Using the Alma System to treat severe bleeding after childbirth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the feasibility of the Alma System in treating primary postpartum hemorrhage (PPH) in women. The study involves 10 subjects who have experienced PPH, focusing on the safety and effectiveness of the Alma System in rapidly reducing or stopping bleeding caused by uterine atony. Key objectives include assessing the absence of serious adverse events, potential damage to reproductive organs, and the system's ability to effectively contract the uterus and reduce blood loss. The trial is conducted under strict ethical oversight to ensure participant safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shaare Zedek Medical Center
  Jerusalem, Israel Recruiting
• Maimonides Medical Center | Brooklyn, New York Hospital
  Brooklyn, New York, United States Not yet recruiting

Study contacts

• Study coordinator: Yael Corcos, RN
• Email: yael@resq-med.com
• Phone: 972-548106010

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting Hospital General Universitario Gregorio Marañon · Madrid · NCT07616349

• Carbetocin with calcium chloride to improve uterine contraction after elective cesarean

  This trial will test whether giving carbetocin together with calcium chloride helps the uterus stay contracted and reduces bleeding during scheduled cesarean deliveries at term.

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• Investigating how calcium affects carbetocin's ability to contract the uterus after cesarean delivery

  This study is testing if different levels of calcium can help carbetocin work better to make the uterus contract after a cesarean delivery to prevent heavy bleeding.

  Recruiting Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Toronto, Ontario · NCT06930391

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.