NCT06646653 · ResQ Medical Ltd
EVE TRIAL , ALMA SYSTAM
(EVE)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
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.
Where
- Brooklyn, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations