up to 1 hour of balloon occlusion time including repeated short balloon deflations.
Read more
Objective To assess the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
Study design, setting and population A phase IIb/III, open label, 1:1 randomized clinical trial will be conducted at Kawempe National Referral Hospital, Kampala, Uganda, to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care. The inclusion criteria are: a) women with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg, b) written consent. The exclusion criterion is prior cardiac arrest or intra-abdominal pregnancy. The sample size of the trial will be 212 participants. Enrolment will follow a group sequential design approach with two interim analyses at 50% and 85% of the total sample size, and a final analysis with full sample size.
Utility of the study It is crucial to explore alternative modalities that could prevent adverse maternal outcomes in life-threatening postpartum haemorrhage in Uganda and the rest of the world.
Read the detailed description
Background
Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum hemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda.
Large parts of the monitoring of mothers during active management of third stage of labor is aiming to prevent and early detect PPH and take relevant actions. In spite of this and sometimes in referring mothers to tertiary hospitals, mothers will end up in a challenging condition where quick action is needed. A new method has proven successful for such instances, the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). This is a procedure commonly used for trauma of the lower part of the body but rarely used for PPH. In this trial, it is done by an anesthesiologist where a balloon catheter is inserted via the femoral artery in the groin into the aorta and then being inflated. This will prevent blood from passing to the lower part of the body, including the uterus. It will stop the bleeding and allow for the obstetrician to take relevant action. This is a safe procedure for up to 1 hour of inflation.
Objective
To assess the efficacy and safety of the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum hemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
Primary objectives
- To assess if the proportion of participants with either maternal death and/or emergency hysterectomy, can be decreased from 50 % in the comparator arm (using standard of care alone) to 30 % or less in the intervention arm (using standard of care plus REBOA).
- To assess the safety of REBOA in a national referral hospital in a low-income country like Uganda.
Secondary objectives
- To assess if the proportion of participants with either maternal death and/or emergency hysterectomy is lower in the intervention arm when excluding 'inevitable' hysterectomies due to either an irreparable uterine rupture, a pathological placenta growing into the uterus (placenta accreta, increta or percreta) or a pathological uterus, such as a bicorne uterus or one with very large fibroids.
- To assess if the proportion of participants with maternal deaths is lower in the intervention arm compared to the comparator arm.
- To assess if the proportion of participants with emergency hysterectomy, is lower in the intervention arm compared to the comparator arm.
- To assess if the number of participants with acute kidney injury 35is lower in the intervention arm compared to the comparator arm
- To assess if the number of blood transfusion units is lower in the intervention arm compared to the comparator arm.
- To assess if post-partum haemoglobin concentration is higher in in the intervention arm compared to the comparator arm.
- To assess the time to insert the REBOA.
Study design, setting and population The trial design will be a seamless phase IIb/III study. The study will start with a phase IIb study where the focus is on assessing the safety of REBOA use in a national referral hospital in a low-income country like Uganda. In this phase there will be 10 participants recruited consecutively to intervention arm (REBOA) without randomisation. The aim of the pilot phase is to demonstrate that the REBOA procedure is safe and feasible in the patient cohort.
The phase III trial is a randomised, controlled, open-label, superiority trial among women with life-threatening post-partum haemorrhage with two parallel arms and a primary endpoint of either death or hysterectomy. Individual randomisation will be performed as block randomization with a 1:1 allocation.
The trial will be conducted at Kawempe National Referral Hospital, Kampala, Uganda.
The sample size of the trial will be 212 participants. Enrolment will follow a group sequential design approach with two interim analyses at 1/2 and 85% of the total sample size, and a final analysis with full sample size.
Results from Norway indicate that REBOA could be an efficient way to prevent post-partum hemorrhage ending in an adverse outcome such as death or emergency hysterectomy. It is not clear whether these results can be reproduced in a low-income setting where PPH is more prevalent, and resources are scarce. The REBOA device could reduce the risk of adverse outcome such as death or emergency hysterectomy. It will be compared to standard of care.
Utility of the study
It is crucial to explore alternative modalities that could prevent adverse maternal outcomes in life-threatening postpartum hemorrhage in Uganda and the rest of the world.
- Conditions
- Post-partum Hemorrhage
- Being tested
- REBOA, Resuscitative Endovascular Occlusion of the Aorta, National guidelines
- Keywords
- REBOA, Resuscitative Endovascular Occlusion of the Aorta
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REBOA, Resuscitative Endovascular Occlusion of the AortaDevice
The balloon catheter is inserted via the common femoral artery in the groin, accessed under ultrasound guidance due to weak femoral pulses, and the puncture is done by the Seldinger technique. The balloon is inserted along a guidewire 25-30 cm, safely below the renal arteries, to be in the right place to stop pelvic hemorrhage including life-threatening post-partum hemorrhage
National guidelinesOther
Standard management of postpartum hemorrhage according to Uganda national guidelines
| Study group | Role | What they receive |
|---|---|---|
| REBOA | Experimental | Addition of REBOA (Resuscitative Endovascular Occlusion of the Aorta) Receives: Device: REBOA, Resuscitative Endovascular Occlusion of the Aorta; Other: National guidelines |
| National guidelines | Active comparator | Treatment according to Uganda national guidelines for post-partum hemorrhage. Receives: Other: National guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse outcome
The proportion of participants with a composite outcome of either maternal death (=death within 42 days post-partum) or emergency hysterectomy
Measured: 42 days
Secondary outcomes (7)
Adverse outcome excluding 'inevitable' hysterectomies
The proportion of participants with a composite outcome of either maternal death (=death within 42 days post-partum) or emergency hysterectomy due to either an irreparable uterine rupture, a pathological placenta growing into the uterus (placenta accreta, increta or percreta) or a pathological uterus, such as a bicorne uterus or one with very large fibroids
Measured: 42 days
Number of AEs and SAEs
Safety of REBOA assessed by AEs and SAEs
Measured: 42 days
Maternal death
The proportion of participants with a maternal death
Measured: 42 days
Emergency hysterectomy
The proportion of participants with emergency hysterectomy
Measured: 42 days
Acute kidney injury
The proportion of participants with acute kidney injury
Measured: 42 days
Transfusions
The number of blood transfusion units
Measured: 42 days
Hemoglobin
Post-partum hemoglobin concentration at day 0, 3 and 42
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start17 Jan 2024
- Primary completion31 Jan 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-partum 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual randomization
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre For International Health
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Kawempe National Referral Hospital, St. Olavs Hospital, Helse Stavanger HF, University of Liverpool, University of Padova
- Responsible party
- Sponsor
- Investigators
- Thorkild Tylleskar, MD, PhD, Principal investigator, University of Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598502
- Sponsor's protocol ID
- Mak-UiB 102
- Acronym
- REBOA-PPH
- Status last verified
- Apr 2025
- First submitted
- 25 Oct 2022
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stensaeth KH, Sovik E, Haig IN, Skomedal E, Jorgensen A. Fluoroscopy-free Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for controlling life threatening postpartum hemorrhage. PLoS One. 2017 Mar 29;12(3):e0174520. doi: 10.1371/journal.pone.0174520. eCollection 2017.
PubMed 28355242Webster LA, Little O, Villalobos A, Nguyen J, Nezami N, Lilly M, Dariushnia S, Gandhi R, Kokabi N. REBOA: Expanding Applications From Traumatic Hemorrhage to Obstetrics and Cardiopulmonary Resuscitation, From the AJR Special Series on Emergency Radiology. AJR Am J Roentgenol. 2023 Jan;220(1):16-22. doi: 10.2214/AJR.22.27932. Epub 2022 Aug 3.
PubMed 35920708Brede JR, Sovik E, Rehn M. Resuscitative endovascular balloon occlusion of the aorta: the postpartum haemorrhage perspective. Crit Care. 2022 Mar 11;26(1):57. doi: 10.1186/s13054-022-03942-0. No abstract available.
PubMed 35277189Brede JR, Rehn M. The end of balloons? Our take on the UK-REBOA trial. Scand J Trauma Resusc Emerg Med. 2023 Oct 31;31(1):69. doi: 10.1186/s13049-023-01142-5.
PubMed 37908007
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open-label, Randomized Clinical Trial to Evaluate Efficacy and Safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in Life-threatening Postpartum Hemorrhage in Reducing Adverse Maternal Outcome in Uganda
- ClinicalTrials.gov ID
- NCT05598502
- Acronym / sponsor ID
- REBOA-PPH / Mak-UiB 102
- Conditions
- Post-partum Hemorrhage
- Keywords
- REBOA, Resuscitative Endovascular Occlusion of the Aorta
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Centre For International HealthUniversity, hospital or other
- Collaborators
- Makerere University, Kawempe National Referral Hospital, St. Olavs Hospital, Helse Stavanger HF, University of Liverpool, University of Padova
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Oct 2022 (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.
Background Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum haemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda.
Large parts of the monitoring of mothers during active management of third stage of labour is aiming to prevent and early detect PPH and take relevant actions. In spite of this and sometimes in referring mothers to tertiary hospitals, mothers will end up in a challenging condition where quick action is needed. A new method has proven successful for such instances, the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). This is a procedure commonly used for trauma of the lower part of the body but rarely used for PPH. A balloon catheter is inserted via the femoral artery in the groin into the aorta and then being inflated. This will prevent blood from passing to the lower part of the body, including the uterus. It will stop the bleeding and allow for the obstetrician to take relevant action. This is a safe procedure for up to 1 hour of balloon occlusion time including repeated short balloon deflations.
Objective To assess the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
Study design, setting and population A phase IIb/III, open label, 1:1 randomized clinical trial will be conducted at Kawempe National Referral Hospital, Kampala, Uganda, to evaluate the efficacy and safety of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum haemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care. The inclusion criteria are: a) women with life-threatening PPH and a systolic blood pressure equal to or less than 80 mmHg, b) written consent. The exclusion criterion is prior cardiac arrest or intra-abdominal pregnancy. The sample size of the trial will be 212 participants. Enrolment will follow a group sequential design approach with two interim analyses at 50% and 85% of the total sample size, and a final analysis with full sample size.
Utility of the study It is crucial to explore alternative modalities that could prevent adverse maternal outcomes in life-threatening postpartum haemorrhage in Uganda and the rest of the world.
Detailed description
Background
Maternal mortality rates in many low-income countries (LMICs) remain high. The most prominent cause is bleeding after birth, called postpartum hemorrhage (PPH). In a recent report from Uganda, bleeding is the cause of 42% of all maternal deaths in Uganda.
Large parts of the monitoring of mothers during active management of third stage of labor is aiming to prevent and early detect PPH and take relevant actions. In spite of this and sometimes in referring mothers to tertiary hospitals, mothers will end up in a challenging condition where quick action is needed. A new method has proven successful for such instances, the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA). This is a procedure commonly used for trauma of the lower part of the body but rarely used for PPH. In this trial, it is done by an anesthesiologist where a balloon catheter is inserted via the femoral artery in the groin into the aorta and then being inflated. This will prevent blood from passing to the lower part of the body, including the uterus. It will stop the bleeding and allow for the obstetrician to take relevant action. This is a safe procedure for up to 1 hour of inflation.
Objective
To assess the efficacy and safety of the use of Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) in life-threatening postpartum hemorrhage (PPH) in reducing adverse maternal outcome compared to standard of care in Uganda.
Primary objectives
- To assess if the proportion of participants with either maternal death and/or emergency hysterectomy, can be decreased from 50 % in the comparator arm (using standard of care alone) to 30 % or less in the intervention arm (using standard of care plus REBOA).
- To assess the safety of REBOA in a national referral hospital in a low-income country like Uganda.
Secondary objectives
- To assess if the proportion of participants with either maternal death and/or emergency hysterectomy is lower in the intervention arm when excluding 'inevitable' hysterectomies due to either an irreparable uterine rupture, a pathological placenta growing into the uterus (placenta accreta, increta or percreta) or a pathological uterus, such as a bicorne uterus or one with very large fibroids.
- To assess if the proportion of participants with maternal deaths is lower in the intervention arm compared to the comparator arm.
- To assess if the proportion of participants with emergency hysterectomy, is lower in the intervention arm compared to the comparator arm.
- To assess if the number of participants with acute kidney injury 35is lower in the intervention arm compared to the comparator arm
- To assess if the number of blood transfusion units is lower in the intervention arm compared to the comparator arm.
- To assess if post-partum haemoglobin concentration is higher in in the intervention arm compared to the comparator arm.
- To assess the time to insert the REBOA.
Study design, setting and population The trial design will be a seamless phase IIb/III study. The study will start with a phase IIb study where the focus is on assessing the safety of REBOA use in a national referral hospital in a low-income country like Uganda. In this phase there will be 10 participants recruited consecutively to intervention arm (REBOA) without randomisation. The aim of the pilot phase is to demonstrate that the REBOA procedure is safe and feasible in the patient cohort.
The phase III trial is a randomised, controlled, open-label, superiority trial among women with life-threatening post-partum haemorrhage with two parallel arms and a primary endpoint of either death or hysterectomy. Individual randomisation will be performed as block randomization with a 1:1 allocation.
The trial will be conducted at Kawempe National Referral Hospital, Kampala, Uganda.
The sample size of the trial will be 212 participants. Enrolment will follow a group sequential design approach with two interim analyses at 1/2 and 85% of the total sample size, and a final analysis with full sample size.
Results from Norway indicate that REBOA could be an efficient way to prevent post-partum hemorrhage ending in an adverse outcome such as death or emergency hysterectomy. It is not clear whether these results can be reproduced in a low-income setting where PPH is more prevalent, and resources are scarce. The REBOA device could reduce the risk of adverse outcome such as death or emergency hysterectomy. It will be compared to standard of care.
Utility of the study
It is crucial to explore alternative modalities that could prevent adverse maternal outcomes in life-threatening postpartum hemorrhage in Uganda and the rest of the world.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individual randomization
| Arm | Type | Receives |
|---|---|---|
| REBOA | Experimental | Device: REBOA, Resuscitative Endovascular Occlusion of the Aorta, Other: National guidelinesAddition of REBOA (Resuscitative Endovascular Occlusion of the Aorta) |
| National guidelines | Active comparator | Other: National guidelinesTreatment according to Uganda national guidelines for post-partum hemorrhage. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with life-threatening PPH, defined as either:
- and
- Consent, Deferred consent since 3rd September 2024
Key exclusion criteria (2 listed)
- Prior cardiac arrest
- Intra-abdominal pregnancy
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 |
|---|---|---|
| REBOA, Resuscitative Endovascular Occlusion of the AortaThe balloon catheter is inserted via the common femoral artery in the groin, accessed under ultrasound guidance due to weak femoral pulses, and the puncture is done by the Seldinger technique. The balloon is inserted along a guidewire 25-30 cm, safely below the renal arteries, to be in the right place to stop pelvic hemorrhage including life-threatening post-partum hemorrhage | Device | REBOA |
| National guidelinesStandard management of postpartum hemorrhage according to Uganda national guidelines | Other | National guidelines, REBOA |
Primary outcome
Adverse outcome
Time frame: 42 days
The proportion of participants with a composite outcome of either maternal death (=death within 42 days post-partum) or emergency hysterectomy
7 secondary outcomes
Adverse outcome excluding 'inevitable' hysterectomies
Time frame: 42 days
Number of AEs and SAEs
Time frame: 42 days
Maternal death
Time frame: 42 days
Emergency hysterectomy
Time frame: 42 days
Acute kidney injury
Time frame: 42 days
Transfusions
Time frame: 42 days
Hemoglobin
Time frame: 42 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 28355242Stensaeth KH, Sovik E, Haig IN, Skomedal E, Jorgensen A. Fluoroscopy-free Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) for controlling life threatening postpartum hemorrhage. PLoS One. 2017 Mar 29;12(3):e0174520. doi: 10.1371/journal.pone.0174520. eCollection 2017.
- Background: PubMed 35920708Webster LA, Little O, Villalobos A, Nguyen J, Nezami N, Lilly M, Dariushnia S, Gandhi R, Kokabi N. REBOA: Expanding Applications From Traumatic Hemorrhage to Obstetrics and Cardiopulmonary Resuscitation, From the AJR Special Series on Emergency Radiology. AJR Am J Roentgenol. 2023 Jan;220(1):16-22. doi: 10.2214/AJR.22.27932. Epub 2022 Aug 3.
- Background: PubMed 35277189Brede JR, Sovik E, Rehn M. Resuscitative endovascular balloon occlusion of the aorta: the postpartum haemorrhage perspective. Crit Care. 2022 Mar 11;26(1):57. doi: 10.1186/s13054-022-03942-0. No abstract available.
- Background: PubMed 37908007Brede JR, Rehn M. The end of balloons? Our take on the UK-REBOA trial. Scand J Trauma Resusc Emerg Med. 2023 Oct 31;31(1):69. doi: 10.1186/s13049-023-01142-5.
- 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.
Thorkild Tylleskar, MD, PhD principal investigator
University of Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REBOA, Resuscitative Endovascular Occlusion of the Aorta and National guidelines in people with Post-partum Hemorrhage, run by Centre For International Health at 1 site in Uganda.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2025. 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 Uganda. 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?
This study is still under way. Results are not available in the source record yet.
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?
Adverse outcome (time frame: 42 days). 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 NCT05598502, which also lists 4 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 8 Apr 2025.