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RecruitingPhase 3

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Physical exams, Ultrasound, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "During this visit, we will collect important background information and perform a physical examination."
  • "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)."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the Alma system to stop heavy bleeding from the womb after childbirth. It is for women age 18 or older whose bleeding does not stop with usual medicines and womb massage.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a woman age 18 or older when you agree to join.
  • You can understand the study and give your consent.
  • You have abnormal bleeding from the womb within 24 hours after a vaginal birth or C-section. Doctors suspect your womb is not tightening enough.
  • When doctors are ready to open the Alma device, your estimated blood loss is 500–1,500 mL after vaginal birth or 1,000–1,500 mL after C-section.
  • Medicines that tighten the womb and womb massage have not stopped the bleeding.

Who can't join

  • Your estimated blood loss is over 1,500 mL when doctors are ready to open the device, or you gave birth before 34 weeks of pregnancy.
  • After a C-section, your cervix (the opening to the womb) is less than 3 cm open before Alma use.
  • Your bleeding needs stronger treatment, such as removing the womb, stitching it to control bleeding, or blocking or tying off blood vessels.
  • You have a known unusual womb shape, a tear in the womb, a womb that remains turned inside out, or a pregnancy still in the womb.
  • Your placenta is known to be attached too deeply, remains in the womb with known risks for deep attachment, or cannot be easily removed by hand.
  • You have already had a balloon, packing, or another suction device placed in the womb to treat this bleeding.
  • You currently have cervical cancer or an infection with pus in the vagina, cervix, or womb.
  • You have a diagnosed blood-clotting disorder.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

NY