RECRUITINGPhase 3INTERVENTIONAL

EVE TRIAL , ALMA SYSTAM

Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Alma System in Treating Abnormal Postpartum utErine Bleeding or Hemorrhage

About This Trial

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 May Be Eligible (Plain English)

1. Adult Female, 18 years of age or older at time of consent. 2. Able to understand and provide willing to sign a consent form to participate in the study. 3. Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery. 4. 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 5. 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 1. EBL \>1500ml, to be determined when investigator is ready to have the Alma peel pack opened. 2. Delivery at a gestational age \< 34 weeks. 3. For Cesarean-sections birth: Cervix \< 3 cm dilated before use of Alma. 4. PPH that the investigator determines to require more aggressive treatment, including any of the following: 1. hysterectomy; 2. b-lynch suture; 3. uterine artery embolization or ligation; 4. hypogastric ligation. 5. Known uterine anomaly. 6. Ongoing intrauterine pregnancy. 7. Placenta abnormality including any of the following: 1. known placenta accreta; 2. retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa); 3. retained placenta without easy manual removal. 8. Known uterine rupture. 9. Unresolved uterine inversion. 10. 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. 11. Current cervical cancer. 12. Current purulent infection of vagina, cervix, uterus. 13. Diagnosis of coagulopathy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

1. Adult Female, 18 years of age or older at time of consent. 2. Able to understand and provide informed consent to participate in the study. 3. Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery. 4. 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 5. 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 1. EBL \>1500ml, to be determined when investigator is ready to have the Alma peel pack opened. 2. Delivery at a gestational age \< 34 weeks. 3. For Cesarean-sections birth: Cervix \< 3 cm dilated before use of Alma. 4. PPH that the investigator determines to require more aggressive treatment, including any of the following: 1. hysterectomy; 2. b-lynch suture; 3. uterine artery embolization or ligation; 4. hypogastric ligation. 5. Known uterine anomaly. 6. Ongoing intrauterine pregnancy. 7. Placenta abnormality including any of the following: 1. known placenta accreta; 2. retained placenta with known risk factors for placenta accreta (e.g. history of prior uterine surgery, including prior c-section and placenta previa); 3. retained placenta without easy manual removal. 8. Known uterine rupture. 9. Unresolved uterine inversion. 10. 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. 11. Current cervical cancer. 12. Current purulent infection of vagina, cervix, uterus. 13. Diagnosis of coagulopathy.

Treatments Being Tested

DEVICE

Alma System

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.

Locations (2)

Maimonides Medical Center | Brooklyn, New York Hospital

Brooklyn, New York, United States

Shaare Zedek Medical Center

Jerusalem, Israel