Postpartum Hemorrhage \(PPH\)NCT06166771
Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage
A study testing Alma system in people with Postpartum Hemorrhage \(PPH\) and Postpartum Hemorrhage \(Primary\), run by ResQ Medical Ltd at 1 site in Kenya.
Trial summary
Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur up to 24 hours after vaginal birth or cesarean section. In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage \(PPH\), Postpartum Hemorrhage \(Primary\), PPH
- What is being tested?
- Alma system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteKenya
- Study dates
- 9 Sep 2024to Jun 2025
- 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
- Adult Female, 18 years of age or older at time of consent.
- Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation.
- Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum > = 500 ml and according to the Investigator's judgment, require an intervention.
- Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.
Who cannot join
- Subjects who do not provide informed consent to participate in the clinical investigation.
- Subjects who deliver at a uterus size < 34 weeks.
- Subjects who have lost greater than 1000 ml of blood.
- Subjects who have abnormal PT, PTT and INR
- Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
- PPH that the investigator determines to require more aggressive treatment, including any of the following:
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- Hysterectomy;
- B-lynch suture;
- Uterine artery embolization or ligation;
- Hypogastric ligation.
- Known uterine anomaly.
- Ongoing intrauterine pregnancy.
- Placental abnormality including any of the following:
- Known placenta accreta;
- Retained placenta with known risk factors for placenta accreta (e.g., history of prior uterine surgery, including prior c-section and placenta previa);
- Retained placenta without easy manual removal.
- Known uterine rupture.
- Unresolved uterine inversion.
Trial locations and contacts
1 site in 1 country.
Kenya1 site, 1 recruiting
- Recruiting
UNIVERSITY OF NAIROBI (UoN) COLLEGE OF HEALTH SCIENCES
Nairobi
Omondi Ogutu, Prof. M.D., 254-722-510215, oomogutu@gmail.com
Alfred Osoti, Prof. M.D., alfredos@uonbi.ac.ke
About this study
Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur up to 24 hours after vaginal birth or cesarean section.
In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth.
The purpose of this prospective, non-randomized, feasibility pilot study is to obtain information on the safety and effectiveness of an investigational new medical device - Alma System, that is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
Read the detailed description
A prospective, non-randomized, feasibility pilot study that is intended to obtain information on the safety and effectiveness of the Alma System.
Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage.
The main questions are:
- Rate of device related SAEs up to six weeks following device treatment.
- Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure.
- Rate of occurrence of uterine inversion of folding during or immediately after device procedure.
Main tasks for participants:
- sign the informed Consent form and enrolment
- In case of PPH, treatment with Alma
- Participate in 2 follow-up visits After the treatment- 1st upon discharge and 2nd after 6 weeks.
- Being tested
- Alma system
- Keywords
- alma, pph, post partum hemorrhage
- Medical subject headings
- Postpartum Hemorrhage, Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alma systemDevice
Also called Vacuum induced heamorrhage control, Obstetric-gynecologic specialized manual instrument
Subjects diagnosed with postpartum hemorrhage will receive the Alma System. This system comprises a soft silicone cylindrical device placed within the uterus. Gentle suction is applied, prompting the uterus to contract and reduce in size. This contraction compresses the blood vessels, halting the bleeding.
| Study group | Role | What they receive |
|---|---|---|
| Woman who developed PPH after vaginal birth and first line therapies have been attempted and failed | Experimental | Group which Alma treatment was applied Receives: Device: Alma system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Related SAEs
Rate of device related SAEs up to six weeks following device treatment.
Measured: 6 weeks
Rate of Damage to Cervix, Uterus or Vagina
Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure
Measured: When removing the Alma System at the end of the procedure
Rate of Occurrence of Uterine Inversion or Folding
Rate of occurrence of uterine inversion or folding during or immediately after device procedure
Measured: When removing the Alma System at the end of the procedure
Secondary outcomes (4)
User Feedback on Placement of Alma
Rate of positive user feedback on device placement trans-vaginally
Measured: When removing the Alma System at the end of the procedure
User Feedback on Connection to Vacuum
Rate of positive user feedback on connection to vacuum and maintenance of desired negative pressure
Measured: When removing the Alma System at the end of the procedure
Rate of Uterine Contraction
Rate of uterine contraction to a level that reduces or stops blood flow
Measured: When removing the Alma System at the end of the procedure
Time to Visible Reduction in Blood Flow
Time from insertion and start of negative pressure to visible reduction in blood flow
Measured: When removing the Alma System at the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start9 Sep 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Hemorrhage \(PPH\)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResQ Medical Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166771
- Sponsor's protocol ID
- CD-01-001-PR
- Other IDs
- ResQ Medical IL # 516181633
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT06166771
- Acronym / sponsor ID
- CD-01-001-PR
- Keywords
- alma, pph, post partum hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ResQ Medical LtdUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Dec 2023 (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.
Postpartum Hemorrhage (PPH) is an obstetric emergency that can occur up to 24 hours after vaginal birth or cesarean section.
In most cases, the uncontrolled bleeding is due to a lack of sufficient contraction of the uterus (hypotonia) and appears immediately after birth.
The purpose of this prospective, non-randomized, feasibility pilot study is to obtain information on the safety and effectiveness of an investigational new medical device - Alma System, that is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
Detailed description
A prospective, non-randomized, feasibility pilot study that is intended to obtain information on the safety and effectiveness of the Alma System.
Study population: Women with vaginal deliveries in a hospital setting who failed first-line therapies for postpartum hemorrhage.
The main questions are:
- Rate of device related SAEs up to six weeks following device treatment.
- Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure.
- Rate of occurrence of uterine inversion of folding during or immediately after device procedure.
Main tasks for participants:
- sign the informed Consent form and enrolment
- In case of PPH, treatment with Alma
- Participate in 2 follow-up visits After the treatment- 1st upon discharge and 2nd after 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Woman who developed PPH after vaginal birth and first line therapies have been attempted and failed | Experimental | Device: Alma systemGroup which Alma treatment was applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult Female, 18 years of age or older at time of consent.
- Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation.
- Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum > = 500 ml and according to the Investigator's judgment, require an intervention.
- Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.
Key exclusion criteria (18 listed)
- Subjects who do not provide informed consent to participate in the clinical investigation.
- Subjects who deliver at a uterus size < 34 weeks.
- Subjects who have lost greater than 1000 ml of blood.
- Subjects who have abnormal PT, PTT and INR
- Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage.
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 |
|---|---|---|
| Alma systemAlso: Vacuum induced heamorrhage control, Obstetric-gynecologic specialized manual instrumentSubjects diagnosed with postpartum hemorrhage will receive the Alma System. This system comprises a soft silicone cylindrical device placed within the uterus. Gentle suction is applied, prompting the uterus to contract and reduce in size. This contraction compresses the blood vessels, halting the bleeding. | Device | Woman who developed PPH after vaginal birth and first line therapies have been attempted and failed |
Primary outcome
Rate of Related SAEs
Time frame: 6 weeks
Rate of device related SAEs up to six weeks following device treatment.
Rate of Damage to Cervix, Uterus or Vagina
Time frame: When removing the Alma System at the end of the procedure
Rate of any observable damage to cervix, uterus or vagina during or immediately after device procedure
Rate of Occurrence of Uterine Inversion or Folding
Time frame: When removing the Alma System at the end of the procedure
Rate of occurrence of uterine inversion or folding during or immediately after device procedure
4 secondary outcomes
User Feedback on Placement of Alma
Time frame: When removing the Alma System at the end of the procedure
User Feedback on Connection to Vacuum
Time frame: When removing the Alma System at the end of the procedure
Rate of Uterine Contraction
Time frame: When removing the Alma System at the end of the procedure
Time to Visible Reduction in Blood Flow
Time frame: When removing the Alma System at the end of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alma system in people with Postpartum Hemorrhage \(PPH\) and Postpartum Hemorrhage \(Primary\), run by ResQ Medical Ltd at 1 site in Kenya.
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 4 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 23 Oct 2024. 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 Kenya. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omondi Ogutu, Prof. M.D. (254-722-510215, oomogutu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Related SAEs (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2024.