Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Alma System in Treating Abnormal Postpartum utErine Bleeding or Hemorrhage
ResQ Medical Ltd
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 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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 contin…
Interventions
- DeviceAlma 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 HospitalBrooklyn, New York
- Shaare Zedek Medical CenterJerusalem