Safety and Effectiveness of the Alma System in Treating Primary Postpartum Hemorrhage
Alma system
Urogenital Diseases+11
+ Female Urogenital Diseases and Pregnancy Complications
+ Hemorrhage
Treatment Study
Summary
Study start date: September 9, 2024
Actual date on which the first participant was enrolled.This study is focused on evaluating the safety and effectiveness of the Alma System in treating primary postpartum hemorrhage, a condition where women experience heavy bleeding after giving birth. It involves women who have given birth vaginally in a hospital and have not responded to standard treatments for postpartum hemorrhage. The study aims to gather important information about the safety of using the Alma System, which could potentially offer a new treatment option for managing this condition and improve outcomes for affected women. Participants will first provide consent to join the study. If postpartum hemorrhage occurs, they will receive treatment with the Alma System. The study then includes two follow-up visits: one when the participant is discharged from the hospital and another six weeks after the treatment. During and after the procedure, researchers will monitor for any serious adverse events related to the device, any noticeable damage to the cervix, uterus, or vagina, and any occurrence of uterine inversion or folding. This will help assess the safety and potential risks associated with the Alma System.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Adult Female, 18 years of age or older at time of consent. 2. Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation. 3. Subjects who present with an atonic uterus for at least 10 minutes after expulsion of placement with failure to obtain contraction and/or Subjects who have lost blood post-partum \> = 500 ml and according to the Investigator's judgment, require an intervention. 4. Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding. Exclusion Criteria: 1. Subjects who do not provide informed consent to participate in the clinical investigation. 2. Subjects who deliver at a uterus size \< 34 weeks. 3. Subjects who have lost greater than 1000 ml of blood. 4. Subjects who have abnormal PT, PTT and INR 5. Subjects who present with retained placenta, uterine lacerations, or for any other conditions outside of atonic post-partum hemorrhage. 6. 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. 7. Placental 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. 8. Known uterine rupture. 9. Unresolved uterine inversion.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
UNIVERSITY OF NAIROBI (UoN) COLLEGE OF HEALTH SCIENCES
Nairobi, KenyaOpen UNIVERSITY OF NAIROBI (UoN) COLLEGE OF HEALTH SCIENCES in Google Maps