Postpartum Haemorrhage (PPH)Phase 3EVENCT06646653
EVE TRIAL , ALMA SYSTAM
A Phase 3 study testing Alma System in people with Postpartum Haemorrhage (PPH) and PPH, run by ResQ Medical Ltd at 2 sites in 2 countries.
Trial summary
abnormal bleeding after childbirth. This condition is called abnormal bleeding and becomes a condition known as postpartum hemorrhage (PPH) when worsens. Abnormal bleeding is defined as the loss of more than 500 milliliters (about two cups) of blood after a vaginal birth, or more than 1,000 milliliters (about four… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Haemorrhage (PPH), PPH, Postpartum Hemorrhage (Primary)
- 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
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Jan 2026to Apr 2027
- Phase
- Phase 3
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
- Adult Female, 18 years of age or older at time of consent.
- Able to understand and provide informed consent to participate in the study.
- Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery.
- EBL, determined when investigator is ready to have the Alma peel pack opened: Vaginal delivery: 500 - 1500 ml EBL or C-section delivery 1000 - 1500 ml EBL
- Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.
Note: Uterotonic administration may continue concomitantly with and post Alma use, as long as such use does not exceed the maximum dose of the drug 10.3.2 Exclusion Criteria
- EBL >1500ml, to be determined when investigator is ready to have the Alma peel pack opened.
- Delivery at a gestational age < 34 weeks.
- For Cesarean-sections birth: Cervix < 3 cm dilated before use of Alma.
- PPH that the investigator determines to require more aggressive treatment, including any of the following:
- hysterectomy;
- b-lynch suture;
- uterine artery embolization or ligation;
- hypogastric ligation.
- Known uterine anomaly.
- Ongoing intrauterine pregnancy.
- Placenta 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.
- Subject has undergone intrauterine balloon therapy or uterine packing or use of other negative pressure system(s) for tamponade treatment of this PPH prior to use of Alma.
- Current cervical cancer.
- Current purulent infection of vagina, cervix, uterus.
- Diagnosis of coagulopathy.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Not yet recruiting
Maimonides Medical Center | Brooklyn, New York Hospital
Brooklyn, New York, 11219
Itamar Futterman, MD, 9179220515, ifutterman@maimo.org
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
Hen Sela, MD, 972-507874676, hysela@szmc.org.il
About this study
Official title: Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Alma System in Treating Abnormal Postpartum utErine Bleeding or Hemorrhage
abnormal bleeding after childbirth. This condition is called abnormal bleeding and becomes a condition known as postpartum hemorrhage (PPH) when worsens. Abnormal bleeding is defined as the loss of more than 500 milliliters (about two cups) of blood after a vaginal birth, or more than 1,000 milliliters (about four cups) after a cesarean section. It is a serious and potentially life-threatening complication that requires immediate medical treatment.
What you need to know:
Read more
- Signing this form does not mean you will have an emergency postpartum bleeding.
- We will only include you in the study IF abnormal bleeding happens after your birth.
- If abnormal bleeding does happen, your doctors will first try the usual treatments that work in accordance with the hospital's PPH protocol.
- The study device (called Alma system) would only be used if the usual treatments do not stop the bleeding.
Treatment Schedule - Recruitment \& Consenting
- Screening and enrolment.
- Treatment of PPH with Alma system.
- Alma Survey
- Follow up examination post treatment procedure (after removal of Alma system and before subject discharge from the hospital).
- 6-week postpartum follow-up examination.
Read the detailed description
Visit 1 - Before Birth (Screening and Enrollment)
No study-related procedures will be done until you have reviewed and signed this consent form. The screening visit tests and procedures are done to see if you are eligible to be in the study. This visit could take a few hours to complete. During this visit, we will collect important background information and perform a physical examination. The following tests and procedures will take place:
- A purple bracelet will be placed on your wrist to indicate to the clinical team that you have signed this informed consent form. This helps ensure that, in the event of abnormal bleeding, you can be quickly identified as a participant in the study
- Demographic information: Including date of birth, race, height, weight, and number of previous childbirths.
- Medical History: This includes your past and current health conditions, with particular focus on gynecological issues, prior surgeries, current medications, and any known allergies
- Physical examination: including vital signs such as blood pressure and heart rate.
- Blood tests: including Complete Blood Count (CBC) and Coagulation Panel.
Neither you nor your health care plan/insurance carrier will be billed for the collection of the information that will be used for this study.
Visit 2 - Diagnosis and Treatment of Abnormal Bleedong and Post-Partum Hemorrhage (PPH) with the Alma System If you experience abnormal bleeding or postpartum hemorrhage (PPH), your doctor will evaluate all possible causes and follow the hospital's standard treatment protocols. Initial treatment typically includes medications to help the uterus contract and reduce bleeding, as well as manual uterine massage, as recommended by your medical team.
If those treatments do not work, your doctor may decide to use the Alma system to help control or reduce the bleeding.
Once the Alma system is in place, the medical team will perform an ultrasound to check that the device is placed correctly and remains stable.
In addition, the following data will be collected from the treating team:
- A questionnaire about how easy the Alma System was to use (Usability Questionnaire).
- The amount of time it took to use the Alma System.
- Your symptoms and any adverse events (your overall health).
- An evaluation of how well the Alma System worked (treatment evaluation). Visit 3 - Post Treatment Follow-up Examination Before you leave the hospital and after removal of the Alma system, your doctor will perform a follow-up exam.s,
This will include:
- Physical examination, blood tests, vital signs such as blood pressure and heart rate.
- Your symptoms and any adverse events (your overall health).
Visit 4 - 6-Week Postpartum Follow-up Examination and Study Completion
A final study follow-up assessment will take place at your routine 6-week postpartum follow-up check-up. The following assessments will be performed:
- Physical Examination
- Review of any adverse events Note: If you are unable to return for your routine 6-week postpartum check-up after three documented contact attempts, the study team will follow-up by phone to ask about your overall health since discharge. Any complaints will be investigated.
- Being tested
- Alma System
- Keywords
- Alma System, postpartum hemorrhage, pph
- 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 Obstetric-gynecologic specialized manual instrument, Vacuum induced heamorrhage control
Subjects diagnosed with abnormal bleeding or 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 |
|---|---|---|
| Participant group | Experimental | Woman who developed PPH after vaginal or caesarean delivery and first line interventions have been attempted and failed, and to which the Alma System was applied Receives: Device: Alma System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of safety events
Incidence, severity and seriousness of device-related Adverse Events (AEs).
Measured: 6 weeks
PPH control
Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Alma System per the Instructions for Use.
Measured: Procedure
Secondary outcomes (4)
Hemorrhage control
Time to control hemorrhage, defined as the time from turning on the vacuum source until the time the first of any of the following occurs:
- there is no blood being collected in the tubing or canister, or
- the blood loss is observed as leveled off in the canister, or
- blood loss is at a rate of < 500 ml in 24 hours.
Measured: minutes to hours
Surgical Intervention
Rate of surgical intervention required to control PPH after Alma use.
Measured: minutes to hours
Non Surgical intervention
Rate of non-surgical intervention as secondary medications (e.g.uterotonics, pain medications) required to control PPH after Alma use .
Measured: minutes to hours
Blood product transfusion
Rate of blood product transfusion required after Alma use, and number of transfusion units when administered.
Measured: hours to days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start11 Jan 2026
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Haemorrhage (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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ResQ Medical Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Chudnoff, MD, Study chair, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646653
- Sponsor's protocol ID
- CD-01-001-PR (pivotal)
- Acronym
- EVE
- Status last verified
- Mar 2026
- First submitted
- 15 Oct 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Alma System in Treating Abnormal Postpartum utErine Bleeding or Hemorrhage
- ClinicalTrials.gov ID
- NCT06646653
- Acronym / sponsor ID
- EVE / CD-01-001-PR (pivotal)
- Keywords
- Alma System, postpartum hemorrhage, pph
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ResQ Medical LtdUniversity, hospital or other
- Study start
- 11 Jan 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 17 Oct 2024 (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.
abnormal bleeding after childbirth. This condition is called abnormal bleeding and becomes a condition known as postpartum hemorrhage (PPH) when worsens. Abnormal bleeding is defined as the loss of more than 500 milliliters (about two cups) of blood after a vaginal birth, or more than 1,000 milliliters (about four cups) after a cesarean section. It is a serious and potentially life-threatening complication that requires immediate medical treatment.
What you need to know:
- Signing this form does not mean you will have an emergency postpartum bleeding.
- We will only include you in the study IF abnormal bleeding happens after your birth.
- If abnormal bleeding does happen, your doctors will first try the usual treatments that work in accordance with the hospital's PPH protocol.
- The study device (called Alma system) would only be used if the usual treatments do not stop the bleeding.
Treatment Schedule - Recruitment \& Consenting
- Screening and enrolment.
- Treatment of PPH with Alma system.
- Alma Survey
- Follow up examination post treatment procedure (after removal of Alma system and before subject discharge from the hospital).
- 6-week postpartum follow-up examination.
Detailed description
Visit 1 - Before Birth (Screening and Enrollment)
No study-related procedures will be done until you have reviewed and signed this consent form. The screening visit tests and procedures are done to see if you are eligible to be in the study. This visit could take a few hours to complete. During this visit, we will collect important background information and perform a physical examination. The following tests and procedures will take place:
- A purple bracelet will be placed on your wrist to indicate to the clinical team that you have signed this informed consent form. This helps ensure that, in the event of abnormal bleeding, you can be quickly identified as a participant in the study
- Demographic information: Including date of birth, race, height, weight, and number of previous childbirths.
- Medical History: This includes your past and current health conditions, with particular focus on gynecological issues, prior surgeries, current medications, and any known allergies
- Physical examination: including vital signs such as blood pressure and heart rate.
- Blood tests: including Complete Blood Count (CBC) and Coagulation Panel.
Neither you nor your health care plan/insurance carrier will be billed for the collection of the information that will be used for this study.
Visit 2 - Diagnosis and Treatment of Abnormal Bleedong and Post-Partum Hemorrhage (PPH) with the Alma System If you experience abnormal bleeding or postpartum hemorrhage (PPH), your doctor will evaluate all possible causes and follow the hospital's standard treatment protocols. Initial treatment typically includes medications to help the uterus contract and reduce bleeding, as well as manual uterine massage, as recommended by your medical team.
If those treatments do not work, your doctor may decide to use the Alma system to help control or reduce the bleeding.
Once the Alma system is in place, the medical team will perform an ultrasound to check that the device is placed correctly and remains stable.
In addition, the following data will be collected from the treating team:
- A questionnaire about how easy the Alma System was to use (Usability Questionnaire).
- The amount of time it took to use the Alma System.
- Your symptoms and any adverse events (your overall health).
- An evaluation of how well the Alma System worked (treatment evaluation). Visit 3 - Post Treatment Follow-up Examination Before you leave the hospital and after removal of the Alma system, your doctor will perform a follow-up exam.s,
This will include:
- Physical examination, blood tests, vital signs such as blood pressure and heart rate.
- Your symptoms and any adverse events (your overall health).
Visit 4 - 6-Week Postpartum Follow-up Examination and Study Completion
A final study follow-up assessment will take place at your routine 6-week postpartum follow-up check-up. The following assessments will be performed:
- Physical Examination
- Review of any adverse events Note: If you are unable to return for your routine 6-week postpartum check-up after three documented contact attempts, the study team will follow-up by phone to ask about your overall health since discharge. Any complaints will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant group | Experimental | Device: Alma SystemWoman who developed PPH after vaginal or caesarean delivery and first line interventions have been attempted and failed, and to which the Alma System was applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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: Obstetric-gynecologic specialized manual instrument, Vacuum induced heamorrhage controlSubjects diagnosed with abnormal bleeding or 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 | Participant group |
Primary outcome
Incidence of safety events
Time frame: 6 weeks
Incidence, severity and seriousness of device-related Adverse Events (AEs).
PPH control
Time frame: Procedure
Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Alma System per the Instructions for Use.
4 secondary outcomes
Hemorrhage control
Time frame: minutes to hours
Surgical Intervention
Time frame: minutes to hours
Non Surgical intervention
Time frame: minutes to hours
Blood product transfusion
Time frame: hours to 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 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Postpartum Haemorrhage (PPH)
RecruitingObservational study
Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia.
Thrombocytopenia, Postpartum Haemorrhage (PPH)
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.
Scott Chudnoff, MD study chair
Maimonides Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alma System in people with Postpartum Haemorrhage (PPH) and PPH, run by ResQ Medical Ltd at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yael Corcos, RN (972-548106010, yael@resq-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of safety events (time frame: 6 weeks). 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?
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 30 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.