EVE TRIAL , ALMA SYSTAM
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorResQ Medical Ltd
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult Female, 18 years of age or older at time of consent.
Able to understand and provide informed consent to participate in the study.
Diagnosis of abnormal postpartum uterine bleeding or hemorrhage with suspected atony within 24 hours after vaginal or c-section delivery.
Failed first-line intervention of uterotonics and uterine massage/bimanual uterine massage to stop bleeding.
Disqualifiers
EBL >1500ml, to be determined when investigator is ready to have the Alma peel pack opened.
Delivery at a gestational age < 34 weeks.
For Cesarean-sections birth: Cervix < 3 cm dilated before use of Alma.
hysterectomy;
Trial design
Design model
Single group
Treatments tested in this trial
Alma System
DeviceSubjects 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Participant groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of safety events
Incidence, severity and seriousness of device-related Adverse Events (AEs).
Time frame
6 weeks2
PPH control
Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Alma System per the Instructions for Use.
Time frame
ProcedureSecondary outcomes
1
Hemorrhage control
Time to control hemorrhage, defined as the time from turning on the vacuum source until the time the first of any of the following occurs: * there is no blood being collected in the tubing or canister, or * the blood loss is observed as leveled off in the canister, or * blood loss is at a rate of \< 500 ml in 24 hours.
Time frame
minutes to hours2
Surgical Intervention
Rate of surgical intervention required to control PPH after Alma use.
Time frame
minutes to hours3
Non Surgical intervention
Rate of non-surgical intervention as secondary medications (e.g.uterotonics, pain medications) required to control PPH after Alma use .
Time frame
minutes to hours4
Blood product transfusion
Rate of blood product transfusion required after Alma use, and number of transfusion units when administered.
Time frame
hours to daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov